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	12/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 70% stenosed target lesion was located in the moderately tortuous and severely calcified external iliac vein.A 12.0 x 60, 75cm mustang balloon catheter was advanced for percutaneous transluminal angioplasty.During the procedure, the middle part of the balloon burst upon second inflation at 10 atmospheres for 30 seconds.The contrast agent was leaking out after several attempts of dilation.The physician determined that the procedure could not be performed with this device.A different size of mustang balloon was used to complete the procedure.No complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was received 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 approximately 31mm in length and extended from a position 24mm proximal of the distal markerband to 6mm distal of the distal markerband.
Event or Problem Description
It was reported that balloon rupture occurred.The 70% stenosed target lesion was located in the moderately tortuous and severely calcified external iliac vein.A 12.0 x 60, 75cm mustang balloon catheter was advanced for percutaneous transluminal angioplasty.During the procedure, the middle part of the balloon burst upon second inflation at 10 atmospheres for 30 seconds.The contrast agent was leaking out after several attempts of dilation.The physician determined that the procedure could not be performed with this device.A different size of mustang balloon was used to complete the procedure.No 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: 18531816
• Report Number: 2124215-2024-02329
• Device Sequence Number: 12651752
• Product Code: FGE
• UDI-Device Identifier: 08714729794738
• UDI-Public: 08714729794738
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 02/21/2024

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: 07/06/2026
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0031963972
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/29/2023
• Supplement Date Received by Manufacturer: 01/31/2024
• Initial Report FDA Received Date: 01/17/2024
• Supplement Report FDA Received Date: 02/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2023
• 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: 32 YR
• Patient Sex: Male