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

Model Number 3851

Device Problems Break (1069); Difficult to Advance (2920); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/05/2021

Event Type  malfunction  

Event Description

It was reported that the catheter shaft broke.A percutaneous coronary intervention was being performed.The 70% stenosed target lesion was located in the severely tortuous and severely calcified left circumflex artery.During the procedure, when a 10mmx3.50mm wolverine coronary cutting balloon was inserted into the guide, the clinician noted that there was a lot of resistance advancing the wolverine up through the guide catheter.The clinician then removed the guidewire that was previously placed in the left anterior descending artery (lad) and he could then advance the wolverine to the secondary curvature of the guide, however the force to advance bent the hypotube of the wolverine at about 15cm from the hub.The wolverine was removed by pulling out; however during removal, the hypotube snapped at the point of the bend.The procedure was completed with a different device.No patient complications were reported.

Event Description

It was reported that the catheter shaft broke.The 70% stenosed target lesion was located in the severely tortuous and severely calcified left circumflex artery.During the procedure, when a 10mmx3.50mm wolverine coronary cutting balloon was inserted into the guide, the clinician noted that there was a lot of resistance advancing the wolverine up through the guide catheter.The clinician then removed the guidewire that was previously placed in the left anterior descending artery (lad) and he could then advance the wolverine to the secondary curvature of the guide, however the force to advance bent the hypotube of the wolverine at about 15cm from the hub.The wolverine was removed by pulling out; however during removal, the hypotube snapped at the point of the bend.The procedure was completed with a different device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr: a 10mmx3.50mm wolverine cutting balloon was returned for analysis.A visual examination identified that the balloon wings were found to be in a wrapped 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 which identified multiple hypotube kinks.A complete hypotube break was noted 26.1 cm distal to the strain relief.A visual and tactile examination was completed, no issues were noted with the shaft polymer extrusion of this device.

• Brand Name: WOLVERINE CORONARY CUTTING BALLOON MONORAIL
• Type of Device: 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12821937
• MDR Text Key: 280951317
• Report Number: 2134265-2021-14396
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/07/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 02/19/2023
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0026838302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/05/2021
• Initial Date FDA Received: 11/16/2021
• Supplement Dates Manufacturer Received: 12/21/2021
• Supplement Dates FDA Received: 01/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1