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

Model Number 3852

Device Problems Difficult to Insert (1316); Material Rupture (1546); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/26/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter city: (b)(4).

Event Description

It was reported that a balloon rupture occurred.The stenosed target lesion was located in moderately tortuous and moderately calcified vein.A 15mmx4.00mm wolverine coronary cutting balloon was selected for use.During removal of the balloon protector, it was noted that the proximal part of the balloon was inflated.The physician attempted to insert the device into the guiding catheter with care, but there was a resistance and it could not be inserted and the device would not reach to the vessel.Consequently, the balloon was removed by simply pulling out from the guide catheter and when pressure was applied outside patient's body, the balloon ruptured.The procedure was completed with a different device.There were no patient complications reported and the patient condition post procedure was good.

Manufacturer Narrative

E1 - initial reporter city: (b)(6).Device evaluated by mfr: the device was returned for analysis.A visual examination identified that the balloon wings were tightly wrapped.Blood was evident within the balloon folds.The proximal balloon folds had air entrapped.An encore inflation device was attached, and negative pressure applied.Functional testing completed, the device was successfully loaded over a 0.014 inch guidewire with no issue, a vacuum was then pulled, and the device was passed through the 6f guide catheter.The device was attached to an inflation device, subjected to positive pressure and liquid was observed to be leaking from a balloon pinhole located at approximately 1 mm distal from the proximal marker band.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.No issues were noted with the tip section of the device.A visual and microscopic examination found no issue with the marker bands.A visual and tactile examination found no damage or issues with shaft of the device.

Event Description

It was reported that a balloon rupture occurred.The stenosed target lesion was located in moderately tortuous and moderately calcified vein.A 15mmx4.00mm wolverine coronary cutting balloon was selected for use.During removal of the balloon protector, it was noted that the proximal part of the balloon was inflated.The physician attempted to insert the device into the guiding catheter with care, but there was a resistance and it could not be inserted and the device would not reach to the vessel.Consequently, the balloon was removed by simply pulling out from the guide catheter and when pressure was applied outside patient's body, the balloon ruptured.The procedure was completed with a different device.There were no patient complications reported and the patient condition post procedure was good.

• 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: 11496911
• MDR Text Key: 240117858
• Report Number: 2134265-2021-03281
• 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
• Report Date: 04/19/2021

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: 03/06/2022
• Device Model Number: 3852
• Device Catalogue Number: 3852
• Device Lot Number: 0025317571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Initial Date Manufacturer Received: 02/26/2021
• Initial Date FDA Received: 03/16/2021
• Supplement Dates Manufacturer Received: 04/01/2021
• Supplement Dates FDA Received: 04/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1