BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XTRASOFT ORBIT GALAXY DETACHABLE COIL

    MDR report key: 1852527 · Received October 4, 2010

    Report

    Report Number
    3007628272-2010-50004
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    September 7, 2010
    Report Date
    September 7, 2010
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    HCG
    PMA / PMN Number
    K093973
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PROWLER LPES MIOROCATHETER AND MICRUS COISL.ADDITIONAL INFORMATION WILL BE SUBMITTED WIHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    THE ORBIT GALAXY (640CX0306 LOT# 13500001) WAS ADVANCED THROUGH A PROWLER LPES MICROCATHETER INTO A TREMENDOUS ANEURYSM IN THE (ICA) INTERNAL CAROTID ARTERY, AND WHEN ATTEMPTED TO DETACH THE COIL, IT WOULD NOT DETACH WHEN THE SYRINGE WAS TAKEN UP TO GREEN TWICE THEN TO RED, READJUSTED FORWARD AND BACKWARD. TOGGLED AND THE SYRINGE WAS TAKEN AGAIN TO GREEN AND THEN RED WOULD NOT DETACHED. THE ORBIT GALAXY WAS REMOVED, AND ANOTHER ORBIT GALAXY (640CX0306 13500001) WAS DELIVER AND DETACHED WITHOUT ISSUES. THE PRODUCT WAS THROWN AWAY AFTER THE CASE. THE FIRST AND SECOND COILS USED WERE MICRUS SPHERICAL 5X9.6CM COILS. THE ALERT DATE FOR THE EVENT IS 09/07/10, AND THE LOT NUMBER WAS ON THE ORIGINAL COMPLAINT. A TOTAL OF 7 COILS WERE PLACED WITH THE SAME SYRINGE. PRIOR TO THIS COIL, OR ANY TIME PRIOR TO THE EVENT, THE SYRINGE WAS NOT TAKING PASSED THE GREEN ZONE POSITION #3 OR THE ALTERNATE DETACHMENT ZONE. THE SAME SYRINGE ALONG WITH ANOTHER SYRINGE WAS UTILIZED TO DETACHED COILS. A DEDICATED SALINE SOURCE WAS UTILIZED TO FILL THE SYRINGE, AND NO LEAKS WERE NOTICED ANYWHERE ON THE SYRINGE OR COIL DELIVERY SYSTEM. AFTER REMOVAL OF THE COIL DELIVERY SYSTEM, NO DAMAGES WERE NOTICED ON THE DEVICE. DURING PREP, ALL LABELING INSTRUCTIONS WERE FOLLOWED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE ORBIT GALAXY (640CX0306 LOT# 13500001) WAS ADVANCED THROUGH A PROWLER LPES MICROCATHETER INTO A TERMINUS INTERNAL CAROTID ARTERY (ICA) ANEURYSM. THE COIL WOULD NOT DETACH WHEN THE SYRINGE WAS TAKEN UP TO THE GREEN ZONE TWICE. IT WAS THEN TAKEN TO THE RED ZONE, READJUSTED FORWARD AND BACKWARD. IT WAS THEN TOGGLED AND THE SYRINGE WAS TAKEN AGAIN TO THE GREEN AND RED ZONE; HOWEVER, THE COIL WOULD NOT DETACH. THE ORBIT GALAXY WAS REMOVED AND ANOTHER ORBIT GALAXY FROM THE SAME LOT NUMBER WAS DELIVERED AND DETACHED WITHOUT ANY ISSUES. AFTER REMOVAL OF THE COIL DELIVERY SYSTEM, NO DAMAGES WERE NOTICED ON THE DEVICE. THE PRODUCT WAS THROWN AWAY AFTER THE CASE. THE FIRST COIL WAS A MICRUS SPHERICAL 5X9.6CM COIL, THE ORBIT WAS THE SECOND COIL. DURING PREP, ALL LABELING INSTRUCTIONS WERE FOLLOWED. A DEDICATED SALINE SOURCE WAS UTILIZED TO FILL THE SYRINGE, AND NO LEAKS WERE NOTICED ANYWHERE ON THE SYRINGE OR COIL DELIVERY SYSTEM. THE SYRINGE HAD NOT EXCEEDED THE GREEN ZONE PRIOR TO THIS. PRIOR TO THIS COIL THE SYRINGE WAS NOT TAKEN PASSED THE GREEN ZONE POSITION #3 OR THE ALTERNATE DETACHMENT ZONE. A TOTAL OF 7 COILS WERE PLACED WITH THE SAME SYRINGE. ALTHOUGH IT DID NOT IMPACT THIS EVENT, SINCE THIS WAS THE FIRST ORBIT COIL USED, THE INSTRUCTIONS FOR USE OUTLINES THAT IF ZONE #3 (GREEN ZONE) HAS NOT BEEN EXCEEDED, THE SYRINGE CAN SAFELY USED UP TO 5 COIL DETACHMENTS, OR ATTEMPTED COIL DETACHMENTS DURING A SINGLE CLINICAL PROCEDURE. IT FURTHER OUTLINES THAT IF ZONE #3 IS EXCEEDED, THE SYRINGE SHOULD NOT BE RE-USED. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 13500001 NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE DHR REVIEW INDICATES THAT THE PRODUCT WAS TESTED AND INSPECTED PER ESTABLISHED MANUFACTURING REQUIREMENTS INCLUDING INSPECTION RESULTS TEST AS PER EMBOLIC COIL ATTACHMENT PULL TEST (EAS), EMBOLIC COIL DETACHMENT PRESSURE TEST (CDP) AND EMBOLIC HEADPIECE ATTACHMENT STRENGTH PULL TEST. BASED ON THE AVAILABLE INFORMATION THERE ARE NO IDENTIFIED FACTORS THAT MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE OF THE GALAXY TO DETACH. WITHOUT THE RETURN OF THE DEVICE FOR ANALYSIS, NO CONCLUSION CAN BE MADE. THERE ARE NO IDENTIFIED MANUFACTURING ISSUES RELATED TO THE EVENT BASED ON THE DEVICE HISTORY RECORD REVIEW. AN INVESTIGATION INTO THIS ISSUE HAS BEEN INITIATED TO DETERMINE IF ANY ACTIONS ARE REQUIRED. ACTION WAS OPENED IN THE CODMAN SYSTEM TO INVESTIGATE THIS ISSUE.

    Description of Event or Problem · 1

    THE ORBIT GALAXY ((B)(4) LOT# 13500001) WAS ADVANCED THROUGH A PROWLER LPES MICROCATHETER INTO A TREMENDOUS ANEURYSM IN THE (ICA) INTERNAL CAROTID ARTERY, AND WHEN ATTEMPTED TO DETACH THE COIL, IT WOULD NOT DETACH WHEN THE SYRINGE WAS TAKEN UP TO GREEN TWICE THEN TO RED, READJUSTED FORWARD AND BACKWARD. TOGGLED AND THE SYRINGE WAS TAKEN AGAIN TO GREEN AND THEN RED WOULD NOT DETACHED. THE ORBIT GALAXY WAS REMOVED, AND ANOTHER ORBIT GALAXY ((B)(4) 13500001) WAS DELIVER AND DETACHED WITHOUT ISSUES. THE PRODUCT WAS THROWN AWAY AFTER THE CASE. THE FIRST AND SECOND COILS USED WERE MICRUS SPHERICAL 5X9.6CM COILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XTRASOFT ORBIT GALAXY DETACHABLE COIL ARTIFICIAL EMBOLIZATION DEVICE HCG CODMAN AND SHURTLEFF, INC 13500001

    Patients

    Seq Age Sex Outcome Treatment
    1