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 Detachment of Device or Device Component (2907)

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

Event Date 11/12/2021

Event Type  malfunction  

Event Description

It was reported that a blade detachment occurred.The 90% stenosed target lesion was located in a moderately tortuous and severely calcified transradial artery.A 10mmx3.50mm wolverine coronary cutting balloon was selected for used.During the procedure, it was noted that the blade got separated.The device was removed without any issue and the procedure was completed with another of same device.No patient complications were reported and there was no problem with the patient's condition.

Manufacturer Narrative

Device evaluated by mfr.: the device was returned for analysis.A visual examination identified that the balloon was returned in a deflated state with solidified media present inside the balloon material.The balloon had been subjected to positive pressure.Four blades were present on the balloon surface however the following blade damage was noted: blade 1 - proximal blade segment (5mm) was missing from its pad - no issues noted with the pad; blade 2 - proximal blade segment (5mm) was missing from its pad - no issues noted with the pad; blade 3 and 4 - no issues noted.A visual and tactile examination found no issues with the hypotube of this device.No issues were noted with the tip of the device.A visual and microscopic examination found no issue with the marker bands.

Event Description

It was reported that a blade detachment occurred.The 90% stenosed target lesion was located in a moderately tortuous and severely calcified transradial artery.A 10mmx3.50mm wolverine coronary cutting balloon was selected for used.During the procedure, it was noted that the blade got separated.The device was removed without any issue and the procedure was completed with another of same device.No patient complications were reported and there was no problem with the patient's condition.

• 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: 12829635
• MDR Text Key: 280941433
• Report Number: 2134265-2021-14461
• 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: 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: 09/16/2022
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0026023281
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2021
• Initial Date FDA Received: 11/17/2021
• Supplement Dates Manufacturer Received: 12/20/2021
• Supplement Dates FDA Received: 01/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2020
• 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