MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING

Model Number	3853
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/26/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.A 3.75mm x 12mm nc emerge balloon catheter and a 6mmx3.25mm wolverine balloon catheter were selected for use.However, during procedure, the shafts were snapped when attempted to cross the lesion.The procedure was completed with a different device.No patient complications were reported and the patient was 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 of the hypotube located approximately 85mm distal of the strain relief.The hypotube was also noted to be severely kinked along its entire length.This type of damage is consistent with excessive force being applied to the delivery system.No other issues were noted with the hypotube that may have contributed to the complaint incident.An examination of the returned device identified inflation media inside the balloon, indicating that it had been inflated.It is not known when the device was subjected to positive pressure.No issues were identified with the balloon which could potentially have contributed to this complaint.A visual and microscopic examination identified no damage to the markerbands or blades of the device.All blades were present and fully bonded to the balloon material.A microscopic examination identified no damage to the tip of the device.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that shaft break occurred.A 3.75mm x 12mm nc emerge balloon catheter and a 6mmx3.25mm wolverine balloon catheter were selected for use.However, during procedure, the shafts were snapped when attempted to cross the lesion.The procedure was completed with a different device.No patient complications were reported and the patient was fine.

• Brand Name: WOLVERINE CORONARY CUTTING BALLOON
• Common Device Name: CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9106524
• Report Number: 2134265-2019-11114
• Device Sequence Number: 1776359
• Product Code: NWX
• UDI-Device Identifier: 08714729888185
• UDI-Public: 08714729888185
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2019

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: 02/14/2020
• Device Model Number: 3853
• Device Catalogue Number: 3853
• Device Lot Number: 0021747092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Initial Date Received by Manufacturer: 09/03/2019
• Supplement Date Received by Manufacturer: 10/16/2019
• Initial Report FDA Received Date: 09/23/2019
• Supplement Report FDA Received Date: 11/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1