BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAPAQ - CERECYTE MICROCOIL

    MDR report key: 6954926 · Received October 17, 2017

    Report

    Report Number
    3013875781-2017-00007
    Event Type
    Malfunction
    Date Received
    October 17, 2017
    Date of Event
    April 8, 2017
    Report Date
    July 30, 2017
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    HCG
    UDI-DI
    00878528007036
    PMA / PMN Number
    K080437
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MFG. NAME - CODMAN & SHURTLEFF, INC. DBA DEPUY SYNTHES PRODUCTS, INC. CONCLUSION: THE DEVICE WAS RETURNED WITH ITS INNER POUCH. LABELING ON THE INNER POUCH MATCHES THE PRODUCT DOCUMENTED IN THE COMPLAINT. THE DEVICE WAS RETURNED SHEATHED. THERE ARE NO APPARENT KINKS OR BENDS IN THE DPU CORE WIRE. THE EMBOLIC COIL IS ATTACHED TO THE DPU AND CAN BE SEEN IN THE GREEN INTRODUCER. THERE IS A KINK IN THE END OF THE GREEN INTRODUCER. THE BALL TIP IS INTACT. THERE ARE KINKS IN THE EMBOLIC COIL. THE ARTICULATING JOINT IS OBSCURED IN THE GREEN INTRODUCER, BUT DOES NOT APPEAR TO BE DAMAGED. THE V-NOTCH IS INTACT. ADVANCEMENT OF THE EMBOLIC COIL THROUGH THE GREEN INTRODUCER WAS ATTEMPTED. THE EMBOLIC COIL COULD BE ADVANCED OUT OF THE GREEN INTRODUCER. THE MICROCATHETER USED IN THE REPORTED EVENT WAS NOT RETURNED OR IDENTIFIED, SO ADVANCEMENT WAS ATTEMPTED THROUGH A COMPATIBLE MICROCATHETER (PROWLER 14). THE EMBOLIC COIL ADVANCED SUCCESSFULLY THROUGH THE MICROCATHETER. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THE COMPLAINT THAT THE EMBOLIC COIL WAS IMPEDED IN THE MICROCATHETER WAS NOT CONFIRMED. THE DEVICE WAS SUCCESSFULLY ADVANCED THROUGH A COMPATIBLE MICROCATHETER. THE KINKS OBSERVED IN THE MICROCOIL ARE EVIDENCE THAT EXCESSIVE FORCE WAS APPLIED, POSSIBLY IN AN ATTEMPT TO OVERCOME RESISTANCE. WITHOUT THE RETURN OF THE MICROCATHETER, THE CAUSE OF THE COMPLAINT CANNOT BE DETERMINED. THERE IS NO CURRENT SAFETY SIGNAL IDENTIFIED RELATED TO THE REPORTED EVENT BASED ON REVIEW OF COMPLAINT HISTORY FOR THE DEVICE. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS AN INITIAL/FINAL MDR REPORT.

    Description of Event or Problem · 1

    AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING THE PROCEDURE, THE DELTAPAQ COIL (CDF10015430/ S10965) COULD NOT BE ADVANCED VIA THE MICROCATHETER, AND DURING ANALYSIS OF THE RETURNED PRODUCT, IT WAS FOUND THAT THE COIL WAS KINKED. THEY USED ANOTHER ONE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735216 DELTAPAQ - CERECYTE MICROCOIL NEUROVASCULAR EMBOLIZATION DEVICE HCG MEDOS INTERNATIONAL SARL NA S10965 00878528007036

    Patients

    Seq Age Sex Outcome Treatment
    1