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

Model Number	H749CBM3400100
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.  (b)(4).
Event or Problem Description
It was reported that a shaft break occurred.A 4.00 x 10 mm flextome® cutting balloon® was selected for use.During the procedure, when the device was inserted into the tip of the guide catheter, it was noted that the balloon catheter broke.Another 4.00 x 10 mm flextome® cutting balloon® was used, however it was kinked.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: 6461579
• Report Number: 2134265-2017-03578
• Device Sequence Number: 13594071
• Product Code: NWX
• UDI-Device Identifier: 08714729808398
• UDI-Public: (01)08714729808398(17)20190304(10)0018997381
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• Report Date (Section B): 03/28/2017

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: 03/04/2019
• Device Model Number: H749CBM3400100
• Device Catalogue Number: CBM340010
• Device Lot Number: 0018997381
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2017
• Initial Report FDA Received Date: 04/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1