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 12/15/2022

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 26-jan-2023.It was reported that balloon leak occurred.The patient underwent shunt vascular balloon dilatation.The 50% stenosed target lesion was located in a shunt in a moderately tortuous and non-calcified vessel in the left hand.After the guidewire crossed the lesion, a 6.0 x 100, 75cm mustang balloon catheter was advanced for dilation.However, during inflation, the balloon did not inflate until it reached the nominal pressure and leakage of contrast medium was observed.The procedure was completed with a different device.No patient complications were reported.However, returned device analysis revealed that balloon had a tear.

Manufacturer Narrative

(a2) age at time of event: 18 years or older.Device evaluated by mfr.: mustang 6.0 x 100, 75cm was received for analysis.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.A balloon longitudinal tear was identified beginning approximately 5mm proximal of the proximal and extending approximately 45mm distally across the balloon material.The rated burst pressure for this device is 24 atmospheres.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; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16274147
• MDR Text Key: 308577507
• Report Number: 2124215-2023-03871
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729793625
• UDI-Public: 08714729793625
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 01/31/2023

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 Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0029547487
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2023
• Initial Date FDA Received: 01/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2022
• 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 Sex: Male