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 Leak/Splash (1354); Material Integrity Problem (2978)

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

Event Date 05/31/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned for analysis.Visual/tactile inspection revealed no issue with the hypotube shaft and distal extrusion and that there was a build up of blood inside the balloon.Microscopic inspection was performed.No tears or pinholes were noted in the balloon and although a pinhole leak was confirmed during balloon inflation attempts using an encore inflation device, an examination of the balloon material at the site of the pinhole leak identified no issues with the balloon material which could have contributed to the complaint event.The pinhole was located at the proximal edge of the proximal transition zone in the balloon.All blades were fully bonded on the balloon and did not exhibit any signs of damage.No issues were identified during examination of the extrusion shaft.A microscopic examination of the proximal and distal markerbands identified no damage.

Event Description

Reportable based on the device analysis completed on 24aug2023.It was reported that device damage and leaking occurred.The 82% stenosed target lesion was located in the moderately tortuous and calcified left anterior descending artery (lad).A 10mmx2.25mm wolverine coronary cutting balloon was advanced to the target lesion using a guide extension catheter.When the balloon reached the target location and pressure was applied it was noted that the catheter was deformed proximally.When the balloon was removed from the patient, it was noted that contrast was leaking, and the balloon could no longer be used.The procedure was completed with another of the same device.There were no patient complications reported.However, device analysis revealed that there was a 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 CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17638032
• MDR Text Key: 322278714
• Report Number: 2124215-2023-46377
• 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: 08/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2023
• 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: 0030703084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2022
• 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 Age: 65 YR
• Patient Sex: Male
• Patient Weight: 72 KG