BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESIDIO 10 - CERECYTE MICROCOIL

    MDR report key: 5710826 · Received June 9, 2016

    Report

    Report Number
    1226348-2016-00104
    Event Type
    Malfunction
    Date Received
    June 9, 2016
    Date of Event
    May 16, 2016
    Report Date
    May 20, 2016
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    HCG
    PMA / PMN Number
    K082739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS FOLLOW-UP CORRECTION MDR REPORT BEING SUBMITTED FOR THIS COMPLAINT. (B)(4). PMA/510 K (#) CHANGED FROM K082739 TO K002056.

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF ONE FINAL REPORT BEING SUBMITTED FOR THIS COMPLAINT. VERY LIMITED INFORMATION WAS RECEIVED. BOTH THE UNIDENTIFIED ENPOWER DETACHMENT CONTROL BOX (DCB) AND THE UNKNOWN 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/RINSED 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. THE DETACHMENT FIBER WAS RETURNED UNDAMAGED, INTACT, AND DID NOT RECEIVE HEAT AND MELT. THE DEVICE POSITIONING UNIT (DPU) FAILED ELECTRICAL TESTING WITH RESISTANCE AT 0.0 OHMS (RANGE 48.5/56.0) AND THE TEST ENPOWER AND TEST CABLE SYSTEMS READY GREEN LIGHT FAILED TO ILLUMINATE (IFU). MANIPULATION OF THE DISTAL TIP OF THE RESISTIVE HEATING COIL SECTION BROUGHT THE RESISTANCE INTO A STILL FAILING READOUT OF AN UPWARD READOUT OF >24.15 MEGA OHMS. THE COMPLAINT OF THE COILS NON-DETACHMENT IS CONFIRMED. THE DPU FAILED ELECTRICAL TESTING. WHILE THE EXACT ROOT CAUSE CANNOT BE DETERMINED, THE MOST LIKELY CONTRIBUTING FACTOR MAY HAVE BEEN DUE TO A FRACTURE OF THE SOLDER JOINT CONNECTION IN THE DISTAL END OF THE RESISTIVE HEATING COIL SECTION. THE CIRCUMSTANCES OF HOW AND WHERE THIS DAMAGE OCCURRED CANNOT BE DETERMINED AS ALL MICROCOIL SYSTEMS ARE ELECTRICALLY TESTED PRIOR TO FINAL PACKAGING. IN ADDITION, WITHOUT THE IDENTIFICATION OR THE RETURN OF THE ENPOWER DCB, THE CONNECTING CABLE, AND THE UNKNOWN MICROCATHETER USED IN THE PROCEDURE, IT CANNOT BE DETERMINED IF THESE COMPONENTS HAD ANY ADDITIONAL CONTRIBUTIONS 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. THE REPORTED COMPLAINT OF THE PRESIDIO COIL (PC410041230/C26881) FAILING TO DETACH WAS CONFIRMED. THE EXACT ROOT CAUSE CANNOT BE DETERMINED; HOWEVER THE MOST LIKELY CONTRIBUTING FACTOR MAY HAVE BEEN DUE TO A FRACTURE OF THE SOLDER JOINT CONNECTION IN THE DISTAL END OF THE RESISTIVE HEATING COIL SECTION. SINCE THERE WAS NO EVIDENCE OF A MANUFACTURING ISSUE RELATED TO THE EVENT, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RECEIVED FOR ANALYSIS, BUT IT HAS NOT BEEN COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. (B)(4). CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: ANOTHER COIL (DETAILS UNKNOWN), CONNECTING CABLE (DETAILS UNKNOWN), DETACHMENT CONTROL BOX (DETAILS UNKNOWN).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE HOSPITAL CONTACT THAT DURING THE COIL EMBOLIZATION, THE COIL (PC410041230/C26881) COULD NOT BE DETACHED. WITHDREW THE COIL AND USED ANOTHER COIL (DETAILS UNKNOWN) TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT ON THE PATIENT INJURY. THE PATIENT IS MALE AND (B)(6) YEARS OLD, HAS ACOM WITH A SIZE OF 4.23*4.15MM, NECK WIDTH 2.33MM. IT WAS INITIALLY REPORTED THAT THE PRODUCT WILL BE RETURNED FOR ANALYSIS. THERE WERE NO DAMAGES NOTED ON THE PRODUCT. A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED. THE LOW BATTERY LIGHT WAS NOT SEEN DURING THE CASE. IT IS UNKNOWN IF THE FAULT LIGHT WAS SEEN DURING THE CASE. THE GREEN SYSTEM READY LIGHT ILLUMINATED. IT IS UNKNOWN IF THE DETACHMENT LIGHT ILLUMINATED DURING THE DETACHMENT CYCLE. IT IS UNKNOWN IF THE AUDIBLE SIGNAL BEEPED. ALL CONNECTIONS APPEARED TO FIT PROPERLY WITHOUT APPLICATION OF EXCESSIVE FORCE. THE SAME CONNECTING CABLE (DETAILS UNKNOWN) AND DETACHMENT CONTROL BOX (DETAILS UNKNOWN) WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366581 PRESIDIO 10 - CERECYTE MICROCOIL CNV DCS COILS HCG MEDOS INTERNATIONAL SARL C26881

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR