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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The 90% stenosed target lesion was located in the mildly tortuous and moderately calcified proximal right coronary artery.A 15mm x 3.50mm wolverine coronary cutting balloon was selected for use.During procedure, the wolverine coronary cutting balloon was advanced onto the guidewire but the shaft broke before it entered the hemostasis valve.The break occurred outside the patient body.The device was simply pulled out.The procedure was completed with a different device.No patient complications were reported.
Event or Problem Description
It was reported that shaft break occurred.The 90% stenosed target lesion was located in the mildly tortuous and moderately calcified proximal right coronary artery.A 15mm x 3.50mm wolverine coronary cutting balloon was selected for use.During the procedure, the wolverine coronary cutting balloon was advanced onto the guidewire but the shaft broke before it entered the hemostasis valve.The break occurred outside the patient body.The device was simply pulled out.The procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Balloon, blades and pads: a visual examination identified that the balloon wings were found to be wrapped.There were no issues noted with the balloon material.All blades were securely bonded and no damage to the blades were noted.No issues were noted with the tip section of the device.A visual and microscopic examination found no issue with the marker bands.A visual and tactile examination was completed on the shaft of the device.A hypotube break was identified at approx.80.4 cm distal from the strain relief.The portion of the hypotube distal from the break point had multiple kinks present.Shaft polymer extrusion: a visual and tactile examination was completed, and no issues were 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
• MDR Report Key: 11845276
• Report Number: 2134265-2021-06446
• Device Sequence Number: 19689342
• Product Code: NWX
• UDI-Device Identifier: 08714729888376
• UDI-Public: 08714729888376
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2021

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: 10/30/2022
• Device Model Number: 3855
• Device Catalogue Number: 3855
• Device Lot Number: 0026278240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2021
• Initial Date Received by Manufacturer: 04/28/2021
• Supplement Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 06/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE- PROWATER; GUIDEWIRE- PROWATER