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 10/25/2021

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.

Event Description

It was reported that the shaft has pinhole.The 99% stenosed target lesion was located in the mildly tortuous and moderately calcified left circumflex coronary artery.A 10mmx2.50mm wolverine coronary cutting balloon was selected for use.Resistance was encountered while advancing into the guide catheter.A kink occurred while within the guide catheter.It was noted that a leak/pin hole occurred from the shaft part.The procedure was completed with a different device.No patient complications reported.

Event Description

It was reported that the shaft has pinhole.The 99% stenosed target lesion was located in the mildly tortuous and moderately calcified left circumflex coronary artery.A 10mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that a leak occurred from the shaft part.There was a possibility of pinhole damage due to kink.The procedure was completed with a different device.No patient complications reported.

Manufacturer Narrative

A2 - age at time of event: 18 years or older device evaluated by manufacturer: wolverine cb mr, ous 10mmx2.50mm was returned for analysis.A visual examination identified that the balloon was in a deflated state and had been subjected to positive pressure.There were no issues noted with the balloon material.All blades were securely bonded and no damage to the blades were noted.All blades were intact within their pads and fully bonded to the balloon material.The markerbands 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.A visual and tactile examination of the hypotube identified no issues.Damage was noted throughout the length of the shaft polymer extrusion.The outer lumen was found to be bunched in several areas.The inner wire was found to have punctured the outer lumen at approx.6 cm distal to the guidewire port.

• 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: 12786905
• MDR Text Key: 280581105
• Report Number: 2134265-2021-14149
• 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,Followup
• Report Date: 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/07/2023
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0027625058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2021
• 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
• Patient Sex: Male