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

Model Number	H74939206070470
Medical Device Problem Codes	Leak/Splash (1354); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b: pro code: (product code): fge, lit.G4: premarket/510(k): k112697, k112701, k141521.E1: initial reporter facility name: (b)(6) hospital.E1: initial reporter phone: (b)(6).
Event or Problem Description
It was reported that a balloon rupture occurred.The 90% stenosed target lesion was located in the non-tortuous, moderately calcified brachial artery.A 7.0 x 40 mm, 75 cm charger balloon catheter was advanced for dilatation.During the procedure, the balloon ruptured and leaked fluid.The rupture point was noted at approximately 2 cm.The device was removed, and the procedure was completed with another of same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
A2 - age at time of event: 18 years or older.B5 - describe event or problem: updated to include new information obtained.D2b: pro code: (product code): fge, lit g4: premarket / 510(k): k112697, k112701, k141521 e1: initial reporter facility name: (b)(6).E1: initial reporter phone: (b)(6).
Event or Problem Description
It was reported that a balloon rupture occurred.The 90% stenosed target lesion was located in the non-tortuous, moderately calcified brachial artery.A 7.0 x 40 mm, 75 cm charger balloon catheter was advanced for dilatation.During the procedure, the balloon ruptured and leaked fluid.The rupture point was noted at approximately 2 cm.The device was removed, and the procedure was completed with another of same device.There were no patient complications as a result of this event.It was further reported that during the initial inflation at 10 atmospheres for 5 seconds, the balloon ruptured.
Additional Manufacturer Narrative
A2 - age at time of event: 18 years or older.B5 - describe event or problem: updated to include new information obtained.D2b: pro code: (product code): fge, lit.G4: premarket / 510(k): k112697, k112701, k141521.E1: initial reporter facility name: (b)(6).E1: initial reporter phone: (b)(6).A charger device was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A balloon pinhole was identified, confirming the event.No issues were noted with the tip or markerbands of the device and no kinks or damage was noted along the shaft of the device.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that a balloon rupture occurred.The 90% stenosed target lesion was located in the non-tortuous, moderately calcified brachial artery.A 7.0 x 40 mm, 75 cm charger balloon catheter was advanced for dilatation.During the procedure, the balloon ruptured and leaked fluid.The rupture point was noted at approximately 2 cm.The device was removed, and the procedure was completed with another of same device.There were no patient complications as a result of this event.It was further reported that during the initial inflation at 10 atmospheres for 5 seconds, the balloon ruptured.

• 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: 23566794
• Report Number: 2124215-2025-83366
• Device Sequence Number: 10173053
• Product Code: FGE
• UDI-Device Identifier: 08714729804536
• UDI-Public: (01)08714729804536(17)270502(10)33946878
• 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): 01/20/2026

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: H74939206070470
• Device Catalogue Number: H74939206070470
• Device Lot Number: 0033946878
• 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: 10/28/2025
• Supplement Date Received by Manufacturer: 11/18/2025; 01/20/2026
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 11/22/2025; 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2024
• 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 Sex: Unknown