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

Model Number 3852

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 the balloon ruptured.The 90% stenosed target lesion area was located in a severely tortuous and severely calcified proximal right coronary artery.A 15mmx3.00mm wolverine coronary cutting balloon was selected for use in a percutaneous coronary intervention.During the procedure, the device was advanced for dilatation.However, during the sixth inflation at 12 atmospheres for 15 seconds, the balloon ruptured.The device was simply removed and the procedure was completed with a different device.There were no patient complications reported.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.A visual examination identified that the balloon was returned in a deflated state.The balloon had been subjected to positive pressure.3 blades were present on the balloon surface however the following blade damage was noted: blade 1 - a 3mm section of blade was found to be missing on the distal blade segment.The pad remained attached and secure to the balloon material.Blade 2 - a 1.5 mm section of blade was found to be missing from the mid blade segment - the pad remained attached and secure to the balloon material.Blade 03 - the blade was intact in the pad and the pad was secured to balloon surface, but areas of lift were noted with t-slots exposed along the length of the blade.A visual and tactile examination found no issues with the shaft of this device.An examination of the tip identified that the tip was stretched.A visual and microscopic examination found no issue with the marker bands.The device was attached to an encore inflation unit and during an attempt to inflate the balloon a pinhole leak was identified.The pinhole leak was located at 1mm distal from the distal marker band.

Event Description

It was reported that the balloon ruptured.The 90% stenosed target lesion area was located in the severely tortuous and severely calcified proximal right coronary artery.A 15mmx3.00mm wolverine coronary cutting balloon was selected for use in a percutaneous coronary intervention.During the procedure, the balloon was inflated 6 times at 12 atmospheres for 15 seconds.However, the balloon ruptured.The device was simply removed and the procedure was completed with a different device.There were no patient complications reported.

• 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: 11123076
• MDR Text Key: 225285455
• Report Number: 2134265-2020-18534
• 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: 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/09/2022
• Device Model Number: 3852
• Device Catalogue Number: 3852
• Device Lot Number: 0026329907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2021
• Date Manufacturer Received: 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1