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 Material Integrity Problem (2978)

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

Event Date 12/10/2023

Event Type  malfunction  

Manufacturer Narrative

E1: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.Visual, tactile, microscopic, and functional analysis were performed on the device.A visual examination of the balloon identified no damages.No issues identified with the hypotube shaft.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.The inner wire lumen was kinked just distal from the distal markerband and a pinhole was noted on the wire lumen just proximal of the distal markerband.No issues were with the tip of the device.A microscopic examination of the proximal and distal markerbands identified no damage.The device was attached to an encore inflation unit.The encore inflation device was verified before and after the procedure using a druck gauge.When attempting to inflate the balloon, it would not hold pressure.The inflation liquid was coming in through the pinhole on the inner wire lumen and exited out from the tip of the device.

Event Description

Reportable based on the device analysis completed on (b)(6) 2024.It was reported that a leak occurred.The target lesion was located in the left anterior descending artery (lad).A 10mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the device was leaking gas, and it could not be dilated by the pressure pump.The procedure was completed with a different device.There were no complications reported and the patient was stable post procedure.However, the device analysis revealed that there was a pinhole noted on the wire lumen.

• 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 CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18893748
• MDR Text Key: 337630484
• Report Number: 2124215-2024-11543
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/13/2024

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: 0031654865
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2024
• Initial Date FDA Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2023
• 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
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 60 KG