MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WOLVERINE¿ CORONARY CUTTING BALLOON® MONORAIL®; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING

Model Number	H74939401104000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that a shaft break occurred.The target lesion was located in the superficial femoral artery.As the 10mmx4.00mm wolverine coronary cutting balloon monorail was being introduced, the device came apart with the inflation lumen section separating at the monorail section.The device was removed by pulling back the guide and the procedure completed with a different device no patient complications were reported and the patient's status is fine.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was received in two sections as the result of a break in the hypotube.A visual and tactile examination identified a complete break in the hypotube of the device.The break was located approximately 900mm distal of the strain relief.The hypotube was also noted to be kinked at several locations along its length.This type of damage 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.A visual and tactile examination identified that the shaft polymer extrusion was severely kinked along its entire length.This type of damage 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 examination identified that the balloon was subjected to positive pressure.It is not known when the device was subjected to positive pressure.An examination of the balloon identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination identified no damage to the tip, markerbands or blades of the device.All blades were present and fully bonded to the balloon material.No other issues were identified during the product analysis.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).
Event or Problem Description
It was reported that a shaft break occurred.The target lesion was located in the superficial femoral artery.As the 10mmx4.00mm wolverine coronary cutting balloon monorail was being introduced, the device came apart with the inflation lumen section separating at the monorail section.The device was removed by pulling back the guide and the procedure completed with a different device no patient complications were reported and the patient's status is fine.

• Brand Name: WOLVERINE¿ CORONARY CUTTING BALLOON® MONORAIL®
• Common Device Name: CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7664311
• Report Number: 2134265-2018-05913
• Device Sequence Number: 19464683
• Product Code: NWX
• UDI-Device Identifier: 08714729888307
• UDI-Public: 08714729888307
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P950020/S072
• 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): 06/12/2018

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 Model Number: H74939401104000
• Device Catalogue Number: 39401-10400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2018
• Initial Date Received by Manufacturer: 06/12/2018
• Supplement Date Received by Manufacturer: 07/13/2018
• Initial Report FDA Received Date: 07/05/2018
• Supplement Report FDA Received Date: 08/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1