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 Leak/Splash (1354)

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

Event Date 01/16/2024

Event Type  malfunction  

Event Description

It was reported that the balloon was torn.The 50% stenosed target lesion was located in the middle to distal left anterior descending artery (lad).A 10mmx2.00mm wolverine coronary cutting balloon was selected for use.During preparation, when the air in the balloon was removed outside the patient, the balloon was torn or had a hole, so the air had come out.The procedure was completed with another of the same device.There were no patient complications reported.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.Visual, tactile, microscopic, and leakage analysis were performed on the device.A visual and tactile examination identified no damages hypotube shaft profile and shaft polymer extrusion.A visual examination identified some traces of blood inside the balloon.A detailed microscopic examination of the balloon material identified no tears or damages.All blades were fully bonded onto the balloon.A microscopic examination of the tip section and proximal markerband found no damages.The device was attached to an encore inflation unit and liquid leaked out through a pinhole leak.The pinhole leak was noted over the proximal markerband.

Event Description

It was reported that the balloon was torn.The 50% stenosed target lesion was located in the middle to distal left anterior descending artery (lad).A 10mmx2.00mm wolverine coronary cutting balloon was selected for use.During preparation, when the air in the balloon was removed outside the patient, the balloon was torn or had a hole, so the air had come out.The procedure was completed with another of the same device.There were no patient complications reported.

• 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: 18681414
• MDR Text Key: 335093936
• Report Number: 2124215-2024-04713
• 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: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• 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: 0031965062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2023
• 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