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

Model Number	H74939206100470
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b: pro code (product code): fge, lit.G4: premarket / 510(k) #: k112697, k112701, k141521.
Event or Problem Description
It was reported that balloon burst occurred.The target lesion was situated in the peripheral artery.A 10.0 x 40 mm, 75 cm charger balloon catheter was selected for dilation.The procedure commenced with a successful angiography performed via a 6 french sheath, and the lesion was successfully crossed with a guidewire.Additionally, intravascular ultrasound (ivus) was effectively conducted to further assess the lesion.However, during the preparation for balloon dilation, a leak was detected at the balloon package opening.This issue led to the balloon rupturing upon the first inflation attempt.Consequently, the planned dilation could not be completed with the initial device.The procedure was subsequently adapted, and an alternative device was utilized to achieve the desired outcome.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
D2b: pro code (product code): fge, lit.G4: premarket / 510(k) #: k112697, k112701, k141521.Device evaluated by mfr: the charger 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 14 atmospheres as charger specification (b)(4).The returned device was attached to an encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole located approximately 6mm distal from the proximal markerband.Inflation of the device is not possible due to the balloon pinhole.A visual examination of the markerbands identified no issues.A visual and tactile examination identified no kinks or damage to the shaft.A visual and tactile examination identified no damage to the tip of the device.
Event or Problem Description
It was reported that balloon burst occurred.The target lesion was situated in the peripheral artery.A 10.0 x 40 mm, 75 cm charger balloon catheter was selected for dilation.The procedure commenced with a successful angiography performed via a 6 french sheath, and the lesion was successfully crossed with a guidewire.Additionally, intravascular ultrasound (ivus) was effectively conducted to further assess the lesion.However, during the preparation for balloon dilation, a leak was detected at the balloon package opening.This issue led to the balloon rupturing upon the first inflation attempt.Consequently, the planned dilation could not be completed with the initial device.The procedure was subsequently adapted, and an alternative device was utilized to achieve the desired outcome.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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 21688544
• Report Number: 2124215-2025-17970
• Device Sequence Number: 8774542
• Product Code: FGE
• UDI-Device Identifier: 08714729803799
• UDI-Public: 08714729803799
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2025

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: H74939206100470
• Device Catalogue Number: H74939206100470
• Device Lot Number: 0033063854
• 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: 02/27/2025
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2023
• 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: 72 YR
• Patient Sex: Male