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

Model Number 3851

Device Problems Break (1069); Failure to Advance (2524); Material Deformation (2976)

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

Event Date 08/17/2023

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis.A visual and tactile examination identified that a break had occurred in the hypotube.The break was located at 18.7cm distal to the distal end of the strain relief.An examination of both sections of the break identified multiple kinking along both sections of the hypotube break.No kinks or damages were noted in the polymer shaft.A microscopic examination of the break identified that the break is consistent with a severe kink that had occurred in the hypotube.No issues identified during a microscopic examination of the extrusion shaft.All blades were fully bonded on the balloon and did not exhibit any signs of damage.A detailed microscopic examination of the balloon material identified no damages.The balloon was folded.A microscopic examination of the tip section found no damage.

Event Description

Reportable based on device analysis completed on 11dec2023.It was reported that the balloon failed to cross and was kinked near the hub and hub was broken.The 80% stenosed target lesion was located in the severely tortuous and severely calcified proximal left anterior descending artery (plad).A 10mmx3.50mm wolverine cutting balloon was selected for percutaneous transluminal coronary angioplasty (ptca).During the procedure, wolverine was tried to cross the lesion and it was very tortuous the wolverine couldn't cross.After multiple attempts of trying to cross, the physician found that the balloon got kinked in proximal portion near to hub and got broken also.The physician used another 3.5x10 wolverine to complete the procedure successfully.The procedure was completed with another of the same device.No patient complications were reported.However, device analysis revealed that a break had occurred in the hypotube located at 18.7cm distal to the distal end of the strain relief.

• 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 IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18394271
• MDR Text Key: 331507919
• Report Number: 2124215-2023-73713
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0031036529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2023
• 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
• Patient Sex: Male
• Patient Race: Asian