BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPYGLASS DISCOVER DIGITAL CATHETER

    MDR report key: 12933687 · Received December 6, 2021

    Report

    Report Number
    3005099803-2021-06456
    Event Type
    Malfunction
    Date Received
    December 6, 2021
    Date of Event
    November 22, 2021
    Report Date
    December 6, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FBN
    UDI-DI
    08714729994183
    PMA / PMN Number
    K200483
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (PRODUCT CODE): NTN. (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A PROBLEM ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYGLASS DISCOVER DIGITAL CATHETER WAS USED DURING A PERCUTANEOUS ENDOSCOPY PROCEDURE PERFORMED IN THE GALLBLADDER ON (B)(6) 2021. DURING THE PROCEDURE, THE DISCOVER SCOPE BEGAN TO LOSE VISUALIZATION TOWARD THE END OF THE PROCEDURE. THE PHYSICIAN ATTEMPTED WITH AN ALTERNATIVE NON-SPY DEVICE AND WAS ULTIMATELY NOT ABLE TO REMOVE THE STONE. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1831193 SPYGLASS DISCOVER DIGITAL CATHETER FBN BOSTON SCIENTIFIC CORPORATION M00546780 0028133618 08714729994183

    Patients

    Seq Age Sex Outcome Treatment
    1 Male