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 12/12/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that the balloon ruptured.During a procedure involving a 10mm x 2.50mm was wolverine coronary cutting balloon, it was noted that a balloon rupture occurred.The procedure was completed with another of the same device.

Manufacturer Narrative

E1.Initial reporter facility name: (b)(6) hospital.

Event Description

It was reported that the balloon ruptured.During a procedure involving a 10mm x 2.50mm was wolverine coronary cutting balloon, it was noted that a balloon rupture occurred.The procedure was completed with another of the same device.It was further reported that the balloon was simply pulled out of the patient's body and that the patient was good post procedure.

Manufacturer Narrative

E1.Initial reporter facility name: (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.Blood was in balloon which is indicative of a device leak.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 tear in the shaft polymer extrusion at the guidewire exit port.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 specification.The markerbands, blades and tip section 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.All blades were present and fully bonded to the balloon material.A visual and tactile examination of the shaft/hypotube identified a leak at the guidewire exit port.The shaft polymer extrusion was torn at the leak site 1mm distal of the guidewire exit port.The guidewire exit port bond was also stretched by 4 mm and multiple hypotube kinks were identified.

Event Description

It was reported that the balloon ruptured.During a procedure involving a 10mm x 2.50mm was wolverine coronary cutting balloon, it was noted that a balloon rupture occurred.The procedure was completed with another of the same device.It was further reported that the balloon was simply pulled out of the patient's body and that the patient 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: 9521401
• MDR Text Key: 177128855
• Report Number: 2134265-2019-16189
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/07/2021
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0024394196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2020
• Date Manufacturer Received: 02/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1