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	08/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event date is an estimated date based on the aware date as the exact event date was not reported.
Event or Problem Description
It was reported that the balloon broke upon removal.A 10mmx3.50mm wolverine coronary cutting balloon and 6f guidezilla ii guide extension catheter were selected for use.During procedure, it was noted that the balloon broke when trying to remove from the inside of the guidezilla catheter.There were no patient complications 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: 10515497
• Report Number: 2134265-2020-12433
• Device Sequence Number: 14064770
• Product Code: NWX
• UDI-Device Identifier: 08714729888284
• UDI-Public: 08714729888284
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/10/2020

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: 11/23/2021
• Device Model Number: 3854
• Device Catalogue Number: 3854
• Device Lot Number: 0024822782
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/20/2020
• Initial Report FDA Received Date: 09/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1