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

Model Number	H74939206040470
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b: pro code (product code): fge, lit.G4: premarket / 510(k) #: k112697, k112701.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the left upper limb.A 4.0 x40, 75cm charger balloon catheter was advanced for dilation.During the procedure, the balloon was pressurized to 20 atmospheres and the pressure was removed.The balloon continued to enter and was inflated.It was observed that the pressure pump value did not rise, and the contrast medium flowed back with the blood flow.The balloon was judged to be ruptured, the balloon was withdrawn, and the procedure was completed with a different device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
D2b: pro code (product code): fge, lit.G4: premarket / 510(k) #: k112697, k112701.E1 - initial reporter phone:(b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the left upper limb.A 4.0 x40, 75cm charger balloon catheter was advanced for dilation.During the procedure, the balloon was pressurized to 20 atmospheres and the pressure was removed.The balloon continued to enter and was inflated.It was observed that the pressure pump value did not rise, and the contrast medium flowed back with the blood flow.The balloon was judged to be ruptured, the balloon was withdrawn, and the procedure was completed with a different device.There were no patient complications as a result of this event.It was further reported that the 67 % stenosed target lesion was located in the radial artery to basilic vein arteriovenous fistula anastomosis site and the device was removed without any problem using the normal method.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the left upper limb.A 4.0 x40, 75cm charger balloon catheter was advanced for dilation.During the procedure, the balloon was pressurized to 20 atmospheres, and the pressure was removed.The balloon continued to enter and was inflated.It was observed that the pressure pump value did not rise, and the contrast medium flowed back with the blood flow.The balloon was judged to be ruptured, the balloon was withdrawn, and the procedure was completed with a different device.There were no patient complications as a result of this event.It was further reported that the 67% stenosed target lesion was located in the radial artery to basilic vein arteriovenous fistula anastomosis site and the device was removed without any problem using the normal method.
Additional Manufacturer Narrative
D2b: pro code (product code): fge, lit.G4: premarket / 510(k) #: k112697, k112701.(b)(6).Device evaluated by mfr: 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.A longitudinal tear was identified in the balloon material.The tear measured 22mm in length and extended from a position 2mm distal of the proximal markerband to 24mm distal of the proximal markerband.A visual examination observed no damage to the tip of the device.A visual and tactile examination of the shaft of the device found no issues.A visual examination found no issues or damage to the markerbands of the device.No other issues were identified during the product analysis.

• 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: 22733844
• Report Number: 2124215-2025-54343
• Device Sequence Number: 8884782
• Product Code: FGE
• UDI-Device Identifier: 08714729804116
• UDI-Public: (01)08714729804116(17)270307(10)33576885
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/04/2025

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: H74939206040470
• Device Catalogue Number: H74939206040470
• Device Lot Number: 0033576885
• 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: 07/15/2025
• Supplement Date Received by Manufacturer: 08/19/2025; 10/09/2025
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 09/12/2025; 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2024
• 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: 60 YR
• Patient Sex: Female
• Patient Weight: 72 KG