MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING

Model Number	3855
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon was difficult to remove and almost detached from the shaft and the guidewires were partially detached.The target lesion was located in the left anterior descending artery.The balloon was inflated for multiple inflations at 14 to 16 atm for 12 to 14 seconds.A 15mmx3.00mm wolverine coronary cutting balloon was selected for use.Upon removal, the wolverine balloon would not come back through the choice pt floppy guidewire upon deflation.The physician tried to pull double negative and took an empty 20cc syringe and pulled negative.Neither of these techniques worked.The physician then inflated the wolverine to 2 atm and deflated but it still would not come through to the guidewire.The physician then placed another choice pt floppy guidewire next to the wolverine with a 2.5mmx 12mm emerge balloon catheter onto the wire.Physician inflated next to the wolverine and was finally able to nudge the balloon enough to fully retract it out of the body.Physician said it was still very difficult to retract.Upon investigation, it was noted that the two wires were both frayed and partially detached and the wolverine seemed to almost be detached from the shaft.The device was removed as one unit together with the guidewire, and procedure was completed using another device.No further complications were reported, and patient is stable post procedure.

• Brand Name: WOLVERINE CORONARY CUTTING BALLOON
• Common Device Name: 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 CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19618602
• Report Number: 2124215-2024-38976
• Device Sequence Number: 17881164
• Product Code: NWX
• UDI-Device Identifier: 08714729888352
• UDI-Public: 08714729888352
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P950020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/26/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/18/2026
• Device Model Number: 3855
• Device Catalogue Number: 3855
• Device Lot Number: 0033249952
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2024
• Initial Report FDA Received Date: 06/26/2024
• Date Device Manufactured: 01/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male