BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAPAQ - PLATINUM MICROCOIL

    MDR report key: 3111520 · Received May 14, 2013

    Report

    Report Number
    1226348-2013-20093
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    May 12, 2012
    Report Date
    December 17, 2012
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K080379
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: THIS IS AN INITIAL/FINAL REPORT. THEREFORE, NO FURTHER REPORTS WILL BE FORTHCOMING FOR THIS MEDWATCH REPORT. THE 5 MM X 10 CM DELTAPAQ PLATINUM MICROCOIL (DFS10051020/G15361) DIDN'T MOVE FORWARD THROUGH THE CATHETER. ITS USE WAS IMPEDED BECAUSE IT WAS NOT FULLY COVERED BY ITS SHEATH. THEREFORE, THE DEVICE WAS REMOVED. THE RETURNED COIL WAS FOUND STRETCHED AND SEVERED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED IN RESPONSE TO FOLLOW-UP INVESTIGATIONS. THE TIMING OF THE COIL DAMAGE AS RELATED TO PROCEDURAL USE OR POST PROCEDURAL HANDLING IS NOT KNOWN. THE 10.0CM COIL WAS RETURNED STRETCHED 130.0CM. THE COIL UNRAVELED OUT OF THE SOLDERED SECTION AND WAS SEVERED. THE FRACTURE IS DUCTILE IN NATURE REQUIRING EXTERNAL FORCE. NO MATERIAL DEFECTS WERE FOUND. THE COIL WAS FOUND PROTRUDING OUTSIDE THE SHEATH INSIDE THE RESHEATHING TOOL. NO MECHANICAL SHEATH DAMAGE RESULTING IN AN OPENED SKIVE WAS FOUND THE DEVICE POSITIONING UNIT (DPU) AND THE INTRODUCER SHEATH WERE RETURNED SEPARATED FROM EACH OTHER. DUE TO THE SEVERE DAMAGE TO THE COIL AND THE SEPARATION FROM THE INTRODUCER SHEATH, THE EVIDENCE HAS BEEN COMPROMISED. HOWEVER, THE MOST LIKELY CONTRIBUTING FACTOR TO THE COILS DIFFICULTY ADVANCING INTO THE MICROCATHETER WAS DUE TO INTERFERENCE WHETHER BY THE DPU/COIL PROTRUDING OUTSIDE THE SHEATH WHICH MAY HAVE IMPEDED ITS ADVANCEMENT OR BY DISTAL INTERFERENCE IN THE HUB TO MICROCATHETER JUNCTION OR IN THE MICROCATHETER SHAFT. ANCHORING OF THE COIL AT THE DISTAL END DURING REMOVAL IS A POSSIBLE CAUSE OF THE STRETCHED AND SEVERED COIL. HOWEVER, THE CIRCUMSTANCES AND TIMING AS RELATED TO PROCEDURAL USE/POST PROCEDURAL USE CANNOT BE DETERMINED DUE TO THE SEVERITY OF THE DAMAGE FOUND TO THE COIL. IN ADDITION WITHOUT THE IDENTIFICATION OR THE RETURN OF THE UNKNOWN MICROCATHETER AND THE ROTATING HEMOSTATIC VALVE (RHV) USED IN THE PROCEDURE, IT CANNOT BE DETERMINED IF THESE COMPONENTS CONTRIBUTED TO THE COMPLAINT EVENT. DUE TO THE RETURNED CONDITION OF THE DEVICE THE FUNCTIONAL TESTING FOR ADVANCEMENT THROUGH A CONCOMITANT CATHETER CANNOT BE PERFORMED. THE COIL WAS RETURNED SEVERELY STRETCHED AND SEVERED AND THE DPU WAS OUTSIDE OF THE INTRODUCER SHEATH WITH NO MECHANICAL SHEATH DAMAGE. THE CAUSE OF THE REPORTED EVENT AND DAMAGES TO THE COIL CANNOT BE DETERMINED. ADDITIONALLY, IT CANNOT BE CONFIRMED IF THE COIL DAMAGE, WHICH WOULD BE READILY VISIBLE TO THE END USER AND WAS NOT REPORTED, OCCURRED DURING PROCEDURAL USE OR DURING POST PROCEDURAL HANDLING. 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. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    NOTE: FINAL PRODUCT ANALYSIS FOUND STRETCHED COIL. DURING EMBOLIZATION PROCEDURE, THE COIL (DFS100510-20, LOT G15361) DID NOT ADVANCE INTO THE MICROCATHETER PRESENTING DIFFICULTIES WHEN IT WAS NOT COVERED BY THE SHEATH IMPEDING ITS USE. FOR THIS REASON, IT WAS REMOVED. NO ADDITONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213051 DELTAPAQ - PLATINUM MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA G15361

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN MICROCATHETER