BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM

    MDR report key: 6057629 · Received October 26, 2016

    Report

    Report Number
    2954740-2016-00257
    Event Type
    Malfunction
    Date Received
    October 26, 2016
    Date of Event
    June 24, 2016
    Report Date
    October 4, 2016
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    HCG
    UDI-DI
    10878528008924
    PMA / PMN Number
    K120686
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED FOR ANALYSIS; HOWEVER, THE ANALYSIS HAS NOT BEEN COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    CONCLUSION: AS REPORTED BY A HEALTHCARE PROFESSIONAL, A G2 COMPLEX XTRASOFT COIL (641CX0304/C25122) DID NOT FIT IN THE INTERNAL CAROTID ARTERY ANEURYSM AT THE FIRST PUSH, AND WHEN PULLING THE COIL INTO THE SL10 MICROCATHETER, THE COIL STRETCHED. THE COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM WHEN REMOVED. A CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE EXCELSIOR SL 10, 0.0165¿ MICROCATHETER AND THERE WAS NO RESISTANCE BETWEEN THE MICROCATHETER AND COIL. THE MICROCATHETER DID NOT APPEAR DAMAGED. NO ADDITIONAL INTERVENTION WAS REQUIRED. UNFORTUNATELY THE PHYSICIAN HAD LEFT THE HOSPITAL WHERE THE EVENT OCCURRED. FOR THIS REASON, IT WAS DIFFICULT TO GATHER FURTHER INFORMATION. IT WAS UNKNOWN IF THE EVENT RESULTED IN PATIENT INJURY OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. IT WAS ALSO UNKNOWN IF THE MICROCATHETER HAD BEEN REPOSITIONED OVER THE COIL WHILE THE COIL WAS DEPLOYED OR PARTIALLY DEPLOYED OUT OF THE DISTAL END OF THE MICROCATHETER, OR IF A ONE TO ONE RELATIONSHIP BETWEEN THE COIL AND DELIVERY TUBE WAS VERIFIED WITH FLUORO PRIOR TO REPOSITIONING. IT WAS ALSO UNKNOWN IF COIL ENTANGLEMENT WAS SUSPECTED TO CONTRIBUTE TO THE EVENT. IT WAS REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS. THE DEVICE WAS RETURNED FOR ANALYSIS. THE SL-10 MICROCATHETER AND THE ROTATING HEMOSTATIC VALVE (RHV) WERE 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. AS VIEWED INTO THE RETURNED PACKAGING, UNREPORTED SEVERING OF THE COIL WAS FOUND. A PORTION OF THE STRETCHED COIL WAS FOUND IN BETWEEN THE MELTED PORTION OF THE BUBBLE WRAP USED TO RETURN THE PRODUCT. IT HAS BEEN PREVIOUSLY REPORTED THAT IT IS NOT CORRECT TO PLACE THE RETURNED DEVICE INSIDE BUBBLE WRAP AND MELT THE PLASTIC TOGETHER AS IN THIS CASE WHICH MAY HAVE PRODUCED FURTHER DAMAGE BY SEVERING THE COIL, THEREFORE DUE TO PRODUCT MISHANDLING FOR RETURN SHIPMENT, ADDITIONAL PRODUCT DAMAGE MAY HAVE OCCURRED AFTER THE PROCEDURE WHICH MAY HAVE SEVERED THE COIL AND PRODUCED FURTHER COIL STRETCHING. THE REMAINDER OF THE SEVERED AND STRETCHED COIL WAS FOUND TO HAVE BEEN ENTANGLED IN THE DEVICE POSITIONING UNIT (DPU) AND THE SHEATH. THE PROXIMAL STRETCHED SECTION OF THE COIL WAS SEVERED BY EXTERNAL FORCE VIA DUCTILE FRACTURE AS NO MATERIAL DEFECTS WERE FOUND. NO MANUFACTURING DEFECTS WERE FOUND. 