BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM

    MDR report key: 3902712 · Received June 30, 2014

    Report

    Report Number
    1226348-2014-30033
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 6, 2014
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    HCG
    PMA / PMN Number
    K120686
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT REMAINS IMPLANTED, AND WILL NOT BE RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. 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.

    Additional Manufacturer Narrative · 1

    IT WAS STATED THAT THERE WAS A SIGNIFICANT DELAY TO THE PROCEDURE DUE TO THE ISSUE; HOWEVER, THE LENGTH OF THE DELAY IS UNKNOWN. IT WAS REPORTED THAT THERE WAS NO PATIENT INJURY AS A RESULT OF THE DELAY. THE ENPOWER BOX (DCB00000500/F55871) HAD BEEN USED LESS THAN 50 TIMES IN 4 YEARS, AND THE PROCEDURE WAS COMPLETED WITH THE SAME ENPOWER BOX. CONCLUSION: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. 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. WITHOUT RETURN OF THE COILS FOR ANALYSIS, THE COIL DETACHMENT DIFFICULTY AND COIL SEPARATION RESULTING IN PROTRUSION INTO THE PARENT VESSEL COULD NOT BE CONFIRMED, AND THE ROOT CAUSE OF THE REPORTED FAILURES COULD NOT BE DETERMINED. THE RETURNED DCB AND CABLE FUNCTIONED AS EXPECTED DURING ANALYSIS; THEREFORE, THE DETACHMENT DIFFICULTY WAS MOST LIKELY NOT RELATED TO THOSE DEVICES. THERE ARE PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THE COIL SEPARATION. IT IS POSSIBLE THAT INTERACTION WITH OTHER DEVICES RESULTING IN ANCHORING OF THE COIL DURING RETRACTION MAY HAVE CONTRIBUTED. THE INSTRUCTIONS FOR USE (IFU) CAUTIONS THAT IF THE MICROCOIL SYSTEM BECOMES IMMOBILE IN THE INFUSION MICROCATHETER, APPLY A GENTLE PUSH-PULL MOTION TO FREE IT. IF UNSUCCESSFUL, REMOVE BOTH MICROCATHETER AND MICROCOIL SYSTEM TOGETHER AS A UNIT AND REPLACE WITH NEW DEVICES. IT IS FURTHER CAUTIONED THAT 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. BASED ON THE AVAILABLE INFORMATION, THE DHR REVIEWS AND THE ANALYSIS OF THE PRODUCTS RETURNED, THERE WAS NO EVIDENCE OF A MANUFACTURING ISSUE BEING RELATED TO THE COIL DETACHMENT DIFFICULTY AND SEPARATION; THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    THE PHYSICIAN COULD NOT DETACH THE ORBIT GALAXY G2 4MM X 6CM COIL (641CX0406/C12873) AND HAD TROUBLE DETACHING ANOTHER ORBIT GALAXY G2 COIL (DETAILS UNKNOWN) DURING AN OPERATION. SHE TRIED 5 TIMES TO DETACH EACH COIL. FIRST, SHE TRIED TO WITHDRAW AND ADVANCE THE COIL (641CX0406/C12873) EXPECTING THAT IT WOULD BE DETACHED. THEN SHE CHANGED THE CONNECTING CABLE (CCB00015700/LOT UNKNOWN), WHICH WAS PREVIOUSLY USED TO ANOTHER ONE (CCB00015700/LOT UNKNOWN), WHICH WAS ALSO PREVIOUSLY USED. AFTER THAT, SHE CHANGED THE CONNECTING CABLE AGAIN TO A BRAND NEW ONE (CCB00015700/LOT UNKNOWN) AND THE COIL STILL DID NOT DETACH. FINALLY, SHE DECIDED TO REDEPLOY COIL, BUT THE COIL WAS TORN. 5 CENTIMETERS OF THE LENGTH OF THE COIL WAS EITHER IN OR HUNG OUT OF AN ANEURYSM, AND THE OTHER 1 CENTIMETER STUCK WITH THE DELIVERY SYSTEM. SHE HAD TO PUSH THE HANGING COIL INTO ANEURYSM BY USING THE DELIVERY SYSTEM SHAFT. SHE THEN USED A SECOND ORBIT GALAXY G2 COIL (DETAILS UNKNOWN) AND IT WAS STILL DIFFICULT TO DETACH. SHE SAID THAT THE COIL MIGHT HAVE BEEN PARTIALLY DETACHED AND THERE MAY HAVE BEEN SOMETHING WRONG WITH THE ENPOWER DETACHMENT CONTROL BOX (DCB00000500/LOT UNKNOWN) BECAUSE IT TOOK MORE THAN 3 SECONDS TO DETACH AND BECAUSE THE SECOND G2 COIL STILL TOOK MANY TIMES TO DETACH. THIS ENPOWER BOX (DETAILS UNKNOWN) WAS USED LESS THAN 50 TIMES IN 4 YEARS.

    Description of Event or Problem · 1

    THE PHYSICIAN COULD NOT DETACH THE ORBIT GALAXY G2 4MM X 6CM COIL (641CX0406/C12873) AND HAD TROUBLE DETACHING ANOTHER ORBIT GALAXY G2 COIL (641CX0304/C15533) DURING COIL EMBOLIZATION OF AN ANTERIOR COMMUNICATION ARTERY ANEURYSM. SHE TRIED 5 TIMES TO DETACH EACH COIL. FIRST, SHE ATTEMPTED TO WITHDRAW AND ADVANCE THE COIL (641CX0406/C12873) EXPECTING THAT IT WOULD BE DETACHED. THERE WERE THREE CONNECTING CABLES USED IN THIS PROCEDURE, INCLUDING TWO STANDARD CONNECTING CABLES (CCB00015700/M10602 AND CCB00015700/LOT UNKNOWN) AND AN ENPOWER CONNECTING CABLE (ECB000182-00/LOT UNKNOWN). THE ORDER THE CONNECTING CABLES WERE USED WAS UNCLEAR. AFTER TRYING TO ADVANCE AND WITHDRAW THE COIL IN AN ATTEMPT TO DETACH THE COIL, SHE CHANGED THE FIRST CONNECTING CABLE, WHICH WAS PREVIOUSLY USED TO ANOTHER ONE, WHICH WAS ALSO PREVIOUSLY USED. AFTER THAT, SHE CHANGED THE CONNECTING CABLE AGAIN TO A BRAND NEW ONE AND THE COIL STILL DID NOT DETACH. FINALLY, SHE DECIDED TO REDEPLOY COIL, BUT THE COIL BECAME SEPARATED WITH 5 CM OF THE LENGTH OF THE COIL WITHIN OR HUNG OUT OF THE ANEURYSM, AND THE OTHER 1 CM STUCK WITHIN THE DELIVERY SYSTEM. SHE HAD TO PUSH THE HANGING COIL BACK INTO ANEURYSM BY USING THE DELIVERY SYSTEM SHAFT. SHE THEN USED A SECOND ORBIT GALAXY G2 COIL (641CX0304/C15533) AND IT WAS STILL DIFFICULT TO DETACH. SHE FELT THAT THERE MAY HAVE BEEN SOMETHING WRONG WITH THE ENPOWER DETACHMENT CONTROL BOX (DCB00000500/F55871) BECAUSE IT TOOK MORE THAN 3 SECONDS TO DETACH THE COIL. A PRE-DEPLOYMENT ELECTRICAL CHECK HAD BEEN PERFORMED AND THERE WAS NO LOW BATTERY OR FAULT LIGHT SEEN. UPON PRESSING THE POWER BUTTON, ALL LIGHTS ILLUMINATED. THE GREEN SYSTEM READY LIGHT ILLUMINATED AND DURING THE DETACHMENT CYCLE, THE DETACHMENT LIGHT ILLUMINATED. THE AUDIBLE SIGNAL DID NOT BEEP. ALL CONNECTIONS APPEARED TO FIT PROPERLY WITHOUT APPLICATION OF EXCESSIVE FORCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379023 ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM ARTIFICIAL EMBOLIZATION DEVICE HCG CODMAN AND SHURTLEFF, INC C12873

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention