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

Model Number	3855
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/27/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was cancelled and the patient was sent for surgery.The 85% stenosed, eccentric, type 1 target lesion was located in the mildly tortuous and moderately calcified first diagonal artery.A 15mmx2.00mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon was unable to cross the lesion.The procedure was aborted and the patient was sent for surgery.No further 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: 10436967
• Report Number: 2134265-2020-10752
• Device Sequence Number: 2727126
• Product Code: NWX
• UDI-Device Identifier: 08714729888314
• UDI-Public: 08714729888314
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• 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
• Report Date (Section B): 08/20/2020

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: 12/07/2020
• Device Model Number: 3855
• Device Catalogue Number: 3855
• Device Lot Number: 0023053338
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/29/2020
• Initial Report FDA Received Date: 08/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1