BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELIPAQ 10 - PLATINUM MICROCOIL

    MDR report key: 4086714 · Received September 12, 2014

    Report

    Report Number
    1226348-2014-00576
    Event Type
    Malfunction
    Date Received
    September 12, 2014
    Date of Event
    August 15, 2011
    Report Date
    August 17, 2011
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K022420
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, THE EXACT ROOT CAUSE OF THE PROBLEM REPORTED COULD NOT BE DETERMINED. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY RELEVANT DISCREPANCIES, DESIGN OR QUALITY CONCERNS. A SEARCH OF OUR FIELD SURVEILLANCE DATABASE YIELDED NO OTHER COMPLAINTS OF THIS TYPE WITH THIS LOT. WITH THE INFORMATION AVAILABLE AND WITHOUT THE PRODUCT AVAILABLE FOR ANALYSIS, THE COMPLAINT COULD NOT BE CONFIRMED. INSPECTIONS ARE IN PLACE TO PREVENT DAMAGED PRODUCTS FROM LEAVING THE FACILITY AND THE DHR REVIEW CONFIRMED THAT THE PRODUCT MET SPECIFICATIONS. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. IT IS DIFFICULT TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT BASED ON THE LIMITED INFORMATION AVAILABLE.

    Description of Event or Problem · 1

    THE COMPLAINT RECEIVED SATES THAT DURING USE THE HELIPAQ 10 PLATINUM MICROCOIL 3 MM X 10 CM (HSR10031020 / F69717) HAD DETACHMENT DIFFICULTY. COIL REMOVED FROM PLASTIC HOLDER AS PER USUAL PREPARATION. COIL TESTED BEFORE BEING USED IN PATIENT AND PASSED. COIL POSITIONED AND DETACHMENT BOX SWITCHED ON. COIL WOULD NOT DETACH UNTIL THE DETACHMENT BUTTON HAD BEEN PRESSED FOUR TIMES. OTHER COILS USED FIRST WERE AXIUMS 7 X 30MM QC, LOT 7672037; 5 X 15 PC5-15-3D, LOT 9381360; 5 X 15MM, LOT 9419603; 4 X 12CM, LOT 9430619; NC 4 X 10, LOT 9222858 FOLLOWED BY HSR 100310-20, LOT69717 WHERE THE BUTTON WAS PRESSED, BUT DID NOT DETACH AND FELT CONNECTED, BUT EVENTUALLY DETACHED AFTER PULLING THE DPU BACK THE COIL DID DETACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564360 HELIPAQ 10 - PLATINUM MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA F69717

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK CABLE AND DETACHMENT BOX