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

Model Number 39345-251510

Device Problems Break (1069); Difficult to Remove (1528)

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

Event Date 03/25/2024

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.A break at 127cm distal to the distal end of the strain relief at the polymer extrusion was noted.The polymer extrusion was also noted to be stretched.A visual and tactile examination found multiple hypotube kinks.No issues were noted with the balloon material.The markerbands and blades and tip section of the device were visually examined, and no issues were noted with the markerbands, blades or tip of the device.All blades were present and fully bonded to the balloon material.

Event Description

It was reported that the device was separated inside the sheath.The 95% stenosed target lesion was located in the moderately tortuous and severely calcified below the knee artery.A 2.5mm x 15mm peripheral cutting balloon was selected for use.After the lesion was dilated, an attempt was made to remove the device.A slight resistance was felt when trying to pull the device and the device got separated inside the sheath.The device remained in the sheath, so the entire sheath was removed, and the procedure was completed with this device.There were no patient complications reported as a result of this event.

• Brand Name: WOLVERINE PERIPHERAL 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 CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19169454
• MDR Text Key: 341245671
• Report Number: 2124215-2024-22484
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 39345-251510
• Device Catalogue Number: 39345-251510
• Device Lot Number: 0032081919
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2023
• 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
• Treatment: GUIDEWIRE - ASAHI; INTRODUCER SHEATH - 6F MEDIKIT