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 12/27/2023

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis and investigation was completed.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A balloon longitudinal tear was identified beginning approximately 3mm distal of the distal markerband and extending approximately 26mm proximately across the balloon material.The rated burst pressure for this device as per specification 90519237 is 20 atmospheres.A visual and tactile examination found no kinks or damage to the shaft of the device.The returned device was attached to an inflation unit and positive pressure was applied using deionizes water.No liquid was observed exiting the tip of the device.Liquid was only observed exiting the tear in the balloon material.A visual and tactile examination found no damage to the tip of the device.A visual examination observed no issues with the markerbands of the device.Both markerbands were undamaged in the correct position on the device.

Event Description

Reportable based on the device analysis completed on 05mar2024.It was reported that leaking in the shaft occurred.A 7.0 x 40, 75cm mustang balloon catheter was advanced for dilatation.During the procedure, the contrast agent continued to leak out of the catheter tip while dilating.Due to this, it was confirmed that the balloon had not expanded at all.The device was removed without any problem, and the procedure was completed with another of the same device.There were no patient complications reported, and the patient was in good condition after the procedure.However, returned device analysis revealed longitudinal tear.

• 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; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18941108
• MDR Text Key: 338732120
• Report Number: 2124215-2024-16440
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729793342
• UDI-Public: 08714729793342
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0032223100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2023
• 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