BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XTRASOFT ORBIT GALAXY DETACHABLE COIL

    MDR report key: 3931258 · Received July 14, 2014

    Report

    Report Number
    1226348-2014-30044
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 19, 2014
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    HCG
    PMA / PMN Number
    K093973
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). COMPLAINT CONCLUSION: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. REVIEW OF DHR FOR LOT 15912164 CONCLUDED THAT THERE WERE NO ISSUES WERE THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. THE COIL STRETCHING OF THE ORBIT GALAXY COULD NOT BE CONFIRMED WITHOUT PRODUCT RETURN FOR ANALYSIS. ALTHOUGH THE ROOT CAUSE OF THE CUSTOMER COIL STRETCHING COULD NOT BE CONFIRMED, PROCEDURAL/HANDLING FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. PER THE INSTRUCTIONS FOR USE, ¿IF THE MICROCOIL IS POSITIONED AT A RELATIVE SHARP ANGLE TO THE MICROCATHETER, A MICROCOIL MAY STRETCH OR BREAK AS IT IS BEING WITHDRAWN. BY REPOSITIONING THE DISTAL TIP OF THE CATHETER AT OR SLIGHTLY INSIDE THE OSTIUM OF THE ANEURYSM, THE MICROCOIL MAY BE MORE EASILY FUNNELED BACK INTO THE MICROCATHETER. IF REPOSITIONING OF THE MICROCOIL IS NECESSARY, CAREFULLY OBSERVE THE MOTION OF THE MICROCOIL IN RESPECT TO THE DPU WIRE WHILE RETRACTING THE MICROCOIL UNDER FLUOROSCOPY. IF THE MICROCOIL MOVEMENT IS NOT ONE-TO-ONE WITH THE DPU WIRE, OR IF REPOSITIONING IS DIFFICULT, THE MICROCOIL MAY HAVE BECOME STRETCHED AND COULD POSSIBLY BREAK. GENTLY REMOVE AND DISCARD THE MICROCOIL SYSTEM.¿ THERE IS NO EVIDENCE THAT THERE WERE ANY MANUFACTURING ISSUES RELATED TO THE COMPLAINT; THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS AN INITIAL/FINAL MDR.

    Description of Event or Problem · 1

    DURING COIL EMBOLIZATION OF AN ANEURYSM IN THE LEFT INTERNAL CAROTID ARTERY, A MICRUSPHERE 10 CERECYTE COIL (CSP10025030/C20767) WAS UNABLE TO BE ADVANCED IN THE SL-10 MICROCATHETER AND AN ORBIT GALAXY COMPLEX XTRASOFT COIL (640CX2535/15912164) STRETCHED DURING INSERTION INTO THE TARGET ANEURYSM. IT WAS REPORTED THAT A CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER. THE MICRUSPHERE WAS REMOVED FROM THE MICROCATHETER WITH NO REPORT OF COIL OR MICROCATHETER DAMAGE. THE ORBIT GALAXY STRETCHED WHEN THE COIL WAS PARTLY IN THE MICROCATHETER AND PARTLY IN THE ANEURYSM. IT WAS REPORTED THAT THE MICROCATHETER HAD NOT BEEN REPOSITIONED OVER THE COIL WHILE THE COIL WAS DEPLOYED OR PARTIALLY DEPLOYED OUT OF THE DISTAL END OF THE MICROCATHETER; HOWEVER A ONE TO ONE RELATIONSHIP BETWEEN THE COIL AND DELIVERY TUBE WAS NOT VERIFIED WITH FLUORO PRIOR TO REPOSITIONING. IT WAS UNKNOWN IF THE COIL MAY HAVE BEEN ENTANGLED WITH PREVIOUSLY PLACED COILS OR IF THE MICROCOIL WAS POSITIONED AT A RELATIVE SHARP ANGLE TO THE MICROCATHETER. THE ENTIRE COIL WAS REMOVED AND THE SAME MICROCATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410862 XTRASOFT ORBIT GALAXY DETACHABLE COIL ARTIFICIAL EMBOLIZATION DEVICE HCG CODMAN AND SHURTLEFF, INC NA 15912164

    Patients

    Seq Age Sex Outcome Treatment
    1