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 COIL STRETCHING WAS CONFIRMED. DUE TO THE NON-RETURN OF THE SL-10 MICROCATHETER, THE MISHANDLING OF THE COIL AFTER THE PROCEDURE WHICH CAUSED FURTHER COIL DAMAGE AND THE UNREPORTED COIL SEVERING TO OCCUR, AND WITHOUT FURTHER EVIDENCE, THE ROOT CAUSE OF HOW AND WHEN THE COIL WAS STRETCHED CANNOT BE DETERMINED. HOWEVER, IT IS HIGHLY POSSIBLE, SINCE IT WAS STATED THE COIL STRETCHED DURING PULL BACK INTO THE MICROCATHETER, THE COIL MAY HAVE BECOME TEMPORARILY ENTANGLED ON THE COILS ALREADY DWELLING INSIDE THE ANEURYSM (IF PREVIOUSLY PLACED), ON ITSELF, OR ON THE DISTAL TIP OF THE MICROCATHETER. IF THIS OCCURRED THEN FOR OPTIMUM PRODUCT PERFORMANCE AND TO PREVENT POTENTIAL COMPLICATIONS, THE INSTRUCTIONS FOR USE (IFU) RECOMMENDS, ¿CAUTION: 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. CAUTION: 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.¿ IN ADDITION WITHOUT THE RETURN OF THE SL-10 MICROCATHETER AND THE RHV USED IN THE PROCEDURE, IT CANNOT BE DETERMINED IF THESE COMPONENTS CONTRIBUTED TO THE COMPLAINT EVENT. POSSIBLE CONTRIBUTING FACTORS TO THE COILS POSITIONING DIFFICULTY MAY HAVE BEEN THE PATIENT¿S ANATOMY, THE COILS ALREADY DWELLING INSIDE THE TARGET SITE (IF PREVIOUSLY PLACED) OR ENCOUNTERED INTERFERENCE ON ITSELF DURING ADVANCEMENT INTO THE TARGET SITE. SINCE THERE WAS NO EVIDENCE THAT THE COIL DAMAGE OR POSITIONING DIFFICULTY WERE RELATED TO A MANUFACTURING ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED BY A HEALTHCARE PROFESSIONAL, A G2 COMPLEX XTRASOFT COIL (641CX0304/C25122) DID NOT FIT IN THE INTERNAL CAROTID ARTERY ANEURYSM AT THE FIRST PUSH, AND WHEN PULLING THE COIL INTO THE SL10 MICROCATHETER, THE COIL STRETCHED. THE COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM WHEN REMOVED. A CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE EXCELSIOR SL 10, 0.0165" MICROCATHETER AND THERE WAS NO RESISTANCE BETWEEN THE MICROCATHETER AND COIL. THE MICROCATHETER DID NOT APPEAR DAMAGED. NO ADDITIONAL INTERVENTION WAS REQUIRED. UNFORTUNATELY, THE PHYSICIAN HAD LEFT THE HOSPITAL WHERE THE EVENT OCCURRED. FOR THIS REASON, IT WAS DIFFICULT TO GATHER FURTHER INFORMATION. IT WAS UNKNOWN IF THE EVENT RESULTED IN PATIENT INJURY OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. IT WAS ALSO UNKNOWN IF THE MICROCATHETER HAD BEEN REPOSITIONED OVER THE COIL WHILE THE COIL WAS DEPLOYED OR PARTIALLY DEPLOYED OUT OF THE DISTAL END OF THE MICROCATHETER, OR IF A ONE TO ONE RELATIONSHIP BETWEEN THE COIL AND DELIVERY TUBE WAS VERIFIED WITH FLUORO PRIOR TO REPOSITIONING. IT WAS ALSO UNKNOWN IF COIL ENTANGLEMENT WAS SUSPECTED TO CONTRIBUTE TO THE EVENT. IT WAS REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707979 ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM NEUROVASCULAR EMBOLIZATION DEVICE HCG MEDOS INTERNATIONAL SARL NA C25122 10878528008924

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR EXCELSIOR SL 10, 0.0165¿ MICROCATHETER