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 Failure to Advance (2524)

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

Event Date 08/22/2022

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 02feb2023.It was reported that the device was not able to cross the lesion.The target lesion was located in the left anterior descending artery.A 10mmx3.00mm wolverine coronary cutting balloon was selected for use.During the procedure, the lesion was engaged with 6f guiding and the proximal to mid segment was crossed with 014 wire.Pre dilatation was done using 2x8mm balloon up to 8 atm.Wolverine was then taken since it is fibro calcified lesion however, the device was not able to cross the lesion.Another plaque modification technology was used to prepare the lesion site for stenting.Procedure was completed successfully.No patient complications were reported.However, device analysis revealed that a complete shaft break occurred.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for evaluation.The device was returned in two pieces there was a complete shaft break present at 9 cm distal the end of the strain relief.A visual examination identified that the balloon folds were in a wrapped state and had not been subject to positive pressure.There were no issues noted with the balloon material.All blades were securely bonded and no damage to the blades were noted.All blades were intact within their pads and fully bonded to the balloon material.A visual and tactile examination of the hypotube identified a shaft break at approximately 9cm distal to the distal end of the strain relief.The markerbands and tip and 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.No other issues were identified during the product analysis.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16387591
• MDR Text Key: 309675948
• Report Number: 2124215-2023-06244
• 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: 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/24/2024
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0029113232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BALLOON: NC BALLOON