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); Detachment of Device or Device Component (2907)

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

Event Date 12/20/2023

Event Type  Injury  

Event Description

It was reported that the balloon detached and used snare to remove the device.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified proximal popliteal artery.A 4.0mm x 15mm wolverine peripheral cutting balloon was selected for use.During the procedure, a diffused lesion was noted throughout the superficial femoral artery which made the delivery impossible.An attempt was made but part of the balloon got stuck and trapped the device midway.Subsequently, when trying to remove the device, the shaft got separated.A snare was used to remove the fragment inside the patient.The device was completely removed, and the procedure was completed with a different device.No complications were reported, and patient was good post procedure.

Event Description

It was reported that the balloon detached and used snare to remove the device.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified proximal popliteal artery.A 4.0mm x 15mm wolverine peripheral cutting balloon was selected for use.During the procedure, a diffused lesion was noted throughout the superficial femoral artery which made the delivery impossible.An attempt was made but part of the balloon got stuck and trapped the device midway.Subsequently, when trying to remove the device, the shaft got separated.A snare was used to remove the fragment inside the patient.The device was completely removed, and the procedure was completed with a different device.No complications were reported, and patient was good post procedure.It was further reported that there was a lesion in popliteal that was attempted to be applied by the device but, a diffuse calcified lesion was found throughout the superficial femoral artery (sfa) and the device was trapped around mid-sfa.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The recommended sheath size as per wolverine ifu for this device is a minimum 6fr.The investigator applied a vacuum and successfully advanced the device through a boston scientific 6fr customers sheath successfully and withdrew the device without any resistance issues or damage to the sheath noted.No issues were noted that could have contributed to the complaint incident.A visual examination of the balloon found no issues with the balloon material, however there was an inner shaft kink noted.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.A visual and tactile examination of the midshaft found it to be detached 250mm proximal from the distal tip.Multiple midshaft kinks were also noted.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18450329
• MDR Text Key: 332171663
• Report Number: 2124215-2023-74534
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/19/2024

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: 0032420558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2023
• Initial Date FDA Received: 01/05/2024
• Supplement Dates Manufacturer Received: 01/23/2024
• Supplement Dates FDA Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2023
• 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 - GLADIUS; GUIDEWIRE - GLADIUS; INTRODUCER SHEATH - 6FR PARENT; INTRODUCER SHEATH - 6FR PARENT
• Patient Outcome(s): Required Intervention