BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESIDIO 10 - CERECYTE MICROCOIL

    MDR report key: 6025451 · Received October 13, 2016

    Report

    Report Number
    2954740-2016-00237
    Event Type
    Malfunction
    Date Received
    October 13, 2016
    Date of Event
    September 20, 2016
    Report Date
    September 23, 2016
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    HCG
    UDI-DI
    00878528003007
    PMA / PMN Number
    K082739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS FINAL MDR BEING REPORTED FOR THIS COMPLAINT WITH ASSOCIATED MFR# 2954740-2016-00237. ADDITIONAL INFORMATION RECEIVED ON 20 OCT 2016. THE COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM WHEN REMOVED FROM THE PATIENT AND NO STRETCHING WAS NOTED ON THE COIL UPON REMOVAL. THE LOW BATTERY LIGHT WAS NOT SEEN DURING THE CASE AND THE GREEN SYSTEM READY LIGHT ILLUMINATED. IT IS UNKNOWN IF THE DETACHMENT LIGHT ILLUMINATED DURING THE DETACHMENT CYCLE OR THE AUDIBLE SIGNAL BEEPED WHEN AN ATTEMPT TO DETACH THE COIL WAS MADE. ALL CONNECTIONS APPEARED TO FIT PROPERLY WITHOUT APPLICATION OF EXCESSIVE FORCE. THE SAME CONNECTING CABLE AND DCB (ENPOWER CABLE AND DCB, LOT UNKNOWN) WERE USED SUCCESSFULLY WITH SUBSEQUENT COILS. THERE WERE NO INTRA OR POST PROCEDURAL COMPLICATIONS OR DELAY RELATED TO DEVICE OR REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF ONE INITIAL/FINAL MDR BEING SUBMITTED FOR THIS COMPLAINT WITH ASSOCIATED MFR# 2954740-2016-00237. (B)(4). VERY LIMITED INFORMATION WAS RECEIVED. THE UNIDENTIFIED DETACHMENT CONTROL BOX (DCB) AND CONNECTING CABLE WERE NOT RETURNED. THE UNIDENTIFIED MICROCATHETER WAS NOT RETURNED. CONCERNING CLEANLINESS ONLY, THE MICROCOIL SYSTEM WAS RETURNED IN ALMOST PRISTINE CONDITION. THE SYSTEM WAS EITHER NOT USED OR WAS CLEANED BEFORE BEING RETURNED WHICH MAY HAVE PRODUCED FURTHER DAMAGE. IT IS ALSO UNKNOWN IF THE DEVICE WAS IMPROPERLY HANDLED FOR RETURNED PACKAGING OR WAS FURTHER MANIPULATED AND/OR INSPECTED POST-PROCEDURALLY. IN ADDITION, ANY TRACE OR OTHER EVIDENCE THAT MAY HAVE BEEN COMPLAINT RELATED MAY HAVE BEEN ALTERED OR REMOVED PRIOR TO BEING RETURNED DUE TO POST-PROCEDURAL HANDLING, CLEANING, AND PACKAGING. ALL LOCATION AND MEASUREMENT CALLOUTS ARE APPROXIMATE AND FOR REFERENCE ONLY. UNREPORTED DAMAGE OF THE COIL BEING RETURNED STRETCHED WHICH CAUSED THE COIL TO LOSE ITS FRAMING SHAPE WAS FOUND. THE CIRCUMSTANCES OF HOW AND WHEN THIS UNREPORTED COIL DAMAGE OCCURRED CANNOT BE DETERMINED. THE COIL WAS PUSHED DOWN INSIDE THE OUTER SHEATH AND AGAINST THE RESISTIVE HEATING COIL. THE DETACHMENT FIBER DID NOT RECEIVE HEAT AND MELT. DEVICE POSITIONING UNIT (DPU) FAILED ELECTRICAL TESTING WITH RESISTANCE AT 31.3 OHMS (RANGE 48.5/56.0) AND THE TEST ENPOWER AND CABLE SYSTEMS READY GREEN LIGHT FAILED TO ILLUMINATE (PRESIDIO IFU). NO MANUFACTURING DEFECTS WERE FOUND. THE COMPLAINT OF THE COILS NON-DETACHMENT IS CONFIRMED. WHILE THE ROOT CAUSE OF THE COILS NON-DETACHMENT CANNOT BE DETERMINED, THE EVIDENCE AS RECEIVED HIGHLY SUGGESTS THE MOST LIKELY CONTRIBUTING FACTOR TO THE COILS NON-DETACHMENT MAY HAVE BEEN DUE TO A FRACTURE OF THE SOLDER JOINT CONNECTION INSIDE THE RESISTIVE HEATING COIL OR FROM WIRING DAMAGE. IT CANNOT BE DETERMINED IF THE DAMAGE FOUND TO THE UNIT INFLUENCED THE COMPLAINT EVENT WHEN THE COIL WAS DAMAGED AND THE COIL¿S SOCKET RING WAS PUSHED DOWN INSIDE THE OUTER SHEATH AND AGAINST THE RESISTIVE HEATING COIL WHERE THE SUSPECTED DAMAGE OCCURRED. THE CIRCUMSTANCES OF HOW AND WHEN THE WIRING DAMAGE OCCURRED CANNOT BE DETERMINED AS ALL MICROCOIL SYSTEMS ARE TESTED PRIOR TO FINAL PACKAGING. IN ADDITION, WITHOUT THE IDENTIFICATION OR THE RETURN OF THE COMPLETE DETACHMENT SYSTEM AND THE MICROCATHETER USED IN THE PROCEDURE, IT CANNOT BE DETERMINED IF THESE COMPONENTS CONTRIBUTED TO THE COMPLAINT EVENT. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. BASED ON THE INFORMATION AND THE ANALYSIS, THE EVENT WAS CONFIRMED. WHILE THE ROOT CAUSE OF THE COILS NON-DETACHMENT CANNOT BE DETERMINED, THE MOST LIKELY CONTRIBUTING FACTOR TO THE FAILURE MAY HAVE BEEN DUE TO A FRACTURE OF THE SOLDER JOINT CONNECTION INSIDE THE RESISTIVE HEATING COIL OR FROM WIRING DAMAGE. WITHOUT RETURN OF CONCOMITANT PRODUCTS IT CANNOT BE DETERMINED IF THOSE COMPONENTS HAD ANY ADDITIONAL CONTRIBUTIONS TO THE COMPLAINT EVENT. ADDITIONALLY, REVIEW OF THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION THE PRESIDIO COIL (PC410041230/C23787) COULD NOT BE DETACHED. THE COIL WAS WITHDRAWN AND USED A NEW COIL (LOT UNKNOWN) TO COMPLETE THE PROCEDURE. PROCEDURE DETAILS AND PATIENT INFORMATION ARE UNKNOWN. IT WAS INITIALLY REPORTED THAT THE COMPLAINT DEVICE IS AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676665 PRESIDIO 10 - CERECYTE MICROCOIL NEUROVASCULAR EMBOLIZATION DEVICE HCG MEDOS INTERNATIONAL SARL NA C23787 00878528003007

    Patients

    Seq Age Sex Outcome Treatment
    1