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

Model Number 3852

Device Problem Material Puncture/Hole (1504)

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

Event Date 01/27/2021

Event Type  malfunction  

Event Description

It was reported that shaft hole occurred.The 90% stenosed target lesion was located in the mildly tortuous distal left circumflex artery.A 15mmx2.25mm wolverine coronary cutting balloon was advanced, but when 6 atm of pressure was applied, the balloon did not expand and a contrast leak was noted.After the device was removed, a hole in the shaft about 10cm from the tip was noted, in a location that was thought to have been inside the coronary artery.The procedure was completed with another of the same device.No complications were reported and there was no patient injury.

Event Description

It was reported that shaft hole occurred.The 90% stenosed target lesion was located in the mildly tortuous distal left circumflex artery.A 15mmx2.25mm wolverine coronary cutting balloon was advanced, but when 6 atm of pressure was applied, the balloon did not expand and a contrast leak was noted.After the device was removed, a hole in the shaft about 10cm from the tip was noted, in a location that was thought to have been inside the coronary artery.The procedure was completed with another of the same device.No complications were reported and there was no patient injury.

Manufacturer Narrative

A visual examination of the returned device identified that the balloon wings were tightly wrapped.The returned device was attached to a boston scientific encore inflation unit and positive pressure was applied; the balloon was inflated to its rate of burst pressure of 12 atmospheres and pressure held for 30 seconds without issue.A vacuum was then applied.The inflation device was verified at 12 atmospheres, before and after use with a calibrated pressure gauge.This inflation to 12 atmospheres was repeated three times with no leaks or drop in pressure noted.No issues were identified with balloon inflation or the balloon material.The blades of the device were visually and microscopically examined, and no issues were noted that may have potentially contributed to the complaint incident.All blades were present and fully bonded to the balloon surface.A visual and tactile examination identified no issues along the hypotube or shaft polymer extrusion of this device.No holes in the outer lumen of the device were identified.No issues were noted with the tip section of the device.A visual and microscopic examination found no issue with the marker bands.No issues were identified during the product analysis.

• Brand Name: WOLVERINE CORONARY CUTTING BALLOON MONORAIL
• 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: 11329985
• MDR Text Key: 232023138
• Report Number: 2134265-2021-01739
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/21/2022
• Device Model Number: 3852
• Device Catalogue Number: 3852
• Device Lot Number: 0026051549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2021
• Date Manufacturer Received: 03/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1