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

Model Number 3852

Device Problems Inflation Problem (1310); Material Puncture/Hole (1504)

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

Event Date 03/26/2021

Event Type  malfunction  

Event Description

It was reported that there was a hole in the balloon shaft.The 90% stenosed target lesion was located in the severely tortuous and severely calcified left circumflex artery.A 15mm x 3.00mm wolverine coronary cutting balloon was selected for use.During procedure, it was noted that there was a hole in the proximal balloon shaft part and it could not be inflated.The device was simply removed from the patient's body.The procedure was completed with another of same device.No patient complications were reported.

Event Description

It was reported that there was a hole in the balloon shaft.The 90% stenosed target lesion was located in the severely tortuous and severely calcified left circumflex artery.A 15mm x 3.00mm wolverine coronary cutting balloon was selected for use.During procedure, it was noted that there was a hole in the proximal balloon shaft part and it could not be inflated.The device was simply removed from the patient's body.The procedure was completed with another of same device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.Balloon, blades and pads: a visual examination identified that the balloon wings were found to tightly wrapped and had not been subjected to positive pressure.Blood was visible inside 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.The device was returned with a stopcock attached.Blood was visible inside the hub of the device.The corewire of the device was found to be protruding through the outer wall of the shaft polymer extrusion at approx.6cm distal from the guidewire port.Inflation of the device was attempted using an encore inflation device, but inflation of the balloon did not occur due to a leak at the corewire puncture site.

• 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: 11675274
• MDR Text Key: 245793074
• Report Number: 2134265-2021-04898
• 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: 05/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/22/2023
• Device Model Number: 3852
• Device Catalogue Number: 3852
• Device Lot Number: 0026849826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2021
• Date Manufacturer Received: 05/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1