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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in the venous fistula.A 6.0 x 60, 75cm mustang balloon catheter was advanced for dilatation.During the procedure, the balloon was failed to dilate and the balloon was ruptured.The procedure was completed with another of the same device.There were no patient complications reported.
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in the venous fistula.A 6.0 x 60, 75cm mustang balloon catheter was advanced for dilatation.During the procedure, the balloon was failed to dilate and the balloon was ruptured.The procedure was completed with another of the same device.There were no patient complications reported.It was further reported that the 85% stenosed target lesion was located in the mildly tortuous and moderately calcified lesion.The balloon was ruptured after the 2 - 3 times inflation at 24 atmospheres.
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in the venous fistula.A 6.0 x 60, 75cm mustang balloon catheter was advanced for dilatation.During the procedure, the balloon was failed to dilate and the balloon was ruptured.The procedure was completed with another of the same device.There were no patient complications reported.It was further reported that the 85% stenosed target lesion was located in the mildly tortuous and moderately calcified lesion.The balloon was ruptured after the 2 - 3 times inflation at 24 atmospheres.
Additional Manufacturer Narrative
Device evaluated by mfr: the device 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 5mm proximal from the distal markerband.Both markerbands were undamaged and present on the shaft of the device.This concludes the product analysis.

• 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: 20198540
• Report Number: 2124215-2024-56819
• Device Sequence Number: 7584097
• Product Code: FGE
• UDI-Device Identifier: 08714729793762
• UDI-Public: 08714729793762
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/26/2024

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 Expiration Date: 08/23/2026
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0032285036
• 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: 08/22/2024
• Supplement Date Received by Manufacturer: 09/11/2024; 10/31/2024
• Initial Report FDA Received Date: 09/12/2024
• Supplement Report FDA Received Date: 09/30/2024; 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2023
• 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 Sex: Unknown