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

Model Number 3851

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/27/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that balloon rupture occurred.A 10mmx3.50mm wolverine coronary cutting balloon was selected for use.During procedure, it was noted that the balloon ruptured upon third inflation at nominal pressure.The device was simply pulled out from the patient's body.The procedure was completed with the original device.No patient complications were reported.

Event Description

It was reported that balloon rupture occurred.A 10mmx3.50mm wolverine coronary cutting balloon was selected for use.During procedure, it was noted that the balloon ruptured upon third inflation at nominal pressure.The device was simply pulled out from the patient's body.The procedure was completed with the original device.No patient complications were reported.

Manufacturer Narrative

E1: initial reporter facility name - (b)(6) medical center.E1: initial reporter address 1 - (b)(6).Device evaluated by manufacturer: the device was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.An examination of the balloon material identified no tears in the balloon.The returned device was attached to an encore inflation unit and during an attempt to inflate the balloon, a pinhole leak was confirmed.The pinhole was located approximately 3 mm distal to the proximal marker band.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 as per wolverine label specification.All blades were intact within their pads and fully bonded to the balloon material.A visual and tactile examination found no kinks or damage to the hypotube or shaft 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.

• 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: 10991046
• MDR Text Key: 220912698
• Report Number: 2134265-2020-17394
• 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: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/07/2022
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0026144258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Date Manufacturer Received: 01/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1