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

Model Number	3854
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/22/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The 70% stenosed target lesion was located in the left anterior descending artery.A 10mm x 3.50mm wolverine coronary cutting balloon was used to dilate the lesion.When the wolverine was advanced through the guide into the lesion, the balloon shaft broke off the main part of the balloon.The break was less than 15cm from the hub.The wolverine was removed and a non bsc device was used to remove the balloon component and the procedure was completed.No adverse events were noted to the patient.
Event or Problem Description
It was reported that a shaft break occurred.The 70% stenosed target lesion was located in the left anterior descending artery.A 10mm x 3.50mm wolverine coronary cutting balloon was used to dilate the lesion.When the wolverine was advanced through the guide into the lesion, the balloon shaft broke off the main part of the balloon.The break was less than 15cm from the hub.The wolverine was removed and a non bsc device was used to remove the balloon component and the procedure was completed.No adverse events were noted to the patient.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 at approximately 200mm distal to the strain relief.The hypotube was also noted to be severely 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 microscopic examination identified damage to the tip.This type of damage is consistent with the device encountering resistance when attempting to cross a lesion.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 visual examination identified that the balloon was not subjected to positive pressure.No issues were noted with the balloon that may have potentially contributed to the complaint incident.No other issues were identified during the product analysis.

• 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: 8072409
• Report Number: 2134265-2018-62825
• Device Sequence Number: 11301321
• Product Code: NWX
• UDI-Device Identifier: 08714729888284
• UDI-Public: 08714729888284
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 12/14/2018

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 Expiration Date: 08/02/2020
• Device Model Number: 3854
• Device Catalogue Number: 3854
• Device Lot Number: 0022465375
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2018
• Initial Date Received by Manufacturer: 10/22/2018
• Supplement Date Received by Manufacturer: 11/22/2018
• Initial Report FDA Received Date: 11/14/2018
• Supplement Report FDA Received Date: 12/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR