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

Model Number 3854

Device Problems Break (1069); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/01/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: date of event was approximated to (b)(6) 2021 as no event date was reported.

Event Description

It was reported that the shaft broke.A 10mmx4.00mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the shaft broke in the guide after getting kinked.There were no patient complications reported.

Event Description

It was reported that the shaft broke.A 10mmx4.00mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the shaft broke in the guide after getting kinked.There were no patient complications reported.It was further reported that the device was simply pulled out and no fragments were left in the patient's body.

Manufacturer Narrative

B3 date of event: date of event was approximated to (b)(6) 2021 as no event date was reported.

• Brand Name: WOLVERINE CORONARY CUTTING BALLOON
• Type of Device: CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11860930
• MDR Text Key: 251933386
• Report Number: 2134265-2021-06551
• Device Sequence Number: 1
• Product Code: NWX
• UDI-Device Identifier: 08714729888307
• UDI-Public: 08714729888307
• Combination Product (y/n): N
• PMA/PMN Number: P950020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/08/2023
• Device Model Number: 3854
• Device Catalogue Number: 3854
• Device Lot Number: 0026603828
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1