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

Model Number 3850

Device Problems Failure to Advance (2524); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 01/20/2023

Event Type  malfunction  

Manufacturer Narrative

Device analysis by mfr: the returned product consists of the wolverine cb mr, ous 6mm x 3.50mm device.A visual and microscopic examination identified that the balloon was returned in a deflated state.The balloon had been subjected to positive pressure.All four blades were present on the balloon surface however the distal edge of one of the blade segments was slightly raised.The pad was fully intact.No damage was observed to the remaining blades.A visual and tactile examination found no kinks present along the hypotube.A visual and tactile examination found a kink existed at the guidewire exit port at 24.1cm from the tip of the balloon.There was a build-up of solidified contrast media present inside the inflation lumen.No issues were noted with the tip of the device.A visual and microscopic examination found no issue with the marker bands.

Event Description

It was discovered that a blade was lifted off the balloon.A wolverine cb mr, ous 6mm x 3.50mm ballon was being used to treat an 80% stenosed, severely calcified, severely tortuous lesion.While advancing the balloon, resistance was met due to the severe tortuosity and calcification and the balloon was unable to be advanced to the target lesion.The balloon was removedfrom the patient, and another balloon was used to complete the procedure successfully with no patient complications.Upon analysis of the wolverine balloon, it was discovered that one of the blade segments was slightly raised.

• Brand Name: WOLVERINE CORONARY CUTTING BALLOON MONORAIL
• Type of Device: CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 17138736
• MDR Text Key: 317273923
• Report Number: 2124215-2023-30956
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3850
• Device Catalogue Number: 3850
• Device Lot Number: 0030028678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 74 KG