MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON MONORAIL; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING

Model Number 3852

Device Problem Inflation Problem (1310)

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

Event Date 07/01/2023

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on (b)(6) 2023.It was reported that the device was defective.A 15mmx4.00mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the device was defective and could not be used.The procedure was completed with another wolverine coronary cutting balloon.There were no patient complications reported post procedure.However, device analysis revealed a hypotube break located at 21.2cm distal from the strain relief.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The device was received in two sections as a result of a break in the hypotube shaft.The break was located at 21.2cm distal from the strain relief.A kink was located in the proximal section of the break at 19cm distal from the strain relief.A visual and tactile examination identified no damage to the distal extrusion.A microscopic examination of the distal extrusion identified no damages.A detailed microscopic examination of the balloon material identified no damages.There were no tears or holes observed in the balloon material.All blades were fully bonded on the balloon and did not exhibit any signs of damage.A microscopic examination of the tip section found no damage.

• 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: 17826405
• MDR Text Key: 324380871
• Report Number: 2124215-2023-48898
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: CI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3852
• Device Catalogue Number: 3852
• Device Lot Number: 0030447537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2022
• 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 Sex: Male