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

Model Number	3854
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon was difficult to remove from the lesion.The 80% stenosed target lesion was located in the saphenous vein graft.A 10mmx4.00mm wolverine coronary cutting balloon was inflated to the rated burst of 12atm.During the procedure, upon removal, it was noted, that the balloon seemed stuck and was difficult to remove.A slow deflation and a negative pressure were applied.And eventually, the device was removed completely from the patient.The device was observed to be bulky and partially deflated.The procedure was completed.No patient complications were reported.
Additional Manufacturer Narrative
D4 - lot no: 0031017459.
Event or Problem Description
It was reported that the balloon was difficult to remove from the lesion.The 80% stenosed target lesion was located in the saphenous vein graft.A 10mmx4.00mm wolverine coronary cutting balloon was inflated to the rated burst of 12atm.During the procedure, upon removal, it was noted that the balloon seemed stuck and was difficult to remove.A slow deflation and a negative pressure were applied and eventually the device was removed completely from the patient.The device was observed to be bulky and partially deflated.The procedure was completed.No patient complications were reported.
Event or Problem Description
It was reported that the balloon was difficult to remove from the lesion.The 80% stenosed target lesion was located in the saphenous vein graft.A 10mmx4.00mm wolverine coronary cutting balloon was inflated to the rated burst of 12atm.During the procedure, upon removal, it was noted that the balloon seemed stuck and was difficult to remove.A slow deflation and a negative pressure were applied and eventually the device was removed completely from the patient.The device was observed to be bulky and partially deflated.The procedure was completed.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Visual/tactile inspection was performed.A visual and tactile examination identified multiple kinking along the hypotube.No visible damages along the shaft polymer extrusion.A microscopic examination of the distal extrusion identified a jagged tear in the extrusion.The tear stretched from the guidewire port and extended distally for 5mm in length.A detailed microscopic examination of the balloon material identified no tears or pinholes in the balloon.The balloon exhibited signs of having been inflated with some traces of liquid visible in the balloon.A microscopic examination of the blades identified that approximately 2mm of a proximal section of a distal blade segment was detached and was not returned.The remaining blades and all of the blade pads were fully intact.Tip showed no signs of tip damage.A microscopic examination of the proximal and distal markerbands identified no damage.Using an encore inflation unit an attempt was made to inflate the balloon when a leak was confirmed at the site of the damage in the distal extrusion at the guidewire port.A visual tactile, microscopic and leakage test was performed.A visual and tactile examination identified multiple kinking along the hypotube.Device analysis confirmed that a leak was present in the distal extrusion because of a jagged tear in the extrusion at the site of the port.The tear is consistent with the guidewire being pulled from the device which ripped the wire lumen and outer lumen for a length of 5mm.Further microscopic examination of the balloon identified no tears or holes in the balloon material.However, a microscopic examination of the blades identified that approximately 2mm of a proximal section of a distal blade segment was detached and was not returned.The remaining blades and all of the blade pads were fully intact.No other damage was observed.

• 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 IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17174924
• Report Number: 2124215-2023-30091
• Device Sequence Number: 17414821
• Product Code: NWX
• UDI-Device Identifier: 08714729888307
• UDI-Public: 08714729888307
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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,Followup,Followup
• Report Date (Section B): 08/07/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/08/2025
• Device Model Number: 3854
• Device Catalogue Number: 3854
• Device Lot Number: 0031017459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/31/2023
• Supplement Date Received by Manufacturer: 06/21/2023; 07/20/2023
• Initial Report FDA Received Date: 06/21/2023
• Supplement Report FDA Received Date: 07/10/2023; 08/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2023
• 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: Unknown