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

Model Number 3851

Device Problem Material Deformation (2976)

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

Event Date 12/16/2022

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 07feb2023.It was reported that a device kinked occurred.The target lesion was located in the left anterior descending artery.A 10mmx3.50mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the device was kinked.The device was removed with the normal method and the procedure was completed with another of the same device.No patient complications reported.However, device investigations revealed a perforation in the outer extrusion at 5.6cm proximal from the tip.

Manufacturer Narrative

Device evaluated by manufacturer: a wolverine cb 10mmx3.50mm, catheter was returned for analysis.Based on the potential hazards/failure modes identified and the complaint report, the following attributes were examined: a visual examination identified that the balloon was folded.A microscopic examination of the balloon material and marker bands identified no issues which could potentially have contributed to this complaint.All blades were intact within their pads and fully bonded to the balloon material.A visual and tactile examination found a kink in the hypotube.The kink was located at 65.5cm distal from the strain relief.An examination of the distal extrusion identified that the distal extrusion was kinked at 9cm; 9.4cm and 10cm distal from the port.A microscopic examination of the inner/wire lumen noted bunching of the extrusion at approximately 5.2cm proximal from the tip.Further examinations noted a perforation in the outer extrusion at 5.6cm proximal from the tip.It is likely that as a result of the bunching in the wire lumen, when an attempt was made by the physician to pass the wire through the bunched lumen, it resulted in the guidewire puncturing out through the inner and outer lumen.The marker bands and tip and of the device were visually and microscopically examined, and no issues were noted with the device that may have potentially contributed to the complaint incident.

• 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 IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16409185
• MDR Text Key: 309878943
• Report Number: 2124215-2023-07767
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/21/2023

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
• Device Operator: Health Professional
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0029531585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2023
• Initial Date FDA Received: 02/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2022
• 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