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

Model Number 39345-401510

Device Problem Material Deformation (2976)

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

Event Date 04/19/2023

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: the device was returned for evaluation.A visual examination identified that the hypotube was severely kinked at more than one location.The hypotube was also completely separated at approximately 650mm distal of the strain relief.This type of damage is consistent with excessive force being applied to the device.No issues were identified with the shaft polymer extrusion of the device.A visual examination found that the balloon had been inflated.No issues or damage was noted to the balloon, blades, markerbands or tip of the device.All blades were present and fully bonded to the balloon material.No other issues were identified during the product analysis.

Event Description

Reportable based on device analysis completed on 29may2023.It was reported that the center part of the shaft got kinked.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified left popliteal artery.A 4.0mm x 15mm wolverine peripheral cutting balloon was selected for use.During the procedure, it was noted that the center part of the shaft got kinked.The procedure was completed with a different device.No patient complications were reported.However, device analysis revealed that a complete separation of the hypotube occurred.

• 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 IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 17122499
• MDR Text Key: 317243063
• Report Number: 2124215-2023-29783
• 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: 06/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2023
• 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: 0030114607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2022
• 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