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

Model Number 3854

Device Problem Break (1069)

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

Event Date 12/15/2023

Event Type  malfunction  

Event Description

It was reported that the device was fractured.The target lesion was located in the mildly tortuous and moderately calcified artery.A 10mmx2.50mm wolverine cutting balloon was selected for use.During the procedure, the balloon was loaded onto a run through and the doctor went to advance through the copilot when the mid shaft got separated.The device was removed from the patient's body successfully and the procedure was completed with a different device.No complications were reported.

Event Description

It was reported that the device was fractured.The target lesion was located in the mildly tortuous and moderately calcified artery.A 10mmx2.50mm wolverine cutting balloon was selected for use.During the procedure, the balloon was loaded onto a run through and the doctor went to advance through the copilot when the mid shaft got separated.The device was removed from the patient's body successfully and the procedure was completed with a different device.No complications were reported.It was further reported that the device was outside of the body at the time of the event and it never entered the body of the patient as this was noted during preparation.Also, the break was roughly 30-40% up the shaft from the balloon.

• Brand Name: WOLVERINE CORONARY CUTTING BALLOON
• 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: 18395174
• MDR Text Key: 331344725
• Report Number: 2124215-2023-73778
• Device Sequence Number: 1
• Product Code: NWX
• UDI-Device Identifier: 08714729888246
• UDI-Public: 08714729888246
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P950020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/18/2024

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: Other
• Device Model Number: 3854
• Device Catalogue Number: 3854
• Device Lot Number: 0031156920
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2023
• Initial Date FDA Received: 12/26/2023
• Supplement Dates Manufacturer Received: 01/04/2024
• Supplement Dates FDA Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2023
• 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