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

Model Number	H749CBM3200060
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/11/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 year and above.(b)(4).
Event or Problem Description
It was reported that shaft detachment occurred.A 6mmx2mm flextome cutting balloon® was use to dilate the lesion.After the procedure when the device was removed from the patient, it was noted that balloon catheter was all torn apart and destroyed.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The investigator observed that the hypotube was kinked in multiple locations.This type of damage is consistent with excessive force being applied to the delivery system when being handled.The midshaft was severely stretched and flattened along its entire length.This type of damage is consistent with excessive tensile force having been applied to the shaft.No damage was observed to the tip, blades or balloon.Then balloon folds were relaxed.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical/procedural factors.(b)(4).
Event or Problem Description
It was reported that shaft detachment occurred.A 6mmx2mm flextome® cutting balloon® was use to dilate the lesion.After the procedure when the device was removed from the patient, it was noted that balloon catheter was all torn apart and destroyed.No patient complications were reported.

• Brand Name: FLEXTOME® CUTTING BALLOON®
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6145966
• Report Number: 2134265-2016-11001
• Device Sequence Number: 10925531
• Product Code: NWX
• UDI-Device Identifier: 08714729808220
• UDI-Public: (01)08714729808220(17)20181119(10)0018657543
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2016

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: 11/19/2018
• Device Model Number: H749CBM3200060
• Device Catalogue Number: CBM320006
• Device Lot Number: 0018657543
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/14/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/05/2016
• Supplement Report FDA Received Date: 02/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1