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

Model Number	H74939206080410
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b: pro code: (product code): fge, lit.E1: (b)(6).G4: premarket / 510(k): k112697, k112701, k141521.Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reported that a balloon rupture occurred.The patient underwent thoracic endovascular aortic repair under general anesthesia.Vascular access was obtained under b-ultrasound guidance, and an 8.0 x 40, 135 cm charger balloon catheter was advanced to perform the fenestration procedure.During the procedure, the balloon ruptured before the rated burst pressure was reached.The procedure was completed with another of same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
D2b: pro code: (product code): fge, lit.E1: (b)(6).G4: premarket / 510(k): k112697, k112701, k141521.Investigation results: device evaluated by mfr: the 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.The rated burst pressure for this device is 18 atmospheres as charger.The returned device was attached to an inflation unit.Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole located approximately 6mm proximal from the distal markerband, which confirms the event.No other issues were identified during the product analysis.Dhr (device history record) review: 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.Risk review: a risk review performed for the charger device confirmed that the event of balloon- material rupture was a known event defined in the products 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 concludes the most probable root cause as adverse event related to procedure.
Event or Problem Description
It was reported that a balloon rupture occurred.The patient underwent thoracic endovascular aortic repair under general anesthesia.Vascular access was obtained under b-ultrasound guidance, and an 8.0 x 40, 135 cm charger balloon catheter was advanced to perform the fenestration procedure.During the procedure, the balloon ruptured before the rated burst pressure was reached.The procedure was completed with another of same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
D2b: pro code: (product code): fge, lit.E1: initial reporter facility name: (b)(6).E1: initial reporter phone: (b)(6).G4: premarket / 510(k): k112697, k112701, k141521.Investigation results: device analysis findings: upon receipt at our post market quality assurance laboratory, this charger device was examined.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The rated burst pressure for this device is 18 atmospheres as charger.The returned device was attached to an inflation unit.Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole located approximately 6mm proximal from the distal markerband, which confirms the event.No other issues were identified during the product analysis.Dhr (device history record) review 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 balloon- material rupture was a known event defined in the products 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 concludes the most probable root cause as adverse event related to procedure.
Event or Problem Description
It was reported that a balloon rupture occurred.The patient underwent thoracic endovascular aortic repair under general anesthesia.Vascular access was obtained under b-ultrasound guidance, and an 8.0 x 40, 135 cm charger balloon catheter was advanced to perform the fenestration procedure.During the procedure, the balloon ruptured before the rated burst pressure was reached.The procedure was completed with another of same device.There were no patient complications as a result of this 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: 24240859
• Report Number: 2124215-2026-05890
• Device Sequence Number: 13346781
• Product Code: FGE
• UDI-Device Identifier: 08714729804666
• UDI-Public: (01)08714729804666(17)280523(10)36600191
• 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): 05/11/2026

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: H74939206080410
• Device Catalogue Number: H74939206080410
• Device Lot Number: 0036600191
• 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: 01/12/2026
• Supplement Date Received by Manufacturer: 03/12/2026; 04/21/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 04/01/2026; 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2025
• 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
• Patient Age: 60 YR
• Patient Sex: Male