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 10/11/2023

Event Type  malfunction  

Event Description

It was reported that the device was fractured.The target lesion was located in the moderately tortuous and moderately calcified artery.A 10mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, upon introduction of the device, it was noted that the device was fractured.The device was removed intact.The procedure was completed with a different device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.A visual examination of the balloon identified no damages.A hypotube break was identified, 78.5cm distal to the distal end of the strain relief and multiple hypotube kinks were noted along the shaft of the device.The shaft polymer extrusion has no kinks or damages.A detailed microscopic examination of the balloon material identified no tears or pinholes in the balloon.All blades were fully bonded on the balloon and did not exhibit any signs of damage.No issues identified during examination of the extrusion shaft.Tip showed no signs of tip damage.The proximal and distal markerbands identified no damage.

Event Description

It was reported that the device was fractured.The target lesion was located in the moderately tortuous and moderately calcified artery.A 10mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, upon introduction of the device, it was noted that the device was fractured.The device was removed intact.The procedure was completed with a different device.No patient complications were reported.

• 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: 17996693
• MDR Text Key: 326394543
• Report Number: 2124215-2023-58960
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 11/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3854
• Device Catalogue Number: 3854
• Device Lot Number: 0029769459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2022
• 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