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 12/16/2019

Event Type  malfunction  

Event Description

It was reported that balloon rupture occurred.The target lesion was located in the mildly tortuous and moderately calcified artery.The 10mm x 2.75mm wolverine coronary cutting balloon was advanced.However, the balloon ruptured at 6 atmospheres upon the first inflation.The device was removed and the procedure completed with another of same device.No complications were reported and patient the condition was good post procedure.

Manufacturer Narrative

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 an encore inflation unit and positive pressure was applied in an attempt to inflate the balloon.The balloon could not be inflated due to the presence of solidified media and blood that was present within the inflation lumen.The device was soaked in a water bath at a temperature of 37 degrees celsius to help soften the media before further inflation attempts were made.The device was removed from the bath and the balloon was again attached to an inflation device subjected to positive pressure and liquid was observed to be leaking from a balloon pinhole 4mm proximal of distal markerband.An examination of the balloon material and distal markerband identified no issues which could potentially have contributed to this complaint.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 no issues.No other issues were identified during the product analysis.

Event Description

It was reported that balloon rupture occurred.The target lesion was located in the mildly tortuous and moderately calcified artery.The 10mm x 2.75mm wolverine coronary cutting balloon was advanced.However, the balloon ruptured at 6 atmospheres upon the first inflation.The device was removed and the procedure completed with another of same device.No complications were reported and patient the 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: 9527497
• MDR Text Key: 177143449
• Report Number: 2134265-2019-16236
• 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: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/21/2021
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0024309164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2020
• Initial Date Manufacturer Received: 12/16/2019
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: 01/30/2020
• Supplement Dates FDA Received: 02/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1