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	Break (1069); Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/09/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter shaft broke.The target lesion was located in the mild to moderately calcified left anterior descending artery.A 15mmx3.50mm wolverine coronary cutting balloon was selected for use.During the procedure, when the device was introduced, it was noted that it would not pass the curve of the guide catheter.The device, while inside the guide catheter, was simply removed from the patient's body.Then, as the device inside the guide catheter was manipulated on the back table, it was noted that the shaft was broken in two pieces.Furthermore, it was also noted that the device became kinked while inside the guide catheter.The device was removed from the guide catheter after manipulating on the back table and the procedure was completed with a different device.No complications were reported and the patient was fine post procedure.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.The device was received in two sections as the result of a break in the hypotube.A visual and tactile examination identified a complete break of the hypotube located approximately 300mm distal of the strain relief.The hypotube was also noted to be kinked at more than one location along its length.This type of damage is consistent with excessive force being applied to the delivery system.No other issues were noted with the hypotube that may have contributed to the complaint incident.An examination of the returned device identified that the balloon had not been inflated.No issues were identified with the balloon which could potentially have contributed to this complaint.A visual and microscopic examination identified no damage to the markerbands or blades of the device.All blades were present and fully bonded to the balloon material.A microscopic examination identified damage to the tip of the device.This type of damage is consistent with excessive tensile force being applied to the device possibly when removing the packaging mandrel.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that the catheter shaft broke.The target lesion was located in the mild to moderately calcified left anterior descending artery.A 15mmx3.50mm wolverine coronary cutting balloon was selected for use.During the procedure, when the device was introduced, it was noted that it would not pass the curve of the guide catheter.The device, while inside the guide catheter, was simply removed from the patient's body.Then, as the device inside the guide catheter was manipulated on the back table, it was noted that the shaft was broken in two pieces.Furthermore, it was also noted that the device became kinked while inside the guide catheter.The device was removed from the guide catheter after manipulating on the back table and the procedure was completed with a different device.No complications were reported and the patient was fine 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; two scimed place; maple grove MN 55311
• MDR Report Key: 9898071
• Report Number: 2134265-2020-03974
• Device Sequence Number: 19436955
• Product Code: NWX
• UDI-Device Identifier: 08714729888376
• UDI-Public: 08714729888376
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P950020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2020

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: 01/20/2022
• Device Model Number: 3855
• Device Catalogue Number: 3855
• Device Lot Number: 0025074241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2020
• Initial Date Received by Manufacturer: 03/09/2020
• Supplement Date Received by Manufacturer: 04/20/2020
• Initial Report FDA Received Date: 03/30/2020
• Supplement Report FDA Received Date: 05/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR