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

Model Number 3855

Device Problems Break (1069); Difficult to Advance (2920)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/09/2020

Event Type  malfunction  

Event Description

It was reported that the shaft broke.A 15mmx3.50mm wolverine coronary cutting balloon was selected for use.Upon introduction, device had trouble in traveling through the guide and when pushed that shaft broke outside patient's body.The balloon never exited the guide into the artery.The device was pulled out from the guide.The procedure completed with a different device.No patient complications were reported.

Event Description

It was reported that the shaft broke.A 15mmx3.50mm wolverine coronary cutting balloon was selected for use.Upon introduction, device had trouble in traveling through the guide and when pushed that shaft broke outside patient's body.The balloon never exited the guide into the artery.The device was pulled out from the guide.The procedure completed with a different device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.A visual examination identified that the balloon folds were tightly wrapped.No issues were noted with the balloon of the device that may have potentially contributed to the complaint incident.The markerbands and blades and tip section of the device were visually and microscopically examined, and no issues were noted with the markerbands, blades or tip of the device that may have potentially contributed to the complaint incident.All blades were present and fully bonded to the balloon material.A visual and tactile examination found that the device was received in two sections as a result of a break in the hypotube.The break was located at 26.5 cm distally from the distal end of strain relief.The hypotube was kinked at various locations of the shaft.This type of damage is consistent with excessive force that could have been applied to the delivery system.A visual and tactile examination of the extrusion shaft found no issues with the extrusion shaft.No other issues were identified during the product analysis.

• 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: 11018940
• MDR Text Key: 221826217
• Report Number: 2134265-2020-17858
• Device Sequence Number: 1
• Product Code: NWX
• UDI-Device Identifier: 08714729888376
• UDI-Public: 08714729888376
• 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: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/19/2022
• Device Model Number: 3855
• Device Catalogue Number: 3855
• Device Lot Number: 0026212021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2021
• Date Manufacturer Received: 01/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1