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 Material Rupture (1546); Difficult to Advance (2920)

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

Event Date 11/14/2023

Event Type  malfunction  

Event Description

It was reported that a balloon rupture occurred.A 10mmx3.50mm wolverine coronary cutting balloon was selected for use.During the procedure, the device was having difficulty advancing to the collar part of the guidezilla.Consecutively, it was noted that the balloon ruptured.The procedure was completed with this device.No patient complications were reported.

Event Description

It was reported that a balloon rupture occurred.A 10mmx3.50mm wolverine coronary cutting balloon was selected for use.During the procedure, the device was having difficulty advancing to the collar part of the guidezilla.Consecutively, it was noted that the balloon ruptured.The procedure was completed with this device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.A visual examination of the balloon identified no damages.Blood was present in the balloon.No issues identified with the hypotube shaft.The shaft polymer extrusion has no kinks or damages.A detailed microscopic examination of the balloon material identified a pinhole leak, 1mm proximal from the distal markerband.All blades were fully bonded on the balloon and did not exhibit any signs of damage.No issues identified during examination of the extrusion shaft.Tip showed signs of tip damage with distal section appearing deformed.A microscopic examination of the proximal and distal markerbands identified no damage.The device was successfully tracked through a recommended 0.014" guidewire and 6f guidecatheter with no issues.An attempt was then made to inflate the balloon to 12 atmospheres as per wolverine ifu using the inflation aid, however, a leak was noted coming from the pinhole tear 1mm from the proximal markerband.

• Brand Name: WOLVERINE CORONARY CUTTING BALLOON MONORAIL
• Type of Device: CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18196116
• MDR Text Key: 328921307
• Report Number: 2124215-2023-66215
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/01/2024

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: 0031504724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2023
• Initial Date FDA Received: 11/22/2023
• Supplement Dates Manufacturer Received: 12/21/2023
• Supplement Dates FDA Received: 01/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2023
• 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
• Treatment: GUIDE CATHETER - GUIDEZILLA; GUIDE CATHETER - GUIDEZILLA