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 Material Puncture/Hole (1504); Material Deformation (2976)

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

Event Date 02/26/2024

Event Type  malfunction  

Event Description

It was reported that a shaft hole occurred.The 70% stenosed target lesion was located in the moderately tortuous and severely calcified right coronary artery (rca).A 10mmx2.50mm wolverine cutting balloon was selected for percutaneous coronary intervention (pci).During advancement of the wolverine some resistance was noted, and the shaft became kinked when attempting to cross the lesion.A shaft hole was also noted.The balloon was removed from the patient's body without any problem using the normal method and the procedure was completed with another of the same device.No patient injury was reported, and the patient was stable after the procedure.

Event Description

It was reported that a shaft hole occurred.The 70% stenosed target lesion was located in the moderately tortuous and severely calcified right coronary artery (rca).A 10mmx2.50mm wolverine cutting balloon was selected for percutaneous coronary intervention (pci).During advancement of the wolverine some resistance was noted, and the shaft became kinked when attempting to cross the lesion.A shaft hole was also noted.The balloon was removed from the patient's body without any problem using the normal method and the procedure was completed with another of the same device.No patient injury was reported, and the patient was stable after the procedure.It was further reported that the balloon was inflated at 8 atm when it leaked in the shaft.

• 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: 19101414
• MDR Text Key: 340455240
• Report Number: 2124215-2024-20926
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/25/2024

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 Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0032493459
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2024
• Initial Date FDA Received: 04/12/2024
• Supplement Dates Manufacturer Received: 04/04/2024
• Supplement Dates FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2023
• 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