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

Model Number	H74939206100470
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G4: premarket / 510(k) #: k112697, k112701, k141521.
Event or Problem Description
It was reported that balloon burst occurred.The target lesion was located in the peripheral artery.A 10.0 x40, 75cm charger was used for dilation.During the procedure, a successful angiography with a 6 french sheath, was performed and the lesion was crossed with a wire.Ivus was also successfully performed.However, there was a leak at the balloon package opening, preventing balloon dilation.The balloon ruptured on the first inflation.The procedure was completed with a different device.There were no patient complications as a result of this event.

• Brand Name: CHARGER
• 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: 21707557
• Report Number: 2124215-2025-18443
• Device Sequence Number: 4656754
• Product Code: FGE
• UDI-Device Identifier: 08714729803799
• UDI-Public: 08714729803799
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/27/2025

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: H74939206100470
• Device Catalogue Number: H74939206100470
• Device Lot Number: 0033063854
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 03/27/2025
• Date Device Manufactured: 12/18/2023
• 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 Age: 72 YR
• Patient Sex: Male