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 Leak/Splash (1354); Material Deformation (2976)

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

Event Date 02/28/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The device was returned for analysis.A visual examination revealed that the balloon was in a deflated state and had been subjected to positive pressure.There were no issues noted with the balloon, however blood was visible inside the balloon material.All blades were securely bonded and no damage to the blades was noted.All blades were intact within their pads and fully bonded to the balloon material.The markerbands and tip 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.A visual and tactile examination of the hypotube identified no issues.Damage was noted on the shaft polymer extrusion.The outer lumen was found to have a pinhole present at 13cm distal to the guidewire lumen.No other issues were noted with this device.

Event Description

Reportable based on device analysis completed on 11apr2022.It was reported that a shaft kink occurred.A 10mmx3.00mm wolverine coronary cutting balloon was selected for use.During the procedure, the device was only able to partially expand on the first inflation and pressure would not increase.It was noted that the contrast reached the balloon and there was no evidence of a leak.The device was removed and it was noted that the shaft was kinked and leaking at about 15 to 20 cm from the tip.The procedure was completed with another of same device.No patient complications were reported.However, device analysis revealed that the outer lumen had a pinhole at 13cm distal to the guidewire lumen.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14115917
• MDR Text Key: 289315189
• Report Number: 2134265-2022-04293
• 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: 04/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/25/2023
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0028451339
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2021
• 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