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

Model Number	H74939206080870
Medical Device Problem Codes	Inflation Problem (1310); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on the device analysis completed on 17feb2025.The 80% stenosed target lesion was located in the severely tortuous iliac vein.A 8.0 x80, 75cm charger balloon catheter was advanced for dilatation.During the procedure, the pressure pump was utilized to inflate the device to 10 atmospheres however, it failed to inflate.The physician subsequently withdrew the intact product from the patients body and replaced it with an identical device to successfully complete the procedure.There were no patient complications reported.However, the device analysis revealed a pinhole.
Additional Manufacturer Narrative
The 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.A balloon pinhole was noted located approximately 1mm proximal of the proximal markerband.The rated burst pressure for this device is 18 atmospheres.A visual and tactile examination found the shaft of the device to be kinked at more than one location.A visual and tactile examination found no damage to the tip of the device.A visual examination observed no issues with the markerbands of the device.Both markerbands were undamaged in the correct position on the device.

• 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: 21540698
• Report Number: 2124215-2025-13881
• Device Sequence Number: 15228701
• Product Code: FGE
• UDI-Device Identifier: 08714729804703
• UDI-Public: 08714729804703
• 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
• Report Date (Section B): 03/06/2025

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 Expiration Date: 06/22/2026
• Device Model Number: H74939206080870
• Device Catalogue Number: H74939206080870
• Device Lot Number: 0031878875
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2023
• 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: 69 YR
• Patient Sex: Unknown