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

Model Number	H74939206031010
Medical Device Problem Codes	Entrapment of Device (1212); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon became stuck with the wire.The occluded target lesion was located in the non-tortuous and moderately calcified superficial femoral artery (sfa).A 3.0 x100, 135cm charger balloon was selected for angioplasty.During the procedure, the balloon was successfully prepped and loaded into a non-boston scientific (bsc) wire, then advanced to the lesion.The balloon was inflated and fully deflated successfully.However, the balloon would not move when attempting to remove it from the wire.The hub of balloon began to elongate or stretch from pulling to get it to back off the wire.As a result, both the balloon and wire had to be pulled out as a single unit to remove them from the patient.The procedure was completed using an alternate device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the complaint device was received for product analysis.The recommended guidewire size for this device is 0.035" as per specification.The guidewire used by the customer could not be removed from the device due to shaft damage.The size of guidewire used by the customer was measured at 0.0335" which is within specification.A visual and tactile examination found the shaft of the device to be severely stretched/buckled beginning at the strain relief and extending approximately 20mm distally along the shaft.No other issues were found with the shaft.A visual examination identified that the balloon was not folded which indicates that it was subjected to positive pressure.No issues were identified with the balloon material.A visual examination of the markerbands found no issues.A visual and tactile examination found no damage or issues with the tip of the device.This concludes the product analysis.

• 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 ; 6128757234
• MDR Report Key: 21305826
• Report Number: 2124215-2025-03660
• Device Sequence Number: 12783448
• Product Code: LIT
• UDI-Device Identifier: 08714729803898
• UDI-Public: 08714729803898
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K112701
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/04/2025

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: 06/12/2026
• Device Model Number: H74939206031010
• Device Catalogue Number: H74939206031010
• Device Lot Number: 0031806455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE - GLIDEWIRE ADVANTAGE
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Race: White