MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Charger?; stents, drains and dilators for the biliary ducts

Model Number	H74939206100870
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the balloon could not be withdrawn requiring additional intervention.A 10.0 x80, 75cm charger balloon catheter was advanced for dilatation.During the venous balloon dilatation procedure, the first inflation was completed successfully.However, during the second inflation attempt, the balloon could not be withdrawn.Attempts to advance the device further were also unsuccessful.The balloon was pulled back along the vessel to the sheath entry site.The device was then removed through the sheath, and a needle was used to puncture the balloon to facilitate complete extraction.The procedure was completed with another of same device.There were no patient complications as a result of this event.The patient was stable post procedure.
Additional Manufacturer Narrative
D2b: pro code: (product code): fge, lit.E1: initial reporter phone: (b)(6).G4: premarket / 510(k): k112697, k112701, k141521.Good faith effort attempts were made to try and retrieve the device status and additional details regarding the reported event, but further information was unable to be obtained.

• 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 ; +1(612)875-7234
• MDR Report Key: 50841702
• Report Number: 2124215-2026-50192
• Device Sequence Number: 10301448
• Product Code: FGE
• UDI-Device Identifier: 08714729803812
• UDI-Public: (01)08714729803812(17)280505(10)36451938
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K112697
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H74939206100870
• Device Catalogue Number: H74939206100870
• Device Lot Number: 0036451938
• 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: 08/25/2026
• Initial Report FDA Received Date: 09/21/2026
• Date Device Manufactured: 05/06/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown