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

Model Number	H74939206080810
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b: pro code: (product code): fge, lit.G4: premarket / 510(k): k112697, k112701, k141521.
Event or Problem Description
It was reported that a balloon rupture occurred.A 8.0 x 80, 135 cm charger balloon catheter was advanced for dilatation.During inflation, the balloon ruptured.The device was removed, and the procedure was completed with no patient complications resulting from 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: 23569392
• Report Number: 2124215-2025-83442
• Device Sequence Number: 10120213
• Product Code: FGE
• UDI-Device Identifier: 08714729804697
• UDI-Public: (01)08714729804697(17)260419(10)31452840
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K112697
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 11/17/2025

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: 04/19/2026
• Device Model Number: H74939206080810
• Device Catalogue Number: H74939206080810
• Device Lot Number: 0031452840
• 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: 10/29/2025
• Initial Report FDA Received Date: 11/17/2025
• Date Device Manufactured: 04/20/2023
• 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
• Patient Sex: Unknown