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 Inflation Problem (1310); Leak/Splash (1354)

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

Event Date 12/29/2023

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.A visual examination identified blood inside the balloon.Multiple kinks were identified along the hypotube shaft.Visual examination could not identify any kinks or damages.A detailed microscopic examination of the balloon material identified a pinhole 1mm distal from proximal markerband when inflated to rated burst pressure.All blades were fully bonded on the balloon and did not exhibit any signs of damage.No kinks or damages noted on the shaft polymer extrusion.Tip showed no signs of tip damage.A microscopic examination of the proximal and distal markerbands identified no damage.The device was attached to an encore inflation device.An attempt was then made to inflate the balloon to 12 atmospheres however, pressure was unable to be maintained as inflation liquid was observed leaking from the pinhole identified 1mm distal from proximal markerband.No other device issues were identified during returned product analysis.

Event Description

Reportable based on device analysis completed on 28mar2024.It was reported that air leakage was suspected.The 90% stenosed target lesion was located in a diffused plaque near the middle section of the right coronary artery.A 10mmx2.25mm wolverine coronary cutting balloon was selected for use.During the procedure, when the pressure pump was pressed, the pressure did not go up.After the balloon was removed from the outside, the pressure did not go up again, and air leakage was suspected but there was no pinhole noted.The device was slowly removed along the guidewire and procedure was completed with another of the same device.No complications reported and patient was stable.However, device analysis revealed a balloon pinhole.

• 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: 19019443
• MDR Text Key: 339119399
• Report Number: 2124215-2024-19316
• 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: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/02/2024

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: 0031450627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2024
• Initial Date FDA Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2023
• 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: 63 YR
• Patient Sex: Female
• Patient Weight: 52 KG