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 Inflation Problem (1310); Material Rupture (1546)

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

Event Date 08/19/2022

Event Type  malfunction  

Event Description

It was reported that a balloon rupture occurred.The 80% stenosed target lesion was located in the non-tortuous and moderately calcified coronary artery.A 10mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon was ruptured at 4 atm for a few seconds and could not inflate.The device was removed as normal and the procedure was completed with another of same device.No complications were reported and patient was stable post procedure.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for evaluation.A visual examination identified that the balloon was returned with its wings intact.The returned device was attached to an encore inflation unit and positive pressure was applied in an attempt to inflate the balloon.Liquid was observed to be leaking from a balloon pinhole located in the proximal balloon cone.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.The rated burst pressure for this device is 12 atmospheres as per wolverine ifu.All blades were intact within their pads and fully bonded to the balloon material.A visual and tactile examination of the hypotube identified no issues.A visual and tactile examination of the shaft polymer extrusion identified no issues.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.

Event Description

It was reported that a balloon rupture occurred.The 80% stenosed target lesion was located in the non-tortuous and moderately calcified coronary artery.A 10mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon was ruptured at 4 atm for few seconds and could not inflate.The device was removed as normal and the procedure was completed with another of same device.No complications were reported and patient was stable post procedure.

• 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: 15451186
• MDR Text Key: 303942358
• Report Number: 2124215-2022-36627
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/19/2024
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0029255664
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2022
• 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
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 65 KG