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

Model Number	24674
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a part of the balloon broke off.The target lesion was located in the arteriovenous fistula.A 035 x 260 non-boston scientific stiff guidewire was placed and a 5.0 x 100, 135cm mustang balloon catheter was advanced for dilation with encore inflation device.During the procedure, the balloon was inflated third to fourth time at 20 atmospheres in the cephalic vein.However, the balloon burst, and a part of the balloon was detached in the radial artery.A snare wire was used but it could not remove the detached component.After that, no other device was used in the procedure.The patient was given anticoagulant medicine and heparin.

• 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: 18713915
• Report Number: 2124215-2024-07017
• Device Sequence Number: 5805304
• Product Code: FGE
• UDI-Device Identifier: 08714729793533
• UDI-Public: 08714729793533
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 02/15/2024

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: 01/11/2025
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0028666136
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2024
• Initial Report FDA Received Date: 02/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE: 035 TERUMO; INFLATION DEVICE: ENCORE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown