BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAXTRASOFT COIL

    MDR report key: 7062618 · Received November 28, 2017

    Report

    Report Number
    3013875781-2017-00039
    Event Type
    Malfunction
    Date Received
    November 28, 2017
    Date of Event
    September 6, 2017
    Report Date
    September 6, 2017
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    HCG
    UDI-DI
    10886704077336
    PMA / PMN Number
    K150319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT MET MDR REPORTING CRITERIA ON 11/28/2017 WHEN ANALYSIS FOUND THAT THE COIL WAS KINKED AND STRETCHED. CONCOMITANT MEDICAL PRODUCTS: A SHEATH INTRODUCER (SUPERSHEATH, MEDIKIT), A GUIDEWIRE (CHIKAI 10, ASAHI INTECC), A GUIDING CATHETER (7FR FUBUKI, ASAHI INTECC), A MICRO CATHETER (HEADWAY, TERUMO) AND AN ENPOWER WERE ALSO USED FOR THIS PROCEDURE. CUSTOMER INFORMATION COULD NOT BE PROVIDED. THE FACILITY WAS (B)(6) AFFILIATED HOSPITAL. MFG NAME - CODMAN & SHURTLEFF, INC. DBA DEPUY SYNTHES PRODUCTS, INC CONCLUSION: THE DEVICE (LOT S12011), WAS RETURNED WITH THE LABEL FROM ITS INNER POUCH. THE LABEL MATCHES THE PRODUCT DOCUMENTED IN THE COMPLAINT. THERE IS BLOOD IN THE GREEN INTRODUCER AND TRANSLUCENT INTRODUCER SHEATH. THE EMBOLIC COIL IS LOCATED IN THE TRANSLUCENT INTRODUCER SHEATH. THERE IS A SLIGHT BEND IN THE DEVICE POSITIONING UNIT (DPU) CORE WIRE APPROXIMATELY 123 CM FROM THE PROXIMAL END. THE BALL TIP IS INTACT. THE PROXIMAL END OF THE EMBOLIC COIL IS KINKED, STRETCHED, AND FOLDED OVER ON ITSELF. THE CONDITION OF THE ARTICULATING JOINT AND RESISTANCE HEATING (RH) COIL ARE OBSCURED BY THE DAMAGED EMBOLIC COIL. THE V-NOTCH OF THE RESHEATHING TOOL IS UNDAMAGED. ADVANCEMENT CANNOT BE TESTED BECAUSE OF THE DAMAGE TO THE EMBOLIC COIL. 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 THERE WAS RESISTANCE OR FRICTION DURING ADVANCEMENT CANNOT BE CONFIRMED. THE EMBOLIC COIL CANNOT BE ADVANCED PAST ITS CURRENT LOCATION IN THE TRANSLUCENT INTRODUCER SHEATH DUE TO DAMAGE, SO ADVANCEMENT INTO OR THROUGH A MICROCATHETER CANNOT BE TESTED. THE DAMAGED EMBOLIC COIL AND BEND DPU CORE WIRE ARE INDICATIVE OF APPLICATION OF EXCESSIVE FORCE, POSSIBLY IN AN ATTEMPT TO OVERCOME RESISTANCE. RESISTANCE COULD HAVE BEEN ENCOUNTERED AS A RESULT OF INSUFFICIENT FLUSH. THE PRESENCE OF BLOOD IN THE GREEN INTRODUCER AND TRANSLUCENT INTRODUCER SHEATH SUGGESTS THAT AN INSUFFICIENT FLUSH WAS MAINTAINED. THE IFU STATES THAT CONTINUOUS INFUSION OF AN APPROPRIATE FLUSH SOLUTION IS REQUIRED FOR OPTIMAL PERFORMANCE, AND ALSO INDICATES THAT THE FLUSH SHOULD BE VERIFIED IN THE EVENT OF RESISTANCE. INSUFFICIENT FLUSH ALLOWS BLOOD TO BACK-FLOW INTO THE MICROCATHETER, WHICH CAN CAUSE RESISTANCE. THERE IS NO CURRENT SAFETY SIGNAL IDENTIFIED RELATED TO THE REPORTED EVENTS BASED ON REVIEWS OF COMPLAINT HISTORIES FOR THE DEVICES. 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 A CASE OF SHUNTING TO THE CS OPPOSITE FROM THE RIGHT MMA, THERE WAS RESISTANCE BETWEEN 2 DELTAXTRASOFT DEVICES (DLX100206/ S12442 AND DLX100206/ S12011) AND A HEADWAY MICROCATHETER. DURING PRODUCT ANALYSIS, IT WAS FOUND THAT BOTH COILS WERE KINKED AND STRETCHED. A GUIDING CATHETER WAS INSERTED AND THE MICROCATHETER WAS ACCESSED TO THE CS. AFTER THAT, AN ATTEMPT TO INSERT ONE OF THE COMPLAINT COILS; HOWEVER, THE COIL COULD NOT BE ADVANCED AT THE HUB PORTION OF THE CATHETER. THE COIL WAS REMOVED ONCE AND THE DEVICE WAS FLUSHED, BUT THE COIL COULD NOT BE INSERTED INTO THE CATHETER. THEREFORE, THE COIL WAS REPLACED WITH THE SECOND COMPLAINT COIL, BUT THE SAME ISSUE OCCURRED. THE COIL WAS REPLACED WITH A COMPETITIVE COIL AND THE PROCEDURE SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THERE WAS ALSO NO PATIENT INJURY / COMPLICATION REPORTED. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND THE CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIME. NO VISIBLE DEFECT/DAMAGE WAS NOTED ON THE PRODUCTS PRIOR TO THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842617 DELTAXTRASOFT COIL NEUROVASCULAR EMBOLIZATION DEVICE HCG MEDOS INTERNATIONAL SARL NA S12011 10886704077336

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR