MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WOLVERINE PERIPHERAL CUTTING BALLOON; Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring

Model Number 39345-401510

Device Problems Difficult to Remove (1528); Material Rupture (1546); Failure to Deflate (4060)

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

Event Date 02/09/2023

Event Type  malfunction  

Event Description

It was reported that a balloon rupture occurred.The 95% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.A 4.0mm x 15mm wolverine peripheral cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured upon second inflation at 6atm within 30 seconds.The balloon was not completely deflated, and resistance was felt when it was removed.The device was removed together with the sheath since the balloon was difficult to recapture into the sheath.In addition, a blood leak occurred and was treated with compression and sheath replacement insertion.The procedure was completed with a different device.There were no patient complications reported post procedure.

• Brand Name: WOLVERINE PERIPHERAL CUTTING BALLOON
• 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: 16446750
• MDR Text Key: 310337228
• Report Number: 2124215-2023-07748
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 39345-401510
• Device Catalogue Number: 39345-401510
• Device Lot Number: 0030810855
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2023
• 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