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

Model Number	H74939206080470
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A2 - age at time of event: 18 years or older.G4: premarket / 510(k): k112697, k112701, k141521.E1: initial reporter phone: (b)(6).
Event or Problem Description
It was reported that the device became entrapped on the guidewire.The 70% stenosed target lesion was located in the non-tortuous and non-calcified iliac vein.A non-boston scientific guidewire was used during the procedure.An 8.0 x 40 mm, 75 cm charger balloon catheter was advanced for dilatation.During the procedure, the balloon catheter and guidewire became stuck together and could not be withdrawn.As a result, the balloon catheter and guidewire had to be removed together as one unit.The procedure was completed with another of the same device.There were no patient complications as a result of this event, and the patient was in stable condition following the procedure.
Additional Manufacturer Narrative
A2 - age at time of event: 18 years or older.G4: premarket / 510(k): k112697, k112701, k141521.E1: initial reporter phone: (b)(6).Investigation results: device analysis findings: the device was returned loaded on to the customers guidewire.A visual examination identified that the balloon had been subjected to positive pressure.No damage or issues were found with the balloon, shaft, tip, or markerbands of the device.The device was successfully removed from the customers guidewire without issue.No issues were identified during the product analysis.Device history record: it was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed that the content was sufficient and did not contribute to the reported event; therefore, no updates are required to the document at this time.Risk review: a risk review performed for the charger device confirmed that the event of entrapment of device was defined in the product's risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of no problem detected.
Event or Problem Description
It was reported that the device became entrapped on the guidewire.The 70% stenosed target lesion was located in the non-tortuous and non-calcified iliac vein.A non-boston scientific guidewire was used during the procedure.An 8.0 x 40 mm, 75 cm charger balloon catheter was advanced for dilatation.During the procedure, the balloon catheter and guidewire became stuck together and could not be withdrawn.As a result, the balloon catheter and guidewire had to be removed together as one unit.The procedure was completed with another of the same device.There were no patient complications as a result of this event, and the patient was in stable condition following the procedure.

• 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: 23773450
• Report Number: 2124215-2025-86792
• Device Sequence Number: 9584271
• Product Code: FGE
• UDI-Device Identifier: 08714729804673
• UDI-Public: (01)08714729804673(17)270920(10)34890787
• 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
• Report Date (Section B): 04/02/2026

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: H74939206080470
• Device Catalogue Number: H74939206080470
• Device Lot Number: 0034890787
• 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: 11/17/2025
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE: TERUMO.; GUIDEWIRE: TERUMO.
• Patient Sex: Unknown