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

Model Number 3854

Device Problem Break (1069)

Patient Problems No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)

Event Date 01/05/2021

Event Type  malfunction  

Event Description

It was reported that shaft break occurred.A 10mm x 2.75mm wolverine coronary cutting balloon was selected for use.During the procedure, upon advancing the balloon through the guide over a wire, it was noted that the shaft proximal to the entry point snapped in half.The device was removed completely from the guide without any intervention or devices needed.The procedure was completed with a different device.There was no unusual handling of the balloon prior to entry into the guide and the hemostasis valve was open as well.No patient complications were reported.

Event Description

It was reported via maude report 3600840000-2021-8005 that shaft break occurred.A 10mm x 2.75mm wolverine coronary cutting balloon was selected for use.During the procedure, upon advancing the balloon through the guide over a wire, it was noted that the shaft proximal to the entry point snapped in half.The device was removed completely from the guide without any intervention or devices needed.The procedure was completed with a different device.There was no unusual handling of the balloon prior to entry into the guide and the hemostasis valve was open as well.No patient complications were reported.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.Blades and pads: a visual examination identified that the balloon wings were found to be tightly wrapped and had not been subjected to positive pressure.There were no issues noted with the balloon material.All blades were securely bonded and no damage to the blades were noted.No issues were noted with the tip section of the device.A visual and microscopic examination found no issue with the marker bands.A visual and tactile examination was completed on the shaft of the device.A hypotube break was identified at 53 cm distally from the strain relief.Multiple hypotube kink was also noted on the length of the device.

• 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: 11238011
• MDR Text Key: 228965980
• Report Number: 2134265-2021-00599
• Device Sequence Number: 1
• Product Code: NWX
• UDI-Device Identifier: 08714729888253
• UDI-Public: 08714729888253
• 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: 03/22/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 08/07/2022
• Device Model Number: 3854
• Device Catalogue Number: 3854
• Device Lot Number: 0025828750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2021
• Initial Date Manufacturer Received: 01/11/2021
• Initial Date FDA Received: 01/27/2021
• Supplement Dates Manufacturer Received: 02/25/2021
• Supplement Dates FDA Received: 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 112