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

Model Number	H749CBM3300100
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Patient Involvement (2645)
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 detachment occurred.A 10 mm x 3.00 mm flextome® cutting balloon® was selected for use.During unpacking, it was noted that the stylet was separated from the cutting balloon.No patient complications reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: device was returned for analysis.A visual and tactile examination identified a complete break in the midshaft of the device 1165mm distal to the strain relief.It was noted that 75mm of corewire remained fully attached to the shaft of the device.This damage identified is consistent with excessive force being applied to the delivery system.No issues were noted with the shaft that may have contributed to the complaint incident.A visual and tactile examination identified multiple kinks along the length of the hypotube.This damage identified is consistent with excessive force being applied to the delivery system.No issues were noted with the hypotube that may have contributed to the complaint incident.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).
Event or Problem Description
It was reported that detachment occurred.A 10mm x 3.00mm flextome® cutting balloon® was selected for use.During unpacking, it was noted that the stylet was separated from the cutting balloon.No patient complications reported.

• Brand Name: FLEXTOME® CUTTING BALLOON®
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6814974
• Report Number: 2134265-2017-08588
• Device Sequence Number: 1760936
• Product Code: NWX
• UDI-Device Identifier: 08714729808350
• UDI-Public: (01)08714729808350(17)20200517(10)0020659055
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 08/07/2017

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: 05/17/2020
• Device Model Number: H749CBM3300100
• Device Catalogue Number: CBM330010
• Device Lot Number: 0020659055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2017
• Initial Date Received by Manufacturer: 08/07/2017
• Supplement Date Received by Manufacturer: 09/22/2017
• Initial Report FDA Received Date: 08/23/2017
• Supplement Report FDA Received Date: 10/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1