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	07/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reported facility name: (b)(6) hospital.
Event or Problem Description
It was reported that balloon rupture occurred.The 86% stenosed target lesion was located in the mildly tortuous and moderately calcified abdominal aorta.A 8.0 x 60, 135cm mustang balloon catheter was advanced for dilatation.During the procedure, the balloon ruptured after not exceeding burst pressure in the first inflation.The device was removed without any problem, and the procedure was completed with another of the same device.There were no patient complications reported, and the patient was in good condition after the procedure.
Event or Problem Description
It was reported that balloon rupture occurred.The 86% stenosed target lesion was located in the mildly tortuous and moderately calcified abdominal aorta.A 8.0 x 60, 135cm mustang balloon catheter was advanced for dilatation.During the procedure, the balloon ruptured after not exceeding burst pressure in the first inflation.The device was removed without any problem, and the procedure was completed with another of the same device.There were no patient complications reported, and the patient was in good condition after the procedure.
Additional Manufacturer Narrative
E1: initial reported facility name: (b)(6).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 leak test identified a leak from the shaft of the device.Isual and tactile examination found damage to the shaft of the device, potentially a cut located approximately 300mm distal of the strain relief.This type of damage could potentially have been due to the device having an interaction with a sharp object or another device.A leak test identified a leak in the shaft located at the site of the damage approximately 300mm distal of the strain relief.This type of damage could potentially have been due to the device having an interaction with a sharp object or another device.

• 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: 19833655
• Report Number: 2124215-2024-45305
• Device Sequence Number: 7513760
• Product Code: FGE
• UDI-Device Identifier: 08714729794714
• UDI-Public: 08714729794714
• 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
• Report Date (Section B): 09/06/2024

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: 01/31/2026
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0030954958
• 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: 07/04/2024
• Supplement Date Received by Manufacturer: 08/19/2024
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2023
• 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 Age: 60 YR
• Patient Sex: Unknown
• Patient Weight: 80 KG