BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTIPAQ - PLATINUM MICROCOIL

    MDR report key: 6947548 · Received October 13, 2017

    Report

    Report Number
    1226348-2017-00173
    Event Type
    Malfunction
    Date Received
    October 13, 2017
    Date of Event
    July 19, 2017
    Report Date
    July 24, 2017
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    HCG
    UDI-DI
    00878528001553
    PMA / PMN Number
    K022420
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MFG NAME - CODMAN & SHURTLEFF, INC. DBA DEPUY SYNTHES PRODUCTS, INC. CONCLUSION: THE DEVICE WAS RETURNED IN ITS INNER POUCH. THE LABELING ON THE POUCH MATCHES THE PRODUCT DOCUMENTED IN THE COMPLAINT. THE DEVICE IS FULLY UNSHEATHED. THERE APPEARS TO BE BLOOD ON THE EMBOLIC COIL, WHICH IS TIGHTLY WRAPPED AROUND THE DPU CORE WIRE. THE RE-SHEATHING TOOL HAS BEEN ADVANCED ALL THE WAY TO THE GREEN INTRODUCER. THE EMBOLIC COIL WAS GENTLY DISENTANGLED FROM THE DPU CORE WIRE. THERE ARE BENDS IN THE DPU CORE WIRE AT APPROXIMATELY 45 CM, 51 CM, AND 80 CM. THE PROXIMAL END OF THE EMBOLIC COIL IS STRETCHED. THERE WAS BLOOD ON THE DISTAL END OF THE EMBOLIC COIL. THE BALL TIP WAS INTACT. THE ARTICULATING JOINT HAD BEEN DAMAGED. THERE IS NO INDICATION OF BLOOD IN THE GREEN INTRODUCER OR THE TRANSLUCENT INTRODUCER SHEATH. THE V-NOTCH WAS UNDAMAGED. AN ATTEMPT WAS MADE TO RE-SHEATH THE EMBOLIC COIL TO ATTEMPT ADVANCING IT THROUGH A MICROCATHETER. WHEN THE RE-SHEATHING TOOL PASSED OVER THE FIRST BEND IN THE DPU CORE WIRE THE CORE WIRE COULD NOT RE-SHEATH AND PROTRUDED FROM THE TRANSLUCENT INTRODUCER SHEATH. ADVANCEMENT THROUGH A MICROCATHETER COULD NOT BE ATTEMPTED. 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 COULD NOT BE CONFIRMED. ADVANCEMENT COULD NOT BE ATTEMPTED BECAUSE THE COIL COULD NOT BE RE-SHEATHED. WHILE THE EXACT CIRCUMSTANCES ARE UNKNOWN, THE EVIDENCE OF THE STRETCHED COIL AND THE BENDS IN THE DPU CORE WIRE INDICATE THAT EXCESSIVE FORCE WAS APPLIED, POSSIBLY IN AN ATTEMPT TO OVERCOME RESISTANCE. IN ADDITION, THE PRESENCE OF BLOOD AT THE DISTAL END OF THE MICROCATHETER 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. THIS IS AN INITIAL/FINAL MDR.

    Description of Event or Problem · 1

    AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION AT AN UNKNOWN LOCATION, AN ULTIPAQ COIL (FSR10020820/ S10351) COULD NOT BE PLACED INTO THE ENTRANCE OF AN UNSPECIFIED CATHETER AND DURING PRODUCT ANALYSIS, IT WAS DETERMINED THAT THE COIL WAS STRETCHED. THE SAME TYPE COIL ADVANCED THROUGH THE SAME CATHETER AFTERWARD. THERE WAS NO POTENTIAL ADVERSE EVENT TO THE PATIENT AND THE PROCEDURE WAS DELAY 5 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727130 ULTIPAQ - PLATINUM MICROCOIL NEUROVASCULAR EMBOLIZATION DEVICE HCG MEDOS INTERNATIONAL SARL NA S10351 00878528001553

    Patients

    Seq Age Sex Outcome Treatment
    1