BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX

    MDR report key: 2052402 · Received April 13, 2011

    Report

    Report Number
    1058196-2011-00162
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    March 11, 2011
    Report Date
    March 30, 2011
    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

    A NON-STERILE TRUFILL DCS ORBIT WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. HYPOTUBE WAS INSPECTED AND SEVERAL KINKS WERE FOUND ON IT. INTRODUCER WAS RECEIVED UNZIPPED WITH WAVE CONDITION. THE SUPPORT COIL, GRIPPER AND EMBOLIC COIL WERE FOUND OUTSIDE OF THE INTRODUCER WITHOUT DAMAGE. THE EMBOLIC COIL WAS STILL ATTACHED TO THE GRIPPER. USING A LAB SAMPLE SYRINGE (B)(4), THE TRUFILL DCS SYSTEM WAS PURGING ON THE BLUE ZONE; AFTER THAT AND EVEN THE DAMAGES FOUND ON THE DEVICE, THE EMBOLIC COIL WAS DETACHED WHEN THE NEEDLE OF THE PRESSURE GAUGE WAS ON THE GREEN ZONE. THE GRIPPER AND EMBOLIC COIL WERE INSPECTED UNDER MICROSCOPE AND NO DAMAGES WERE FOUND ON THEM. 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 FAILURE REPORTED BY THE COSTUMER AS "COIL- FAILURE TO DETACH" WAS NOT CONFIRMED DURING THE ANALYSIS. THE CAUSE OF THE DAMAGES FOUND ON THE DEVICE COULD NOT BE CONCLUSIVELY DETERMINED. NEITHER THE ANALYSIS NOR THE DHR SUGGEST THAT THE FAILURE REPORTED COULD BE RELATED TO THE MANUFACTURING PROCESS; PROCEDURAL AND HANDLING FACTORS APPEAR TO HAVE CONTRIBUTED TO THESE DAMAGES. ADDITIONALLY INSPECTIONS ARE IN PLACE THAT PREVENTS THESE KINDS OF FAILURES LEAVING FROM THE FACILITY. THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    THE 10X30 TRUFILL DCS ORBIT RDFL COMPLEX STANDARD (638CS1030) WAS NOT ABLE TO BE DETACHED USING THE TRUFILL DCS SYRINGE II (635-002) DESPITE ATTEMPTING THE ALTERNATIVE DETACHMENT METHOD. THE COIL WAS NOT DETACHED EVEN AFTER THE SYRINGE WAS REPLACED WITH A NEW PRODUCT. THE COIL WAS REPLACED WITH A NEW PRODUCT WHICH WAS SUCCESSFULLY DETACHED. THE COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM WHEN REMOVED. THE PROCEDURE WAS COMPLETED WITHOUT ADVERSE CONSEQUENCE TO THE PATIENT. THE PROCEDURE WAS AN ENTERPRISE VRD ASSISTED COIL EMBOLIZATION OF THE INTERNAL CAROTID ARTERY (IC C2). A DEDICATED SALINE SOURCE WAS UTILIZED TO FILL THE SYRINGE, AND CONSTANT AND DEDICATED HEPARINIZED SALINE SOURCE UTILIZED AT ALL TIMES. THE SYRINGE WAS CONNECTED PROPERLY WITH EACH DELIVERY SYSTEM HUB. PRIOR TO THE FAILURE TO DETACHED, THE SYRINGE WAS NOT TAKEN PAST THE GREEN ZONE, POSITION 3, OR EXCEEDED RED ZONE. NO LEAKS WERE NOTICED ANYWHERE ON THE DELIVERY SYSTEM OR SYRINGE. AFTER THE EVENT, NO DAMAGES WERE NOTICED ON THE SYRINGE, COIL OR DELIVERY SYSTEM. THE SAME SYRINGE WAS UTILIZED WITH OTHER PRODUCTS. THE COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM. NO