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 Patient Involvement (2645)
Date of Event	12/06/2018
Type of Reportable Event	Malfunction
Event or Problem Description
To: it was reported that a shaft break occurred.A 10mmx4.00mm wolverine coronary cutting balloon shaft broke in half during preparation, outside the patient.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: 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 260mm 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.A microscopic examination identified damage to the tip.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 due to the presence of inflation media inside the balloon, the device was subjected to positive pressure.It is not known when the balloon was inflated.No issues were noted with the balloon that may have potentially contributed to the complaint incident.
Event or Problem Description
It was reported that a shaft break occurred.A 10mmx4.00mm wolverine coronary cutting balloon shaft broke in half during preparation, outside the patient.No patient complications were reported.

• 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: 8164895
• Report Number: 2134265-2018-64065
• Device Sequence Number: 2179050
• 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
• 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): 02/12/2019

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: 05/17/2020
• Device Model Number: 3854
• Device Catalogue Number: 3854
• Device Lot Number: 0022137943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Initial Date Received by Manufacturer: 12/11/2018
• Supplement Date Received by Manufacturer: 01/22/2019
• Initial Report FDA Received Date: 12/14/2018
• Supplement Report FDA Received Date: 02/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1