MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MUSTANG; STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS

Model Number	H74939171031510
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b - pro code (product code): fge, lit g4 - premarket / 510(k) #: k103751, k110122, k141521.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 leak test identified a balloon pinhole located approximately 22mm proximal of the distal markerband.The rated burst pressure for this device as per specification is 24 atmospheres.A visual and tactile examination found no kinks or damage to the shaft and 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
Reportable based on device analysis completed on 15jan2025.The 80% stenosed target lesion was located in the mildly tortuous and severely calcified left femoral artery.A 3.0 x 150, 135cm mustang balloon was advanced for dilation.During the procedure, the patient was in the supine position, and the physician punctured the lesion with 8f, and successfully placed the sheath and guiding catheter.When the balloon reached the lesion site, the pressure pump was pressurized at 4 atmospheres.However, it was noted that the balloon could not be inflated, showing that there was extravasation of contrast medium.When the balloon was withdrawn, it was found that the middle end of the balloon was damaged, and then it was withdrawn from the body.The procedure was completed with another of the same device.The patient's condition following the procedure was stable.However, device analysis revealed a balloon pinhole located approximately 22mm proximal of the distal markerband.

• Brand Name: MUSTANG
• Common Device Name: STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS
• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 6128757234
• MDR Report Key: 21307479
• Report Number: 2124215-2025-05859
• Device Sequence Number: 21044978
• Product Code: FGE
• UDI-Device Identifier: 08714729794516
• UDI-Public: 08714729794516
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 02/04/2025

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: H74939171031510
• Device Catalogue Number: H74939171031510
• Device Lot Number: 0034091583
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2025
• Initial Report FDA Received Date: 02/04/2025
• Date Device Manufactured: 05/23/2024
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 70 KG