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 Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/22/2020

Event Type  malfunction  

Event Description

It was reported that a balloon rupture occurred.A 10mmx2.75mm wolverine coronary cutting balloon was selected for use.During procedure, at first inflation, it was noted that the balloon ruptured.The procedure was completed with another of same device.No patient complications were reported.

Event Description

It was reported that a balloon rupture occurred.A 10mmx2.75mm wolverine coronary cutting balloon was selected for use.During procedure, at first inflation, it was noted that the balloon ruptured.The procedure was completed with another of same device.No patient complications were reported.It was further reported that the device was simply removed from the patient's body.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for evaluation.No kinks were noted along the length of the shaft.There was solidified blood visible in the inflation lumen.This blood is consistent with a leak having occurred in the device.The device was soaked in a water bath at 37 degrees celsius in order to soften the blood to accommodate balloon inflation.A visual examination identified that the balloon wings were folded.There were no issues noted with the balloon material.The device was attached to an encore inflation unit and during an attempt to inflate the balloon, a pinhole leak was confirmed in the balloon material.The pinhole was located in the proximal transition zone in the balloon material.An examination of the pinhole site identified no issues with the balloon which could potentially have contributed to the pinhole leak.All blades were securely bonded and no damage to the blades were noted.No issues were noted with the tip section of the device.A visual and microscopic examination found no issue with the marker bands.No other damage was present.

Event Description

It was reported that a balloon rupture occurred.A 10mmx2.75mm wolverine coronary cutting balloon was selected for use.During procedure, at first inflation, it was noted that the balloon ruptured.The procedure was completed with another of same device.No patient complications were reported.It was further reported that the device was simply removed from the patient's body.

• 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: 11073190
• MDR Text Key: 223796683
• Report Number: 2134265-2020-18476
• 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,Followup
• Report Date: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/26/2022
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0026083807
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2021
• Date Manufacturer Received: 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1