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); Failure to Advance (2524); Material Deformation (2976)

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

Event Date 03/01/2023

Event Type  malfunction  

Event Description

It was reported that a shaft separation occurred.The 95% stenosed target lesion was located in the severely tortuous and calcified below the knee vessel.A 2.5mm x 15mm wolverine peripheral cutting balloon was selected for use.During the procedure, the device was unable to cross the lesion, and it got kinked when it was pushed.Subsequently, when the device was removed with resistance while fixing the kink, the catheter got separated outside the body.The procedure was completed with a different device.There were no patient complications reported post procedure.

Event Description

It was reported that a shaft separation occurred.The 95% stenosed target lesion was located in the severely tortuous and calcified below the knee vessel.A 2.5mm x 15mm wolverine peripheral cutting balloon was selected for use.During the procedure, the device was unable to cross the lesion, and it got kinked when it was pushed.Subsequently, when the device was removed with resistance while fixing the kink, the catheter got separated outside the body.The procedure was completed with a different device.There were no patient complications reported post procedure.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The device was received in two sections due to a detachment of the hypotube.A visual examination identified that the balloon was tightly folded which indicates that the device was not subjected to positive pressure.An examination of the balloon material identified no issues.A visual and tactile examination found the hypotube to be completely detached at approximately 540mm distal of the strain relief.The hypotube was also found to be kinked at more than one location.This type of damage is consistent with excessive force being applied to the device.A visual investigation identified no damage or any issues with the markerbands or tip of the device.

• 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: 16523503
• MDR Text Key: 311084008
• Report Number: 2124215-2023-10978
• 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,Followup
• Report Date: 04/21/2023

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: Health Professional
• Device Model Number: 39345-251510
• Device Catalogue Number: 39345-251510
• Device Lot Number: 0030504006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/02/2023
• Initial Date FDA Received: 03/10/2023
• Supplement Dates Manufacturer Received: 03/28/2023
• Supplement Dates FDA Received: 04/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2022
• 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