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

Model Number	24672
Medical Device Problem Codes	Leak/Splash (1354); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a balloon burst occurred.The stenosed target lesion was located in the superficial femoral artery.A 5.0 x 150, 135cm mustang balloon was used to relieve and treat the lesion stenosis in the patient.During the process of dilatation, the balloon burst and the contrast agent leaked out.The device was removed from the patient's body, and further dilatation was attempted, but it did not expand, and the contrast agent leaked out of the balloon.The procedure was completed normally by replacing it with another of the same device.No complications were reported, and the patient was in good condition post-procedure.
Additional Manufacturer Narrative
Device evaluated by mfr: the complaint device was received for product analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A balloon longitudinal tear was identified beginning approximately 50mm proximal of the distal markerband and extending approximately 20mm proximally across the balloon material.A visual and tactile examination found no kinks or damage to the shaft of the device.A visual and tactile examination found no damage to the tip of the device.A visual examination observed no issues with the markerbands of the device.Both markerbands were undamaged in the correct position on the device.This concludes the product analysis.
Event or Problem Description
It was reported that a balloon burst occurred.The stenosed target lesion was located in the superficial femoral artery.A 5.0 x 150, 135cm mustang balloon was used to relieve and treat the lesion stenosis in the patient.During the process of dilatation, the balloon burst and the contrast agent leaked out.The device was removed from the patient's body, and further dilatation was attempted, but it did not expand, and the contrast agent leaked out of the balloon.The procedure was completed normally by replacing it with another of the same device.No complications were reported, and the patient was in good condition post-procedure.

• 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: 18851154
• Report Number: 2124215-2024-13785
• Device Sequence Number: 20628326
• Product Code: LIT
• UDI-Device Identifier: 08714729793434
• UDI-Public: 08714729793434
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K103751
• 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): 04/29/2024

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: 09/26/2026
• Device Model Number: 24672
• Device Catalogue Number: 24672
• Device Lot Number: 0032512230
• 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: 02/28/2024
• Supplement Date Received by Manufacturer: 04/24/2024
• Initial Report FDA Received Date: 03/06/2024
• Supplement Report FDA Received Date: 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2023
• 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: Male