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 Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/07/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter address 1: (b)(6).

Event Description

It was reported that a balloon rupture occurred.A 15mmx2.50mm wolverine coronary cutting balloon was selected for use.During procedure, at second inflation, it was noted that the balloon ruptured at 10atm.The device was removed from the patient's body and the procedure was completed with another of same device.No patient complications were reported and patient's condition was good post procedure.

Manufacturer Narrative

E1 - initial reporter address 1: (b)(6).Device evaluated by mfr: the device was returned for evaluation.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The returned device was attached to an encore inflation unit and positive pressure was applied in an attempt to inflate the balloon and liquid was observed to be leaking from a balloon pinhole located in the middle section of the balloon between both marker bands.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.The rated burst pressure for this device is 12 atmospheres.All blades were intact within their pads and fully bonded to the balloon material.A visual and tactile examination found multiple hypotube kinks along the length of the device.The markerbands and tip and of the device were visually and microscopically examined, and no issues were noted with the device that may have potentially contributed to the complaint incident.No other issues were identified during the product analysis.

Event Description

It was reported that a balloon rupture occurred.A 15mmx2.50mm wolverine coronary cutting balloon was selected for use.During procedure, at second inflation, it was noted that the balloon ruptured at 10atm.The device was removed from the patient's body and the procedure was completed with another of same device.No patient complications were reported and patient's condition was good post procedure.

• 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: 11003182
• MDR Text Key: 221275553
• Report Number: 2134265-2020-17629
• 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: 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2022
• Device Model Number: 3852
• Device Catalogue Number: 3852
• Device Lot Number: 0026186603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Date Manufacturer Received: 01/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1