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

Model Number	H74939171080410
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b - additional pro code (product code): lit.G4 - additional premarket / 510(k): k141597.
Event or Problem Description
It was reported that removal difficulty occurred.The target lesion was located at a vessel of below the knee.An 8.0 x 40, 135cm mustang balloon catheter was selected for use.During the procedure, the balloon could not be retracted.The procedure was completed another of the same device.No complications were reported, and the patient was stable post procedure.
Event or Problem Description
It was reported that removal difficulty occurred.The target lesion was located at a vessel of below the knee.An 8.0 x 40, 135cm mustang balloon catheter was selected for use.During the procedure, the balloon could not be retracted.The procedure was completed another of the same device.No complications were reported, and the patient was stable post procedure.It was further reported that the device was simply pulled out and there was no device fragments left inside the patient's body.
Additional Manufacturer Narrative
D2b - additional pro code (product code): lit.G4 - additional premarket / 510(k): k141597.Device evaluated by mfr: the device was returned for evaluation.A visual examination of the returned device found that the balloon had been inflated and was not refolded.It is not known when the balloon was subjected to positive pressure.A visual examination of the markerbands identified no issues.A visual and tactile examination identified no kinks or damage to the shaft and to the tip.No other issues were identified during the product analysis.

• 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: 21307497
• Report Number: 2124215-2025-05702
• Device Sequence Number: 15496082
• Product Code: FGE
• UDI-Device Identifier: 08714729793663
• UDI-Public: 08714729793663
• 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): 03/03/2025

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: H74939171080410
• Device Catalogue Number: H74939171080410
• Device Lot Number: 0033131372
• 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: 01/08/2025
• Supplement Date Received by Manufacturer: 02/05/2025
• Initial Report FDA Received Date: 02/04/2025
• Supplement Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2024
• 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: 76 YR
• Patient Sex: Male
• Patient Weight: 51 KG