MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY FLEXTOME® CUTTING BALLOON®; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	H749CBO3400150
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported the balloon detachment occurred.A 15mmx4mm flextome cutting balloon as selected for use.During unpacking, it was noted that the balloon was disconnected from the delivery catheter as it was taken out of the package.The procedure was completed with another of the same device.No patient complications reported patient status was good.
Additional Manufacturer Narrative
Device evaluated by manufacturer: device was returned for analysis.A visual and microscopic examination identified that the balloon had completely detached from the device approximately 7mm proximal to the proximal edge of the proximal markerband.The entire balloon was completely detached from the device and was not returned for analysis.A visual and microscopic examination identified a 2mm hole in the outer shaft polymer extrusion approximately 8mm proximal to the proximal edge of the proximal markerband.This damage may have occurred when the balloon became detached from the device.Multiple kinks were also noted along the entire length of the shaft.This type of damage is consistent with excessive force being applied to the delivery system.The blades and tip were also noted to be completely detached from the device and were not returned for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause was unable to be determined.Bsc id# (b)(4).Tw# (b)(4).
Event or Problem Description
It was reported the balloon detachment occurred.A 15mmx4mm flextome® cutting balloon® as selected for use.During unpacking, it was noted that the balloon was disconnected from the delivery catheter as it was taken out of the package.The procedure was completed with another of the same device.No patient complications reported patient status was good.

• Brand Name: FLEXTOME® CUTTING BALLOON®
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6687597
• Report Number: 2134265-2017-06482
• Device Sequence Number: 11202566
• Product Code: NWX
• UDI-Device Identifier: 08714729808756
• UDI-Public: (01)08714729808756(17)20180311(10)17785349
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P950020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/11/2018
• Device Model Number: H749CBO3400150
• Device Catalogue Number: CBO340015
• Device Lot Number: 17785349
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2017
• Initial Date Received by Manufacturer: 06/13/2017
• Supplement Date Received by Manufacturer: 07/20/2017
• Initial Report FDA Received Date: 07/05/2017
• Supplement Report FDA Received Date: 08/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1