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

Model Number	H74939171040610
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.A visual examination identified that the balloon was not folded, which indicates that the device was subjected to positive pressure.A leak test was carried out and the balloon was inflated to its rated burst pressure for 30 seconds using deionized water and digital timer without issue.A vacuum was then applied.The inflation device was verified at 24 atmospheres, before and after use with calibrated pressure gauge.This inflation to rate of burst pressure was repeated three times with no leaks or drop in pressure noted.No issues were identified with balloon inflation or the balloon material.As per mustang specification, the rated burst pressure for this device is 24 atmospheres.No issues were noted with the tip of the device and markerbands.A visual and tactile examination found the shaft of the device to be kinked at more than one location.
Event or Problem Description
It was reported that balloon pinhole occurred.The target lesion was located in the femoral artery.A 4.0 x 60, 135cm mustang balloon catheter was advanced and inflated the shunt.However, the balloon could not be fully opened when dilating the stenosis.The device was withdrawn, and a visible pinhole was noted on the balloon material.The procedure was completed with another of the same device.No complications were reported, and the patient condition following procedure was stable.
Event or Problem Description
It was reported that balloon pinhole occurred.The target lesion was located in the femoral artery.A 4.0 x 60, 135cm mustang balloon catheter was advanced and inflated the shunt.However, the balloon could not be fully opened when dilating the stenosis.The device was withdrawn, and a visible pinhole was noted on the balloon material.The procedure was completed with another of the same device.No complications were reported, and the patient condition following procedure was stable.
Additional Manufacturer Narrative
D2b pro code (product code): fge, lit.

• 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 ; 6512422111
• MDR Report Key: 21015257
• Report Number: 2124215-2024-81865
• Device Sequence Number: 6678068
• Product Code: FGE
• UDI-Device Identifier: 08714729794257
• UDI-Public: 08714729794257
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 02/05/2025

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 Expiration Date: 05/23/2025
• Device Model Number: H74939171040610
• Device Catalogue Number: H74939171040610
• Device Lot Number: 0029457795
• 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: 12/05/2024
• Supplement Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 12/25/2024
• Supplement Report FDA Received Date: 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2022
• 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: 63 YR
• Patient Sex: Female
• Patient Weight: 60 KG