BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESIDIO 18 - CERECYTE MICROCOIL

    MDR report key: 5708691 · Received June 9, 2016

    Report

    Report Number
    2954740-2016-00124
    Event Type
    Malfunction
    Date Received
    June 9, 2016
    Date of Event
    May 25, 2016
    Report Date
    June 1, 2016
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    HCG
    PMA / PMN Number
    K082739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP MDR REPORT BEING SUBMITTED FOR THIS COMPLAINT. CHANGED PMA/510K # FROM K002056 TO K082739 .

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF ONE INITIAL/FINAL MDR REPORT BEING SUBMITTED FOR THIS COMPLAINT. (B)(4). THE PRESIDIO COIL WILL NOT BE RETURNED; THEREFORE THE ROOT CAUSE OF THE DETACHMENT DIFFICULTY AND THE COILS UNRAVELING DURING REMOVAL CANNOT BE DETERMINED. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (C34416) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. SINCE THERE WAS NO EVIDENCE OF A MANUFACTURING ISSUE RELATED TO THE EVENT, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED BY A HEALTH CARE PROFESSIONAL, DURING A COIL EMBOLIZATION PROCEDURE OF AN UNRUPTURED ANEURYSM AT THE HEPATIC ARTERY THE PHYSICIAN WAS UNABLE TO DETACH A PRESIDIO COIL (PC418164730/ C34416). THE PATIENT'S VESSELS WERE MODERATELY TORTUROUS AND NOT CALCIFIED. THE PRESIDIO COIL WAS FIRST COIL FOR THE PROCEDURE CHOSEN AS THE FRAMING COIL AND THE ENPOWER CABLE (ECB00018200/P11371) AND ENPOWER DCB (LOT UNKNOWN) WERE NEWLY OPENED FOR THIS PROCEDURE. ALTHOUGH THE ELECTRICAL CHECK WITH THE ENPOWER CABLE PRIOR TO INSERTION WAS SUCCESSFUL AND THE DETACHMENT LIGHT ILLUMINATED DURING THE DETACHMENT CYCLE, WHEN THE DETACH BUTTON WAS PRESSED THE SIGNAL DID NOT BEEP AND THE MICROCOIL DID NOT DETACH. THE PHYSICIAN PRESSED THE ENPOWER DETACHMENT CONTROL BOX'S (LOT UNKNOWN) DETACH BUTTON, BUT TO NO AVAIL. ALL CONNECTIONS APPEARED TO FIT PROPERLY WITHOUT APPLICATION OF EXCESSIVE FORCE. THE CABLE WAS REPLACED WITH A NEW ONE, BUT STILL THE MICROCOIL COULD NOT BE DETACHED. THE PHYSICIAN DECIDED TO RECOVER THE PRESIDIO COIL, BUT IN THE PROCESS THE MICROCOIL GOT UNRAVELED. THE PRESIDIO WAS WITHDRAWN TOGETHER WITH THE MICROCATHETER (TYPE/LOT UNKNOWN). THE MICROCATHETER WAS RE-INSERTED AND ANOTHER PRESIDIO 18 (LOT UNKNOWN) WAS SUCCESSFULLY DELIVERED AND DETACHED WITH THE REPLACEMENT CABLE AND A NEW DCB. AFTER ADDING A DELTAMAXX (LOT UNKNOWN), THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES. THERE WERE NO PATIENT INJURIES OR COMPLICATIONS; HOWEVER THE PROCEDURE WAS DELAYED FOR 15 MINUTES DUE TO THE EVENT. THE COMPLAINT PRODUCTS WERE NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND THE CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIMES. NO VISIBLE DAMAGES WERE NOTED ON THE PRODUCTS PRIOR TO AND AFTER THE EVENT. THE COMPLAINED PRODUCTS HAVE ALREADY BEEN DISPOSED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365740 PRESIDIO 18 - CERECYTE MICROCOIL CNV DCS COILS HCG MEDOS INTERNATIONAL SARL C34416

    Patients

    Seq Age Sex Outcome Treatment
    1