FURTHER INFORMATION IS AVAILABLE. A NON-STERILE TRUFILL DCS ORBIT WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. HYPOTUBE WAS INSPECTED AND SEVERAL KINKS WERE FOUND ON IT. INTRODUCER WAS RECEIVED UNZIPPED WITH WAVE CONDITION. THE CAUSE OF THESE DAMAGES AND THE TIMING AS RELATED TO PROCEDURAL USE COULD NOT BE CONCLUSIVELY DETERMINED. IT APPEARS THAT PROCEDURAL OR POST PROCEDURAL HANDLING FACTORS CONTRIBUTED TO THESE DAMAGES. THE SUPPORT COIL, GRIPPER AND EMBOLIC COIL WERE FOUND OUTSIDE OF THE INTRODUCER WITHOUT DAMAGE. THE EMBOLIC COIL WAS STILL ATTACHED TO THE GRIPPER. USING A LAB SAMPLE SYRINGE 635-002, THE TRUFILL DCS SYSTEM WAS PURGED BY PRESSURIZING TO THE BLUE ZONE. AFTER THAT, EVEN WITH THE DAMAGES FOUND ON THE DEVICE, THE EMBOLIC COIL WAS DETACHED WHEN THE NEEDLE OF THE PRESSURE GAUGE WAS ON THE GREEN ZONE. THE GRIPPER AND EMBOLIC COIL WERE INSPECTED UNDER MICROSCOPE AND NO DAMAGES WERE FOUND ON THEM. 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. BASED ON THE AVAILABLE PROCEDURAL INFORMATION THERE ARE NO IDENTIFIED CONTRIBUTING FACTORS. THE REPORTED FAILURE OF THE COIL TO DETACH WAS NOT CONFIRMED WITH FUNCTIONAL TESTING OF THE RETURNED DEVICE. NEITHER THE ANALYSIS NOR THE DEVICE HISTORY RECORDS REVIEW SUGGESTS THAT THE REPORTED EVENT IS RELATED TO THE MANUFACTURING PROCESS OF THE ORBIT COIL SYSTEM. ADDITIONALLY INSPECTIONS ARE IN PLACE TO PREVENT THIS TYPE OF FAILURE FROM LEAVING FROM THE FACILITY. THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    DURING A COIL EMBOLIZATION PROCEDURE USING AN ENTERPRISE VRD STENT (CATALOG#/LOT# UNKNOWN), THE ORBIT COIL (638CS1030) WAS NOT ABLE TO BE DETACHED WITH THE SYRINGE 635-002 (COMPLAINT PRODUCT 2) THOUGH ALTERNATIVE DETACHMENT WAS ATTEMPTED. THE COIL WAS NOT DETACHED EVEN AFTER THE SYRINGE WAS REPLACED WITH THE NEW PRODUCT. THE COIL WAS REPLACED AND THE NEW PRODUCT WAS SUCCESSFULLY DETACHED. THE PROCEDURE WAS COMPLETED WITHOUT ADVERSE CONSEQUENCE TO THE PATIENT. A DEDICATED SALINE SOURCE WAS UTILIZED TO FILL THE SYRINGE, AND CONSTANT AND DEDICATED HEPARINIZED SALINE SOURCE UTILIZED AT ALL TIMES. THE SYRINGE WAS CONNECTED PROPERLY WITH EACH DELIVERY SYSTEM HUB. PRIOR TO THE FAILURE TO DETACHED, THE SYRINGE WAS NOT TAKING PAST THE GREEN ZONE, POSITION 3 OR EXCEEDED RED ZONE. NO LEAKS WERE NOTICED ANYWHERE ON THE DELIVERY SYSTEM OR SYRINGE. AFTER THE EVENT, NO DAMAGES WERE NOTICED ON THE SYRINGE, COIL OR DELIVERY SYSTEM. THE SAME SYRINGE WAS UTILIZED WITH OTHER PRODUCTS. THE COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM. THE TARGET LESION WAS IC C2. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX CNV DCS ORBIT (HCG) HCG CORDIS NEUROVASCULAR, INC. NA 15244102

    Patients

    Seq Age Sex Outcome Treatment
    1 DCS SYRINGE