BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPYGLASS DISCOVER DIGITAL CATHETER

    MDR report key: 11745317 · Received April 29, 2021

    Report

    Report Number
    3005099803-2021-01930
    Event Type
    Malfunction
    Date Received
    April 29, 2021
    Date of Event
    April 8, 2021
    Report Date
    April 29, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FBN
    UDI-DI
    08714729994183
    PMA / PMN Number
    K200483
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMMON DEVICE NAME (PRODUCT CODE): NTN. (B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE PROBLEM ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYGLASS DISCOVER DIGITAL CATHETER WAS USED DURING A PERCUTANEOUS CHOLANGIOSCOPY PROCEDURE PERFORMED IN THE GALLBLADDER ON (B)(6) 2021. DURING THE PROCEDURE, THE IMAGE OF THE SPY DISCOVER CATHETER STARTED TO SHOW SOME FEEDBACK OR BREAKING UP ON THE SCREEN AND WAS LOST APPROXIMATELY 20 MINUTES INTO THE PROCEDURE. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. IT WAS REPORTED THAT THE PROCEDURE HAS NOT BEEN RESCHEDULED YET. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644107 SPYGLASS DISCOVER DIGITAL CATHETER FBN BOSTON SCIENTIFIC CORPORATION M00546780 27006205 08714729994183

    Patients

    Seq Age Sex Outcome Treatment
    1