BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COREDX?

    MDR report key: 22560770 · Received July 21, 2025

    Report

    Report Number
    3005099803-2025-03416
    Event Type
    Malfunction
    Date Received
    July 21, 2025
    Date of Event
    June 27, 2025
    Report Date
    November 28, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EOQ
    UDI-DI
    08714729971054
    PMA / PMN Number
    K183085
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF DEVICE CODE A051104 CAPTURES THE REPORTABLE EVENT OF JAWS FAILURE TO CLOSE.

    Additional Manufacturer Narrative · 0

    BLOCK H2: ADDITIONAL INFORMATION: BLOCK B5 HAS BEEN UPDATED BASED ON THE ADDITIONAL INFORMATION PROVIDED ON NOVEMBER 06, 2025. BLOCK H6: IMDRF DEVICE CODE A051104 CAPTURES THE REPORTABLE EVENT OF JAWS FAILURE TO CLOSE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A COREDX BIOPSY FORCEPS WAS USED IN THE COMMON BILE DUCT DURING A PERCUTANEOUS CHOLANGIOSCOPY WITH BIOPSY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, IT WAS NOTED THAT THE JAWS OF THE FORCEPS WOULD NOT CLOSE. THE FORCEPS WERE REMOVED TOGETHER WITH THE SPYGLASS DISCOVERY SCOPE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A COREDX BIOPSY FORCEPS WAS USED IN THE COMMON BILE DUCT DURING A PERCUTANEOUS CHOLANGIOSCOPY WITH BIOPSY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, IT WAS NOTED THAT THE JAWS OF THE FORCEPS WOULD NOT CLOSE. THE FORCEPS WERE REMOVED TOGETHER WITH THE SPYGLASS DISCOVERY SCOPE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. ACCORDING TO THE INFORMATION RECEIVED ON NOVEMBER 06, 2025; THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2751626 COREDX? BRONCHOSCOPE (FLEXIBLE OR RIGID) EOQ BOSTON SCIENTIFIC CORPORATION M00515220 0034927002 08714729971054

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown