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

Model Number	H74939171052010
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b - additional pro code (product code): lit.G4 - additional premarket / 510(k): k110122, k141521.The device was returned for evaluation.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The rated burst pressure for this device is 24 atmospheres as per mustang specification.The returned device was attached to an encore inflation unit.Positive pressure was applied when deionized (di) water was observed to be leaking from a balloon pinhole located approximately 4mm distal from the distal markerband.A visual examination of the markerbands identified no issues.A visual, tactile examination and leak test identified no kinks, damage or leaks to the shaft of the device.A visual and tactile examination identified no damage to the tip.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2025.It was reported that balloon leak occurred.The target lesion was located in the left lower extremity arterial stenosis.A 5.0 x 200, 135cm mustang balloon catheter was advanced for pre-dilation.During inflation at 8 atmospheres, it was noted that contrast medium overflow at the tip of the balloon.The balloon was removed from the patient's body.Upon visual inspection, fluid leakage was noted, however, there was no pinhole noted.The procedure was completed with another of the same device.No complications were reported, and the patient was stable post procedure.However, device analysis revealed a balloon pinhole located approximately 4mm distal from 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 21504109
• Report Number: 2124215-2025-12715
• Device Sequence Number: 4448703
• Product Code: FGE
• UDI-Device Identifier: 08714729793373
• UDI-Public: 08714729793373
• 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
• 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: H74939171052010
• Device Catalogue Number: H74939171052010
• Device Lot Number: 0032888022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2025
• Initial Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE: 0.035 LOACH; INTRODUCER SHEATH: COOK 6F
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 68 KG