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 Break (1069); Material Deformation (2976)

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

Event Date 02/17/2023

Event Type  Injury  

Event Description

It was reported that the balloon became separated from the catheter and was snared to remove.The 100% stenosed target lesion was located in the mildly tortuous and moderately calcified superficial femoral artery.A 4.0mmx15mm wolverine peripheral cutting balloon was selected for use.During the procedure, it was noted that the balloon became separated from the catheter at the mid-superficial femoral artery.As per physician's opinion, the balloon section was trapped in the calcified area and there was a lesion on the exit port of the mr lumen that caused the kink and separation of the device when it was pulled out.The separated fragments of the device were successfully caught and removed by an en snare, and the procedure was completed with a different device.No complications were reported, and the patient was in good progress after surgery.

Manufacturer Narrative

Device evaluated by mfr: the complaint device was received for product analysis.The device was received in two sections due to a complete separation of the shaft polymer extrusion.A visual examination identified that the shaft was severely kinked at more than one location.The shaft was also completely separated at the monorail port.The inner shaft of the distal device section was also found to have been pulled in a proximal direction causing the balloon and tip to invert inside the balloon and move both markerbands proximally.This type of damage is consistent with the user kinking the shaft when treating the lesion and then applying excessive tensile force to remove the device from the patient, causing device separation and the inner shaft to move proximally.The investigator was unable to pull the tip and inner shaft back in a distal direction.No other issues were identified with the shaft of the device.A visual examination found no issues or damage to the balloon, blades, markerbands.The balloon had been inflated.The tip of the device could not be analysed as it had been pulled proximally inside the balloon material and could not be removed.This concludes the product analysis.

Event Description

It was reported that the balloon became separated from the catheter and was snared to remove.The 100% stenosed target lesion was located in the mildly tortuous and moderately calcified superficial femoral artery.A 4.0mmx15mm wolverine peripheral cutting balloon was selected for use.During the procedure, it was noted that the balloon became separated from the catheter at the mid-superficial femoral artery.As per physician's opinion, the balloon section was trapped in the calcified area and there was a lesion on the exit port of the mr lumen that caused the kink and separation of the device when it was pulled out.The separated fragments of the device were successfully caught and removed by an en snare, and the procedure was completed with a different device.No complications were reported, and the patient was in good progress after surgery.

• 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: 16512728
• MDR Text Key: 310970667
• Report Number: 2124215-2023-10239
• 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: 04/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 39345-401510
• Device Catalogue Number: 39345-401510
• Device Lot Number: 0030826717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2023
• Initial Date FDA Received: 03/09/2023
• Supplement Dates Manufacturer Received: 03/23/2023
• Supplement Dates FDA Received: 04/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2023
• 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 - BOSTON JUPITER FC3; GUIDEWIRE - BOSTON JUPITER FC3; INTRODUCER SHEATH - NIPRO CROSSROAD 6F; INTRODUCER SHEATH - NIPRO CROSSROAD 6F
• Patient Outcome(s): Required Intervention