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 Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the blade was exposed.A 15mmx3.00mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the blade was defective and exposed.No patient complications reported.
Event or Problem Description
It was reported that the blade was exposed.A 15mmx3.00mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the blade was defective and exposed.No patient complications reported.
Additional Manufacturer Narrative
The wolverine cb mr, us 15mmx3.00mmwas returned for analysis.A visual and microscopic examination identified that the balloon was returned in a deflated state.The balloon had been subjected to positive pressure.Three blades were present on the balloon surface.Approximately 4mm of a proximal section of one blade was lifted but not detached; part of the pad was also lifted (approximately 1mm at the site of the lifted blade.No damage was observed to the remaining blades.A visual and tactile examination found no kinks present along the hypotube.A visual and tactile examination found no damage along the shaft polymer extrusion.No issues were noted with the tip of the device.A visual and microscopic examination found no issue with the marker bands.The balloon was inflated to its rated burst pressure of 12 atmospheres with no leaks noted.

• Brand Name: WOLVERINE CORONARY CUTTING BALLOON
• Common Device Name: CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16273907
• Report Number: 2124215-2023-02475
• Device Sequence Number: 15326582
• Product Code: NWX
• UDI-Device Identifier: 08714729888352
• UDI-Public: 08714729888352
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2023

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: 07/20/2024
• Device Model Number: 3855
• Device Catalogue Number: 3855
• Device Lot Number: 0029810159
• 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: 01/12/2023
• Supplement Date Received by Manufacturer: 02/10/2023
• Initial Report FDA Received Date: 01/31/2023
• Supplement Report FDA Received Date: 02/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2022
• 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