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 Difficult to Advance (2920); Material Deformation (2976)

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

Event Date 10/05/2023

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: the device was returned for evaluation.The following attributes were examined.A visual examination of the balloon identified no damages.A hypotube break was identified, 19cm distal to the distal end of the strain relief and multiple hypotube kinks along the shaft of the device.No kinks or damages noted on the shaft polymer extrusion.For microscope analysis, a detailed microscopic examination of the balloon material identified no tears or pinholes in the balloon.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 no signs of tip damage.A microscopic examination of the proximal and distal marker bands identified no damage.For device to device interaction test, the device could be loaded and tracked on a 0.014 inches test guidewire and 6fr guide catheter without issues.

Event Description

Reportable based on device investigation completed on (b)(6) 2023.It was reported that device kinked occurred.A 10mmx3.50mm wolverine coronary cutting balloon was selected for use.During the procedure, significant resistance was encountered upon inserting this device into a boston scientific guide catheter and a device kinked was noted.The device was removed without any problem and the procedure was completed with another wolverine device.No complications reported.However, device analysis revealed that a hypotube break was identified, 19cm distal to the distal end of the strain relief.

• 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: 18064060
• MDR Text Key: 327244838
• Report Number: 2124215-2023-59946
• 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: 11/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2023
• 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: 0029764297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2022
• 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
• Treatment: GUIDE CATHETER-7F GUIDEZILLA