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

Model Number 24674

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

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

Event Date 03/05/2021

Event Type  malfunction  

Event Description

It was reported that the balloon failed to inflate.A mustang balloon 10.0 x 40, 75cm was selected for a biliary angioplasty procedure.During the procedure, however, the balloon did not inflate.It was removed outside of the patient, and the inflation was seen leaking.The procedure was completed using a different device.There were no complications reported and the patient condition was stable following the procedure.

Manufacturer Narrative

Device evaluation by manufacturer: mustang 10.0 x 40, 75cm, batch# 26298473, 14atm was received for analysis.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.The returned device was attached to an encore inflation unit.Positive pressure was applied using glycerol/water when liquid was observed to be leaking from a balloon pinhole located approximately 12mm proximal of the proximal markerband.The balloon could not maintain pressure due to the pinhole.The rated burst pressure for this device is 14 atmospheres as per mustang specification.A visual examination observed no issues or damage to the tip of the device.A visual and tactile examination found no kinks or damage the shaft of the device.A visual examination observed no issues with the markerbands of the device.Both markerbands were undamaged and present on the shaft of the device.This concludes the product analysis.

• Brand Name: MUSTANG
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16482279
• MDR Text Key: 310675297
• Report Number: 2124215-2023-09188
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729793359
• UDI-Public: 08714729793359
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K141521
• 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: 03/03/2023

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 Expiration Date: 11/04/2023
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0026298473
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2023
• Initial Date FDA Received: 03/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1