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

Model Number	24674
Medical Device Problem Codes	Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 80% stenosed target lesion was located in the vein.A 7.0 x 100, 135cm mustang balloon catheter was advanced for dilation.During the procedure, the balloon was leaking and a visible pinhole was noted.The procedure was completed using an alternate method.No patient complications were reported.
Event or Problem Description
It was reported that balloon rupture occurred.The 80% stenosed target lesion was located in the vein.A 7.0 x 100, 135cm mustang balloon catheter was advanced for dilation.During the procedure, the balloon was leaking and a visible pinhole was noted.The procedure was completed using an alternate method.No patient complications were reported.It was further reported that the target lesion was located in the moderately tortuous and moderately calcified iliac artery.The balloon was ruptured upon first inflation at nominal pressure for less than a minute.The balloon was removed, and the patient was stable.
Additional Manufacturer Narrative
Device evaluated by mfr: the mustang was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A longitudinal tear was identified in the balloon material.The tear measured 15mm in length and was located in the mid region of the balloon.A visual examination observed no damage to the tip of the device.A visual and tactile examination identified a shaft kink 170mm proximal from the distal tip.
Event or Problem Description
It was reported that balloon rupture occurred.The 80% stenosed target lesion was located in the vein.A 7.0 x 100, 135cm mustang balloon catheter was advanced for dilation.During the procedure, the balloon was leaking and a visible pinhole was noted.The procedure was completed using an alternate method.No patient complications were reported.It was further reported that the target lesion was located in the moderately tortuous and moderately calcified iliac artery.The balloon was ruptured upon first inflation at nominal pressure for less than a minute.The balloon was removed, and the patient was stable.

• 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: 19923353
• Report Number: 2124215-2024-48677
• Device Sequence Number: 18161319
• Product Code: FGE
• UDI-Device Identifier: 08714729794011
• UDI-Public: 08714729794011
• 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,Followup,Followup
• Report Date (Section B): 10/27/2025

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
• Operator of Device: Health Professional
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0033428525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2024
• Supplement Date Received by Manufacturer: 08/15/2024; 10/03/2025
• Initial Report FDA Received Date: 08/06/2024
• Supplement Report FDA Received Date: 09/11/2024; 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2024
• 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
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 80 KG