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

Model Number	H74939206070470
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b - pro code (product code): fge, lit.E1 - initial reporter facility name: (b)(6).E1 - initial reporter address 1: (b)(6).E1 - initial reporter phone: (b)(6).G4 - premarket / 510(k) #: k112697, k112701, k141521.
Event or Problem Description
It was reported that balloon burst occurred.The patient underwent percutaneous artificial arteriovenous fistula balloon dilatation in the left forearm and intravenous thrombolysis in the upper limb under local anesthesia with b-ultrasound positioning.A 7.0 x40, 75cm charger balloon was punctured successfully under the guidance of b ultrasound.However, balloon burst before reaching the bursting pressure.The device was removed and the procedure was completed with another of the same device.There were no patient complications as a result of this event.And the patient condition following procedure was stable.
Event or Problem Description
It was reported that balloon burst occurred.The patient underwent percutaneous artificial arteriovenous fistula balloon dilatation in the left forearm and intravenous thrombolysis in the upper limb under local anesthesia with b-ultrasound positioning.A 7.0 x40, 75cm charger balloon was punctured successfully under the guidance of b ultrasound.However, balloon burst before reaching the bursting pressure.The device was removed and the procedure was completed with another of the same device.There were no patient complications as a result of this event.And the patient condition following procedure was stable.It was further reported that the balloon ruptured after the pressure pump released pressure during the first inflation at 12 atmospheres for 15 seconds.
Additional Manufacturer Narrative
D2b - pro code (product code): fge, lit e1 - initial reporter facility name: (b)(6).E1 - initial reporter address 1: (b)(6).E1 - initial reporter phone: (b)(6).G4 - premarket / 510(k) #: k112697, k112701, k141521.
Additional Manufacturer Narrative
D2b - pro code (product code): fge, lit.E1 - initial reporter facility name: (b)(6).G4 - premarket / 510(k) #: k112697, k112701, k141521.Device evaluated by mfr: the charger device was returned to our post market quality assurance laboratory.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 35mm in length and extended from a position 9mm distal of the proximal markerband to 6mm distal of the distal 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.This concludes the product analysis.
Event or Problem Description
It was reported that balloon burst occurred.The patient underwent percutaneous artificial arteriovenous fistula balloon dilatation in the left forearm and intravenous thrombolysis in the upper limb under local anesthesia with b-ultrasound positioning.A 7.0 x40, 75cm charger balloon was punctured successfully under the guidance of b ultrasound.However, balloon burst before reaching the bursting pressure.The device was removed and the procedure was completed with another of the same device.There were no patient complications as a result of this event.And the patient condition following procedure was stable.It was further reported that the balloon ruptured after the pressure pump released pressure during the first inflation at 12 atmospheres for 15 seconds.
Additional Manufacturer Narrative
Updated a1: patient identifier d2b - pro code (product code): fge, lit.E1 - initial reporter facility name: (b)(6).E1 - initial reporter address 1: (b)(6).E1 - initial reporter phone: (b)(6).G4 - premarket / 510(k) #: k112697, k112701, k141521.Device evaluated by mfr: the charger device was returned to our post market quality assurance laboratory.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 35mm in length and extended from a position 9mm distal of the proximal markerband to 6mm distal of the distal 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.This concludes the product analysis.
Event or Problem Description
It was reported that balloon burst occurred.The patient underwent percutaneous artificial arteriovenous fistula balloon dilatation in the left forearm and intravenous thrombolysis in the upper limb under local anesthesia with b-ultrasound positioning.A 7.0 x40, 75cm charger balloon was punctured successfully under the guidance of b ultrasound.However, balloon burst before reaching the bursting pressure.The device was removed and the procedure was completed with another of the same device.There were no patient complications as a result of this event.And the patient condition following procedure was stable.It was further reported that the balloon ruptured after the pressure pump released pressure during the first inflation at 12 atmospheres for 15 seconds.Device evaluated by mfr: the charger device was returned to our post market quality assurance laboratory.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 35mm in length and extended from a position 9mm distal of the proximal markerband to 6mm distal of the distal 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.This concludes the product analysis.It was further reported that the patient did not have challenging anatomy and the procedural factors did not contribute to the 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 22914031
• Report Number: 2124215-2025-60649
• Device Sequence Number: 21137552
• Product Code: FGE
• UDI-Device Identifier: 08714729804536
• UDI-Public: (01)08714729804536(17)260821(10)32264531
• 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,Followup
• Report Date (Section B): 03/25/2026

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 Expiration Date: 08/21/2026
• Device Model Number: H74939206070470
• Device Catalogue Number: H74939206070470
• Device Lot Number: 0032264531
• 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: 08/07/2025
• Supplement Date Received by Manufacturer: 09/07/2025; 01/05/2026; 02/24/2026
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 09/29/2025; 01/26/2026; 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2023
• 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: 65 YR
• Patient Sex: Male