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

Model Number	24674
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	08/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the balloon broke.An attempt was made to recanalize an arteriovenous fistula (avf), precisely of the cephalic end.A 4mm mustang balloon catheter was used followed by a 6x80mm mustang balloon catheter, which broke off.There was great difficulty removing the balloon because it was torn and retracted.It was impossible to remove through the non-boston scientific introducer.A hematoma appeared at the entry point of the introducer with a piece of balloon stuck in the vein.The introducer was removed, and a 9f probe was placed in contact with the severed balloon.After multiple maneuvers, the entire balloon was removed.No further patient complications were reported.

• Brand Name: MUSTANG
• Common Device Name: 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: 17715625
• Report Number: 2124215-2023-49055
• Device Sequence Number: 11325501
• Product Code: FGE
• UDI-Device Identifier: 08714729793854
• UDI-Public: 08714729793854
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K141521
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/22/2025
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0030589047
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/17/2023
• Initial Report FDA Received Date: 09/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown