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 Codes	Break (1069); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/14/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was fractured.The 80% stenosed target lesion was located in the mildly tortuous and moderately calcified left anterior descending artery.A 15mm x 3.00mm wolverine coronary cutting balloon was selected for use.Upon insertion, resistance was met inside the guide catheter and force was exerted which caused the fracture of the device.The device was removed and another balloon was used to complete the procedure.There were no complications reported and patient was unaffected.

• 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: 10527977
• Report Number: 2134265-2020-12397
• Device Sequence Number: 3056123
• Product Code: NWX
• UDI-Device Identifier: 08714729888352
• UDI-Public: 08714729888352
• 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
• Report Date (Section B): 09/14/2020

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: 06/11/2021
• Device Model Number: 3855
• Device Catalogue Number: 3855
• Device Lot Number: 0023939930
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2020
• Initial Report FDA Received Date: 09/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1