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 Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/13/2024

Event Type  Injury  

Event Description

It was reported that a blade detached and remained in the patient's body.The 99% stenosed target lesion was located in the moderately tortuous and moderately calcified superficial femoral artery (sfa).A 4.0mm x 15mm wolverine peripheral cutting balloon was selected for use.During the procedure, the blade was damaged, and it is possible that a blade part was left in the lesion area.Since it was suspected that the fragment might have been embedded in the lesion, an eluvia 7 mm was placed at the site and the procedure was completed.No patient complications were reported.

Event Description

It was reported that a blade detached and remained in the patient's body.The 99% stenosed target lesion was located in the moderately tortuous and moderately calcified superficial femoral artery (sfa).A 4.0mm x 15mm wolverine peripheral cutting balloon was selected for use.During the procedure, the blade was damaged, and it is possible that a blade part was left in the lesion area.Since it was suspected that the fragment might have been embedded in the lesion, an eluvia 7 mm was placed at the site and the procedure was completed.No patient complications were reported.It was further reported that, the lesion was dilated multiple times at rated pressure, and there was strong resistance when removing from the lesion, but it was managed to be pulled out.

Manufacturer Narrative

Device evaluated by mfr.: the device was returned for analysis.A visual examination of the returned device identified that the balloon had been inflated and was not refolded.It is not known when the balloon was subjected to positive pressure.A visual examination of the returned device identified that approximately 5mm of two blades were noted to have lifted and partially detached from the pad material.The blade pad was fully bonded to the balloon material.The other remaining 2 blades were fully bonded to the pad and balloon material.No issues were noted with the tip section of the device.A visual examination found no issue with the markerbands.A visual and tactile examination identified no kinks or damage to the shaft of the returned 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19029866
• MDR Text Key: 339205479
• Report Number: 2124215-2024-19883
• 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: 05/10/2024

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: 0032576534
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2024
• Initial Date FDA Received: 04/02/2024
• Supplement Dates Manufacturer Received: 04/18/2024
• Supplement Dates FDA Received: 05/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2023
• 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
• Patient Outcome(s): Required Intervention