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

Model Number	H74939171060410
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b: product code - lit e1- initial reporter facility name: (b)(6) hospital g4: pma/510(k) # field on 3500a form - k141597.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 partial balloon circumferential tear was identified located approximately 8mm proximal of the distal balloon markerband.Visual examination observed no damage to the tip of the device.Visual and tactile examination found no kinks or damage to the shaft of the device.Both markerbands were undamaged and present on the shaft of the device.
Event or Problem Description
Reportable based on device analysis completed on 21nov2024 it was reported that balloon leak occurred.A 6.0 x 40, 135cm mustang balloon catheter was advanced for dilation.During the procedure, the balloon was delivered to the lesion site along the v18 guide wire, the contrast medium was injected, and the lesion site was developed.When the balloon was pressed to 10 atm, it was found that the balloon leaked and could not be opened.A visible pinhole noted on the balloon material which contributed to the leak failure was unknown.The device was removed without any problem, and the procedure was completed with another of same device.There was no patient complications reported, and the patient condition following procedure was stable.However, device analysis revealed that a partial balloon circumferential tear was identified.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20924203
• Report Number: 2124215-2024-78326
• Device Sequence Number: 20100782
• Product Code: FGE
• UDI-Device Identifier: 08714729793472
• UDI-Public: 08714729793472
• 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
• Report Date (Section B): 12/13/2024

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 Model Number: H74939171060410
• Device Catalogue Number: H74939171060410
• Device Lot Number: 0032913651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2024
• Initial Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2023
• 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: Male