MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MUSTANG; CATHETER, BILIARY, DIAGNOSTIC

Model Number 24674

Device Problem Leak/Splash (1354)

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

Event Date 02/29/2024

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 04-apr-2024.It was reported that balloon leakage occurred.The 85% stenosed target lesion was located in the moderately tortuous and severely calcified arteria cruralis.A 5.0 x 40, 135cm mustang balloon catheter was advanced for in a placed stent for dilation.During the procedure, leakage was found during expansion preventing the lesion from being fully dilated in the patient.The procedure was completed with another of the same device.No patient complications were reported.However, device analysis revealed a balloon pinhole located at the distal markerband.

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of a mustang balloon catheter.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A leak test identified a balloon pinhole located at the distal markerband.The rated burst pressure for this device is 24 atmospheres.

• Brand Name: MUSTANG
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• 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: 19201227
• MDR Text Key: 341267560
• Report Number: 2124215-2024-23863
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729793465
• UDI-Public: 08714729793465
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K141521
• 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: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/02/2024
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0026902342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2021
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 75 KG