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 Integrity Problem (2978)

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

Event Date 01/08/2021

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.A visual examination identified that the balloon was in deflated state and had been subjected to positive pressure.Blood was evident in the proximal and distal balloon cones.There were no issues noted with the balloon material.All blades were securely bonded and no damage to the blades were noted.A rupture in the outer lumen material was identified at 11.8 cm proximally from the tip and this extended proximally for 4 mm.The outer lumen of the shaft poly extrusion was stretched and damaged from the distal edge of the rupture and this extended proximally for a length of 3.2 cm.A severe hypotube kink was noted at 82.1 cm distal from the strain relief.A visual and microscopic examination found no issue with the marker bands.

Event Description

Reportable based on device analysis completed on 12mar2021.It was reported that the shaft was inflated.A 15mmx2.75mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the device was inflated about 10cm from the tip of the distal shaft but no rupture was noted.The usage was discontinued, and procedure was completed a different device.No patient complications were reported.However, device analysis revealed balloon rupture.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 11619569
• MDR Text Key: 243953604
• Report Number: 2134265-2021-04144
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/17/2022
• Device Model Number: 3852
• Device Catalogue Number: 3852
• Device Lot Number: 0026375517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1