BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFILL DCS ORBIT MINI COMPLEX FILL

    MDR report key: 1962061 · Received January 17, 2011

    Report

    Report Number
    1058196-2011-00027
    Event Type
    Malfunction
    Date Received
    January 17, 2011
    Date of Event
    December 21, 2010
    Report Date
    December 21, 2010
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    HCG
    PMA / PMN Number
    K053197
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT DURING A CEREBRAL ANEURYSM EMBOLIZATION PROCEDURE A TRUFILL DCS COIL DID NOT DETACH AND WAS REMOVED WITHOUT INJURY TO THE PATIENT. DURING THE SAME PROCEDURE, A TRUFILL DCS COIL STRETCHED WHEN IT WAS PULLED BACK DURING REPOSITIONING IN THE ANEURYSM. IT THEN GOT CAUGHT ON THE TIP OF THE GUIDE CATHETER DURING REMOVAL FROM THE PATIENT AND PREMATURELY DETACHED. IT WAS ULTIMATELY REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH OTHER COILS WITHOUT PATIENT INJURY. THE TARGET LESION WAS AN ANTERIOR COMMUNICATING ARTERY (ACA) IN A (B)(6) FEMALE. THE ANEURYSM CHARACTERISTICS AND VESSEL DIAMETER ARE NOT KNOWN. THE VESSEL WAS MILDLY CALCIFIED AND MODERATELY TORTUOUS. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER (MC) AT ALL TIMES THROUGHOUT THE PROCEDURE. IT IS UNKNOWN IF THE MC WAS RE-SHAPED PRIOR TO USE. THERE WAS NO RESISTANCE BETWEEN THE GUIDEWIRE (GW) AND THE MC WHEN ACCESSING THE TARGET SITE. THERE WAS NO RESISTANCE AT ANY TIME DURING ADVANCEMENT OF THE COILS THROUGH THE MC. DURING THE COIL EMBOLIZATION PROCEDURE THE 2X1.5 TRUFILL DCS ORBIT MINI COMPLEX FILL COIL ((B)(4)) COULD NOT BE DETACHED AFTER USING TWO DIFFERENT DCS SYRINGES. THE COIL WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS CONTINUED USING OTHER COILS WITHOUT PATIENT INJURY. THE SYRINGE WAS TAKEN TO THE BLUE ZONE AND NOT EXCEEDED DURING PREP. ZONE#3 WAS NOT EXCEEDED. AFTER THE COIL DID NOT DETACHED, THE ALTERNATIVE DETACHMENT ZONE (RED) WAS UTILIZED TO DETACH THE COIL. THE PRODUCT WAS CONNECTED PROPERLY TO THE HUB OF THE COIL DELIVERY SYSTEM. THERE WAS NO LEAKAGE NOTED AT THE CONNECTOR, EXTENSION TUBING, DELIVERY SYSTEM HUB OR ANYWHERE ELSE. THE CONNECTOR WAS CHECKED FOR PROPER SEATING/FITTING ON THE DELIVERY SYSTEM HUB. AFTER DISCONNECTING THE COIL DELIVERY SYSTEM, THERE WAS NO DAMAGED NOTED ON THE SYRINGE. IT IS UNKNOWN HOW MANY COILS WERE DETACHED WITH THE SAME SYRINGE. A NON-STERILE TRUFILL ORBIT DCS WAS RECEIVED INSIDE OF A PLASTIC BAG. THE HYPOTUBE WAS INSPECTED AND SEVERAL KINKS FOUND ON IT. THE INTRODUCER WAS RECEIVED UNZIPPED WITHOUT DAMAGE. THE SUPPORT COIL, GRIPPER AND EMBOLIC COIL WERE FOUND OUTSIDE OF THE INTRODUCER WITHOUT DAMAGE. THE EMBOLIC COIL AND THE GRIPPER WERE INSPECTED UNDER MICROSCOPE AND NO DAMAGES WERE FOUND ON THEM. DEVICE WAS FLUSHED USING A LAB SAMPLE SYRINGE ((B)(4)) IN THE BLUE ZONE, AFTER THAT THE PRESSURE WAS INCREASE UNTIL THE GREEN ZONE AND AT THIS TIME THE EMBOLIC COIL WAS DETACHED WITHOUT ANY ANOMALY. 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. THE REPORTED FAILURE OF THE COIL TO DETACH WAS NOT CONFIRMED WITH FUNCTIONAL TESTING OF THE RETURNED DEVICE. THE CAUSE OF THE KINKS IN THE HYPOTUBE COULD NOT BE CONCLUSIVELY DETERMINED, HOWEVER THIS DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS, PROCEDURAL OR POST PROCEDURAL FACTORS APPEAR TO HAVE CONTRIBUTED TO HAVE THESE DAMAGES. INSPECTIONS ARE IN PLACE TO PREVENT THIS KIND OF FAILURES LEAVING FROM THE FACILITY. BASED ON THE AVAILABLE INFORMATION AND THE ANALYSIS OF THE RETURNED DEVICE, NO CONCLUSION CAN BE MADE REGARDING THE REPORTED INABILITY TO DETACH THE COIL; THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF TWO PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG. REPORT # 1058196-2011-00027 AND 1058196-2011-00028.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION HAS NOT BEEN COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF TWO PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFR REPORTS # 1058196-2011-00027 AND 1058196-2011-00028.

    Description of Event or Problem · 1

    DURING A CEREBRAL ARTERY EMBOLIZATION PROCEDURE, AN EMBOLIC COIL UNRAVELED AND DETACHED EARLY WHEN IT BECAME STUCK IN THE TIP OF THE GUIDING CATHETER. THE VESSEL WAS MILDLY CALCIFIED AND MODERATELY TORTUOUS. THE PATIENT WAS A (B)(6) FEMALE. THE TARGET LESION WAS THE ANTERIOR COMMUNICATING ARTERY (ACA). THE FIRST ORBIT COIL (637MF0201/ LOT 15165671) COULD NOT BE DETACHED. THE CATALOG/LOT NUMBER OF THE DCS SYRINGE WAS UNKNOWN. ALTHOUGH ATTEMPT WAS MADE BY ANOTHER NEW SYRINGE, THE COIL COULD NOT BE DETACHED. THE COIL WAS REMOVED FROM THE PATIENT AND CHANGED TO ANOTHER NEW COIL. THE PROCEDURE CONTINUED. DURING THE PROCEDURE, ANOTHER ORBIT COIL (637MF0202/ LOT 15163627) WAS USED. THE COIL WAS PULLED BACK, BUT IT BECAME UNRAVELED. AS THE COIL WAS BEING REMOVED WITH MICROCATHETER AS A UNIT, THE EMBOLIC COIL BECAME STUCK IN THE TIP OF THE GUIDING CATHETER (ENVOY 5F MPD) AND DETACHED EARLY. AN OCCLUSION BALLOON (SENTRY, BOSTON SCIENTIFIC) WAS USED AND INFLATED INSIDE THE GUIDING CATHETER TO HOLD THE COIL IN THE CATHETER, AND ALL THE SYSTEM WAS REMOVED FROM THE PATIENT SUCCESSFULLY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH OTHER NEW PRODUCTS WITHOUT ANY PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUFILL DCS ORBIT MINI COMPLEX FILL CNV DCS ORBIT (HCG) HCG CORDIS NEUROVASCULAR, INC. NA 15165671

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR GUIDING CATHETER (ENVOY 5F MPD)