1. Balloon Project Summary
Interface Extrusion Qualification

2. Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally2
Extrusion Qualification
Goals:
Validate Interface Internal Extrusion
Use Interface Balloon Data
Significantly Reduce Balloon Component Cost
-Lower service level and reduce backorder risk
-Significantly Increase Interface balloon yield
-Significantly Reduce Scrap BSC in IQA
-Use Interface Data to decrease IQA cost

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Extrusion Qualification
Strategy:
- Identical Inspection & Measurement Methods
- Validate methods at BSC and Interface
- Transition to “Supplied Data” via Interface
- Eliminate BSC 100% proof loading

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Extrusion Qualification
Requirements:
-Continue current strategy to validate internal extrusion
- Manage measurement anomalies
- Document SCARs and NCMRs
- PpK evaluation memos
- Supplier Quality, Sustaining R&D and DA
- Document & Lock Requirements
-Purchase Interface inspection station ($35K)
- Duplicate Interface measurement method
-Equipment Lead-Time – Four to Five Weeks
-Develop and Validate BSC and Interface Inspection procedures
-Execute Design and Process changes:
- Align balloon burst requirement with finished device
- IQA lot acceptance per AQL 95/99.9 confidence.

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Extrusion Qualification
Estimate for Method Validation:
-$13K EE IV/O of Inspection Station
-$20K for MG Sustaining Engineering
-$15K for Travel (SJ and Maple Grove)

6. Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally6
Extrusion Qualification
Quarter Scrap FARF IQA Labor External
Extrusion
Q1 $15,700 $2,000 $25,000
Q2 $31,000 $3,500 $46,400
Q3 $33,000 $4,000 $45,000
Q4 $17,000 $2,000 $35,000
Total $96,700 $11,500 $151,400
Interface Requirements for legacy balloons:
Pay for extrusion
Pay for scrap
Cost Incurred & Forecast

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Detail & Back-UP Slides
Detail & Back-UP Slides

8. Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally8
Balloons for Measurement
Balloon Part Numbers and Inspection Priority
BSC P/N Size Priority SO PO# Qty
Request
Ship date
Received
date
Interface
WO#
BSC
Batch #
FA
Status Comment
12565 2.5x103 1 17468 6234623 31 27-Oct 28-Oct N/A 5001026435 Done Completed. See CR 1017380
11800 2.5x20 1 17468 6234623 31 27-Oct 28-Oct N/A 5001025939 Done Completed. See CR 1017380
12468 5.0x103 2 17472 6234624 31 8-Oct 1-Oct N/A 5001014922 In CR Pending CR 1019813
11597 5.0x20 2 17472 6234624 31 8-Oct 28-Sep N/A 5001013157 In CR Pending CR 1019813
11598 6.0x20 3 17473 6234603 31 15-Oct 1-Oct N/A 5001014921 Passed Pending FAIR approval
12469 6.0x103 3 17473 6234603 31 21-Oct 12-Oct N/A 5001020041 Failed
Balloon Length failed
Statistical & practical test
11802 3.5x20 5 17476 6234614 31 22-Oct 7-Oct N/A 5001017602 Passed Pending FAIR approval
13158 3.5x103 5 17476 6234614 31 22-Oct N/A 5001040707 Passed Pending FAIR approval
11599 7.0x20 4 17474 6234610 31 22-Oct 8-Oct N/A 5001018219 Passed
Pending FAIR approval by
John L.
12044 7.0x83 4 17474 6234610 31 22-Oct 15-Oct N/A 5001021097 Failed
Rejected due to Banana
Shape Pending NCMR E-
6879
12575 2.0x103 6 17454 6234616 31 26-Oct 21-Oct N/A 5001023633 Failed
Balloon Length failed
Statistical & practical test
11799 2.0x20 6 17454 6234616 31 26-Oct 21-Oct N/A 5001023634 Failed
Balloon length failed Ppk. 0.95
from measurement < 1.33
11804 2.0x23 6 17454 6234616 31 26-Oct 4-Nov N/A 5001029716 Failed
Balloon length failed Ppk. 0.53
from measurement < 1.33
(Linda)
11809 2.0x40 6 17454 6234616 31 26-Oct 21-Oct N/A 5001023635 Failed
Balloon length failed Ppk. 0.48
from measurement < 1.33
(Linda)
12567 4.0x103 7 17477 6234803 31 1-Nov 2-Nov N/A 5001028393 Pending
P value too low. Need more
study
11596 4.0x20 7 17477 6234803 31 1-Nov 29-Oct N/A 5001027025 Pending
P value too low. Need more
study
11600 8.0x20 8 17471 6234612 31 25-Oct 28-Oct N/A 5001026431 Passed FAIR OK. Pending approval
11615 8.0x43 8 17471 6234612 31 25-Oct N/A Not Received
12566 3.0x103 9 17475 6234779 31 29-Oct 29-Oct N/A 5001027024 Pending In Work
11801 3.0x20 9 17475 6234779 31 29-Oct 28-Oct N/A 5001025936 Pending
Missing Page 3 double wall
thickness measurement. IQA
redo

9. Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally9
Methods & Measurement
Details:
Methods / Measurement Processes
Review Procedures
Evaluate Interface & BSC Processes
Methods Required:
Balloon Body Dimensions
Duplicate Interface Inspection Station
Equipment Capital Cost – Interface Quote
BSC to adopt Interface method for Stem IDs’
Burst
Validate Interface Balloon Component Burst Process
Interface burst data (AQL, 95/99.9 confidence)
Validate BSC and Interface DWT Measurement Processes

10. Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally10
Methods & Measurement

11. Boston Scientific Confidential -- For Internal Use Only. Do Not Copy, Display or Distribute Externally11
Methods & Measurement
ID Task Name Duration Start Finish Resource
Names
1 Methods 112 days Mon 4/12/10 Tue 9/14/10
2 review MGwork instructions, validations, observe process in MG 5 days Mon 4/12/10 Fri 4/16/10 John H
3 review SJ QP 1006 procedures 10 days Mon 4/12/10 Fri 4/23/10 John H
4 review / observe SJ incomingprocesses / equipment 5 days Mon 4/26/10 Fri 4/30/10 John H
5 Draft new IP 35 days Mon 4/12/10 Fri5/28/10
10 Interface Visit 1 day Tue 4/27/10 Tue 4/27/10
15 Draft TMV (gage R&Rs) protocols 10 days Fri 5/28/10 Fri6/11/10
20 Equipment 80 days Mon 4/12/10 Fri7/30/10 RonLee
26 Update IP drafts 10 days Mon 7/5/10 Fri 7/16/10 John H
27 Update TMV (gage R&Rs) protocols 10 days Mon7/5/10 Fri7/16/10
32 IP Due Diligence (verifygage R&Rs, trainoperators) 10 days Mon 7/19/10 Fri7/30/10
36 Update IP and TMVs 5 days Mon8/2/10 Fri 8/6/10
40 Release IP to Numeric 5 days Mon 8/9/10 Fri 8/13/10 John H
41 Execute TMVs 10 days Mon 8/16/10 Fri8/27/10 JohnH
45 Write TMRs and CR 7 days Mon 8/30/10 Tue 9/7/10
49 Release IP to Alpha 5 days Wed 9/8/10 Tue 9/14/10 John H
50 Update prints (?) touse new IP 5 days Wed 9/8/10 Tue 9/14/10 R&D
JohnH
John H
M T W T F S S M T W T F S S
Apr 11, '10 Apr 18, '10 Apr