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	02/04/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a shaft break occurred.Vascular access was via radial approach.A 15mm x 4.00mm wolverine coronary cutting balloon was selected for use.During preparation, it was noted that shaft broke at the rx lumen only a couple of inches after fully inserted into the co-pilot hemostasis valve.The device was removed with the guide and retrieved without issue.The procedure was completed with another of same device.No adverse events were recorded and no harm came to the patient.
Event or Problem Description
It was reported that a shaft break occurred.Vascular access was via radial approach.A 15mmx4.00mm wolverine coronary cutting balloon was selected for use.During preparation, it was noted that shaft broke at the rx lumen only a couple of inches after fully inserted into the co-pilot hemostasis valve.The device was removed with the guide and retrieved without issue.The procedure was completed with another of same device.No adverse events were recorded and no harm came to the patient.It was further reported that this event was reported via medwatch 2301650000-2021-8003.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.A visual examination identified that the balloon wings were found to be in a deflated state.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 34.2cm distally from the strain relief.Multiple hypotube kinks were also noted on the device.No other issues were noted with the device.
Event or Problem Description
It was reported that a shaft break occurred.Vascular access was via radial approach.A 15mmx4.00mm wolverine coronary cutting balloon was selected for use.During preparation, it was noted that shaft broke at the rx lumen only a couple of inches after fully inserted into the co-pilot hemostasis valve.The device was removed with the guide and retrieved without issue.The procedure was completed with another of same device.No adverse events were recorded and no harm came to the patient.It was further reported that this event was reported via medwatch 2301650000-2021-8003.

• 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: 11365562
• Report Number: 2134265-2021-01764
• Device Sequence Number: 16405621
• Product Code: NWX
• UDI-Device Identifier: 08714729888390
• UDI-Public: 08714729888390
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/12/2021

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: 11/24/2022
• Device Model Number: 3855
• Device Catalogue Number: 3855
• Device Lot Number: 0026417127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2021
• Initial Date Received by Manufacturer: 02/04/2021
• Supplement Date Received by Manufacturer: 02/23/2021; 03/18/2021
• Initial Report FDA Received Date: 02/23/2021
• Supplement Report FDA Received Date: 03/12/2021; 04/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 78