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 11/08/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that a balloon rupture occurred.A 10mm x 225mm wolverine cutting balloon was advanced for dilatation and on the second inflation, the balloon ruptured at 12atm.The device removed and the procedure completed with a different device.There were no complications and the patient's condition was good post procedure.

Manufacturer Narrative

(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.The returned device was attached to a boston scientific encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole located approximately 1mm proximal of the proximal markerband.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 identified multiple kinks on the hypotube of the device.This type of damage is consistent with excessive force being applied to the device.No other issues were identified during the product analysis.

Event Description

It was reported that a balloon rupture occurred.A 10mm x 225mm wolverine cutting balloon was advanced for dilatation and on the second inflation, the balloon ruptured at 12atm.The device removed and the procedure completed with a different device.There were no complications and the 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: 9359283
• MDR Text Key: 173513932
• Report Number: 2134265-2019-14292
• 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: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0023986188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2019
• Date Manufacturer Received: 12/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1