BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAPAQ - CERECYTE MICROCOIL

    MDR report key: 6990197 · Received October 31, 2017

    Report

    Report Number
    3013875781-2017-00020
    Event Type
    Malfunction
    Date Received
    October 31, 2017
    Date of Event
    January 30, 2017
    Report Date
    August 11, 2017
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    HCG
    UDI-DI
    00878528007210
    PMA / PMN Number
    K080437
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT MET MDR REPORTING CRITERIA ON 10/31/2017 WHEN ANALYSIS FOUND COIL DAMAGE. MFG NAME CODMAN & SHURTLEFF, INC. DBA DEPUY SYNTHES PRODUCTS, INC. CONCLUSION: THE DEVICE WAS RETURNED WITH ITS INNER POUCH. THE LABELING ON THE INNER POUCH MATCHES THE PRODUCT DOCUMENTED IN THE COMPLAINT. THE DISTAL END OF THE EMBOLIC COIL IS LOCATED IN THE TRANSLUCENT INTRODUCER SHEATH. THE PROXIMAL END OF THE EMBOLIC COIL AND THE DEVICE POSITIONING UNIT (DPU) ARE PROTRUDED FROM THE SKIVE OF THE TRANSLUCENT INTRODUCER SHEATH. THE PROXIMAL END OF THE EMBOLIC COIL APPEARS TO BE STRETCHED. THERE IS A SLIGHT BEND IN THE DPU CORE WIRE APPROXIMATELY 8 CM FROM THE PROXIMAL END. THE BALL TIP APPEARS TO BE ABSENT. THE PROXIMAL END OF THE EMBOLIC COIL IS STRETCHED. THE ARTICULATING JOINT AND RESISTANCE HEATING (RH) COIL ARE COATED WITH A GREENISH SUBSTANCE. THE V-NOTCH OF THE RESHEATHING TOOL IS UNDAMAGED. ADVANCEMENT THROUGH A MICROCATHETER CANNOT BE ATTEMPTED BECAUSE THE EMBOLIC COIL AND DPU PROTRUDE FROM THE SKIVE OF THE TRANSLUCENT INTRODUCER SHEATH. 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 MICROCOIL SYSTEM WAS IMPEDED IN THE MICROCATHETER COULD NOT BE CONFIRMED. ADVANCEMENT OF THE EMBOLIC COIL THROUGH A MICROCATHETER COULD NOT BE TESTED BECAUSE OF DAMAGE TO THE EMBOLIC COIL. THE PRESENCE OF THE BEND IN THE DPU CORE WIRE INDICATES THAT EXCESSIVE FORCE WAS APPLIED, POSSIBLY IN AN ATTEMPT TO OVERCOME RESISTANCE. IN ADDITION, THE FACT THAT THE EMBOLIC COIL PROTRUDES FROM THE SKIVE OF THE TRANSLUCENT INTRODUCER SHEATH AND IS STRETCHED INDICATES THAT THE RESHEATHING TOOL WAS PASSED OVER THE EMBOLIC COIL WHEN THE DEVICE WAS UNSHEATHED. THE INSTRUCTIONS FOR USE (IFU) INSTRUCTS THE USER TO UNSHEATHE A SMALL LENGTH OF THE DPU TO UNLOCK THE DEVICE, THEN TO ADVANCE THE EMBOLIC COIL INTO THE MICROCATHETER UNTIL THE HUB CONNECTOR OF THE DPU REACHES THE PROXIMAL END OF THE RESHEATHING TOOL. THIS RESULTS IN THE PLACEMENT OF THE EMBOLIC COIL INSIDE THE MICROCATHETER BEFORE CONTINUING TO UNSHEATHE THE DEVICE. IF THE DEVICE IS UNSHEATHED BEFORE ADVANCING THE EMBOLIC COIL INTO THE MICROCATHETER, THERE IS A RISK THAT THE EMBOLIC COIL WILL BE UNSHEATHED AND PASS THROUGH THE RESHEATHING TOOL. THIS CAN CAUSE DAMAGE TO THE EMBOLIC COIL AND CAN ALSO CAUSE IT TO PROTRUDE FROM THE INTRODUCER. THE BALL TIP OF THE EMBOLIC COIL MAY HAVE BEEN LOST WHEN THE EMBOLIC COIL WAS DAMAGED. 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 TREATMENT OF A 3.1 X 2.2MM POSTERIOR COMMUNICATING ARTERY ANEURYSM, A DELTAPAQ COIL (CDF10031030/C35555) COULD NOT BE ADVANCED VIA THE UNSPECIFIED PROWLER 14 MICROCATHETER, AND PRODUCT ANALYSIS REVEALED THAT THE COIL WAS STRETCHED WITH THE BALL TIP ABSENT. A CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER AND THE DEVICES HAD BEEN PREPPED AND USED AS PER THE INSTRUCTIONS FOR USE. NEITHER DEVICE APPEARED DAMAGED. THEY USED ANOTHER COIL TO COMPLETE THE PROCEDURE WITHOUT LOSS OF TARGET POSITION. THERE WAS NO REPORT OF PATIENT INJURY OR PROCEDURE DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769230 DELTAPAQ - CERECYTE MICROCOIL NEUROVASCULAR EMBOLIZATION DEVICE HCG MEDOS INTERNATIONAL SARL NA C35555 00878528007210

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR