BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM

    MDR report key: 4801949 · Received May 28, 2015

    Report

    Report Number
    2954740-2015-00117
    Event Type
    Malfunction
    Date Received
    May 28, 2015
    Date of Event
    April 22, 2015
    Report Date
    June 3, 2015
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    HCG
    PMA / PMN Number
    K120686
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR ANALYSIS; HOWEVER, THE ANALYSIS HAS NOT YET BEEN COMPLETED. INFORMATION REGARDING PATIENT AGE, GENDER, WEIGHT, AND CONCOMITANT MEDICATIONS AND DEVICES WAS NOT AVAILABLE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: DURING COIL EMBOLIZATION OF AN ANTERIOR COMMUNICATING ARTERY ANEURYSM, A GALAXY G2 ((B)(4)) FAILED TO DETACH. THE COIL WAS ALMOST THE LAST COIL TO BE PLACED IN THE ANEURYSM. UPON ATTEMPTING TO DETACH THE COIL, NO SIGNAL WAS SEEN ON THE DETACHMENT BOX USED. THE DETACHMENT CABLE WAS EXCHANGED AND AGAIN THERE WAS NO SIGNAL DURING ATTEMPTED DETACHMENT. THEREFORE, THE PHYSICIAN RECAPTURED THE COIL AND USED ANOTHER COIL TO CONTINUE THE PROCEDURE. PRIOR TO LOADING THE NEW COIL INTO THE MICROCATHETER, HE CONNECTED THE PROXIMAL DETACHMENT PART OF THE COIL DELIVERY WIRE TO THE CONNECTING CABLE TO CONFIRM THAT THE DEVICE WAS WORKING, AND THERE WERE WAS A SIGNAL ON THE DETACHMENT BOX. THE SAME CABLE AND DETACHMENT CONTROL BOX USED WITH THE COMPLAINT PRODUCT WAS USED TO COMPLETE THE PROCEDURE. THE EVENT RESULTED IN A 5 MINUTE DELAY IN THE PROCEDURE, BUT NO PATIENT ADVERSE EVENT. THE PROCEDURE WAS CONTINUED WITH A SIMILAR PRODUCT. IT WAS REPORTED THAT A PRE-DEPLOYMENT ELECTRICAL CHECK HAD NOT BEEN PERFORMED. THE ACTUAL COIL DID NOT APPEAR DAMAGED. THE DEVICE HAD BEEN STORED AS PER THE LABELING INSTRUCTIONS. THE GALAXY G2 WAS RETURNED FOR ANALYSIS, BUT THE DETACHMENT CONTROL BOX, CONNECTING CABLE, AND MICROCATHETER WERE NOT RETURNED. 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 FURTHER MANIPULATED AND/OR INSPECTED POST-PROCEDURALLY. ANY TRACE EVIDENCE THAT MAY HAVE BEEN COMPLAINT RELATED MAY HAVE BEEN ALTERED OR REMOVED PRIOR TO BEING RETURNED. AS VIEWED THROUGH THE RETURNED PACKAGING, THE COIL WAS FOUND TO BE EXPOSED AND UNPROTECTED. THE COIL WAS RETURNED UNDAMAGED. THE DETACHMENT FIBER DID NOT RECEIVE HEAT AND MELT. NO MANUFACTURING DEFECTS WERE FOUND. THE DEVICE POSITIONING UNIT (DPU) FAILED ELECTRICAL TESTING WITH RESISTANCE FAILING AT 79.5 OHMS AND THE ENPOWER SYSTEMS GO GREEN LIGHT FAILED TO ILLUMINATE. MANIPULATION OF THE RESISTIVE HEATING COIL SECTION MADE THE DPU PASS ELECTRICAL TESTING WITH RESISTANCE PASSING AT 57.3 OHMS AND THE ENPOWER SYSTEMS GO GREEN LIGHT ILLUMINATED. 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 FAILURE TO DETACH WAS CONFIRMED SINCE THE DPU FAILED ELECTRICAL TESTING. THE MOST LIKELY CONTRIBUTING FACTOR TO THE MICROCOIL SYSTEM FAILURE TO BE DETACHED INSIDE THE ANEURYSM MAY HAVE BEEN DUE TO A FRACTURE OF THE SOLDER JOINT CONNECTION INSIDE THE RESISTIVE HEATING COIL SECTION. THE CIRCUMSTANCES OF HOW AND WHEN THIS DAMAGE OCCURRED CANNOT BE DETERMINED AS ALL MICROCOIL SYSTEMS ARE ELECTRICALLY TESTED PRIOR TO FINAL PACKAGING. SINCE THERE IS NO EVIDENCE THAT THE EVENT WAS RELATED TO A MANUFACTURING ISSUE, AND ALL DEVICES ARE TESTED FOR THIS FAILURE PRIOR TO BEING RELEASED FROM THE MANUFACTURING FACILITY, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    DURING COIL EMBOLIZATION OF AN ANTERIOR COMMUNICATING ARTERY ANEURYSM, A GALAXY G2 (641HX0204/ C19389) FAILED TO DETACH. THE COIL WAS ALMOST THE LAST COIL TO BE PLACED IN THE ANEURYSM. UPON ATTEMPTING TO DETACH THE COIL, NO SIGNAL WAS SEEN ON THE DETACHMENT BOX USED. THE DETACHMENT CABLE WAS EXCHANGED AND AGAIN THERE WAS NO SIGNAL DURING ATTEMPTED DETACHMENT. THEREFORE, THE PHYSICIAN RECAPTURED THE COIL AND USED ANOTHER COIL TO CONTINUE THE PROCEDURE. PRIOR TO LOADING THE NEW COIL INTO THE MICROCATHETER, HE CONNECTED THE PROXIMAL DETACHMENT PART OF THE COIL DELIVERY WIRE TO THE CONNECTING CABLE TO CONFIRM THAT THE DEVICE WAS WORKING, AND THERE WERE WAS A SIGNAL ON THE DETACHMENT BOX. THE SAME CABLE AND DETACHMENT CONTROL BOX USED WITH THE COMPLAINT PRODUCT WAS USED TO COMPLETE THE PROCEDURE. THE EVENT RESULTED IN A 5 MINUTE DELAY IN THE PROCEDURE, BUT NO PATIENT ADVERSE EVENT. THE PROCEDURE WAS CONTINUED WITH A SIMILAR PRODUCT. IT WAS REPORTED THAT A PRE-DEPLOYMENT ELECTRICAL CHECK HAD NOT BEEN PERFORMED. THE ACTUAL COIL DID NOT APPEAR DAMAGED. THE DEVICE HAD BEEN STORED AS PER THE LABELING INSTRUCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347707 ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM ARTIFICIAL EMBOLIZATION DEVICE HCG CODMAN AND SHURTLEFF, INC C19389

    Patients

    Seq Age Sex Outcome Treatment
    1