BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPYGLASS DISCOVER DIGITAL CATHETER

    MDR report key: 14627437 · Received June 7, 2022

    Report

    Report Number
    3005099803-2022-03101
    Event Type
    Malfunction
    Date Received
    June 7, 2022
    Date of Event
    May 14, 2022
    Report Date
    June 13, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FBN
    UDI-DI
    08714729994183
    PMA / PMN Number
    K200483
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (PRODUCT CODE): NTN. INITIAL REPORTER ADDRESS 1):(B)(6). (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.

    Additional Manufacturer Narrative · 0

    BLOCK D2B (PRODUCT CODE): NTN BLOCK E1 (INITIAL REPORTER ADDRESS 1): (B)(6). BLOCK H6 (EVALUATION CONCLUSION CODES): CONCLUSION CODE D17 IS BEING USED IN LIEU OF AN ADEQUATE CONCLUSION CODE FOR DEVICE NOT RETURNED. BLOCK H6 (IMPACT CODES): IMPACT CODE F1001 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF ABORTED/CANCELLED PROCEDURE. BLOCK H10: 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. BLOCK H11: ADDITIONAL INFORMATION B5.

    Description of Event or Problem · 0

    NOTE: THIS REPORT PERTAINS TO SPY DISCOVER CATHETER AND SPY DISCOVER CONTROLLER USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPY DISCOVER CATHETER AND SPY DISCOVER CONTROLLER WERE USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY WITH COMMON BILE DUCT EXPLORATION PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, VISUALIZATION WAS LOST. EACH TIME THEY PLUGGED THE DEVICE IN, VISUALIZATION WOULD POP UP FOR A MOMENT THEN THE IMAGE WAS LOST. THEY TRIED TO PLUGGED THE DEVICE IN AND OUT, SWITCHED MONITORS, BUT NOTHING WORKED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    NOTE: THIS REPORT PERTAINS TO SPY DISCOVER CATHETER AND SPY DISCOVER CONTROLLER USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPY DISCOVER CATHETER AND SPY DISCOVER CONTROLLER WERE USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY WITH COMMON BILE DUCT EXPLORATION PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, VISUALIZATION WAS LOST. EACH TIME THEY PLUGGED THE DEVICE IN, VISUALIZATION WOULD POP UP FOR A MOMENT THEN THE IMAGE WAS LOST. THEY TRIED TO PLUGGED THE DEVICE IN AND OUT, SWITCHED MONITORS, BUT NOTHING WORKED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED ON JUNE 08, 2022: IT WAS REPORTED THAT THE CONTROLLER HAS BEEN TESTED SINCE THIS EVENT AND WORKED AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184745 SPYGLASS DISCOVER DIGITAL CATHETER FBN BOSTON SCIENTIFIC CORPORATION M00546780 08714729994183

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown