BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAPLUSH - PLATINUM MICROCOIL

    MDR report key: 5257770 · Received December 1, 2015

    Report

    Report Number
    2954740-2015-00270
    Event Type
    Malfunction
    Date Received
    December 1, 2015
    Date of Event
    November 5, 2015
    Report Date
    November 9, 2015
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    HCG
    PMA / PMN Number
    K083646
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. AS VIEWED THROUGH THE RETURNED PACKAGING, IT WAS FOUND THAT THE COIL WAS RETURNED UNSHEATHED AND UNPROTECTED. LOCATED 132.0 CENTIMETERS OFF THE PROXIMAL END IS A KINK ON THE DEVICE POSITIONING UNIT¿S (DPU) CORE WIRE. THE COIL WAS RETURNED UNDAMAGED. THE DETACHMENT FIBER IS UNDAMAGED, INTACT, AND DID NOT RECEIVE HEAT AND MELT. THE DEVICE POSITIONING UNIT (DPU) PASSED ELECTRICAL TESTING WITH RESISTANCE AT 54.1 OHMS (RANGE 48.5/56.0) AND THE ENPOWER AND CABLE SYSTEM¿S READY GREEN LIGHT ILLUMINATED (IFU). THE COIL DETACHED ON THE FIRST DETACHMENT CYCLE. POST-DETACHMENT INSPECTION FOUND THAT THE ENPOWER SYSTEM¿S READY GREEN LIGHT REMAINED ILLUMINATED AND THE RESISTANCE PASSED AT 54.1 OHMS. POST-DETACHMENT INSPECTION FOUND THAT THE DETACHMENT FIBER RECEIVED HEAT AND MELTED AS DESIGNED. THE FIELD COMPLAINT OF THE COIL¿S NON-DETACHMENT COULD NOT BE DUPLICATED. NO MANUFACTURING DEFECTS WERE FOUND. DHR: A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (P10047) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE COMPLAINT OF THE COILS NON-DETACHMENT IS NOT CONFIRMED. THE DPU PASSED ELECTRICAL TESTING AND DETACHED THE COIL ON THE FIRST DETACHMENT CYCLE; THEREFORE THE ROOT CAUSE OF THE COILS NON-DETACHMENT CANNOT BE DETERMINED. IN ADDITION, WITHOUT THE RETURN OF THE COMPLETE DETACHMENT SYSTEM AND THE IDENTIFICATION OR THE RETURN OF THE UNKNOWN MICROCATHETER USED IN THE PROCEDURE, IT CANNOT BE DETERMINED IF THESE COMPONENTS CONTRIBUTED TO THE COMPLAINT EVENT. THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS, HOWEVER IT HAS NOT BEEN RECEIVED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. NO CONCLUSIONS ARE MADE AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    THE CONTACT FROM THE FACILITY REPORTED THAT THE DELTAPLUSH (DPL10040820/(B)(4)) COIL COULD NOT DETACH. ANOTHER LIKE DEVICE HAS BEEN USED TO PERFORM THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789612 DELTAPLUSH - PLATINUM MICROCOIL CNV DCS COILS HCG MEDOS INTERNATIONAL SARL P10047

    Patients

    Seq Age Sex Outcome Treatment
    1