BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFILL DCS ORBIT MINI COMPLEX FILL

    MDR report key: 2122088 · Received June 13, 2011

    Report

    Report Number
    1058196-2011-00290
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    April 15, 2011
    Report Date
    April 19, 2011
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    HCG
    PMA / PMN Number
    K053197
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A NON-STERILE TRUFILL DCS ORBIT WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. THE HYPOTUBE WAS INSPECTED AND IT WAS FOUND KINKED. THE INTRODUCER WAS RECEIVED ZIPPED WITHOUT DAMAGE. THE SUPPORT COIL, GRIPPER AND EMBOLIC COIL WERE FOUND OUTSIDE OF THE INTRODUCER. THE SUPPORT COIL AND GRIPPER WERE FOUND WITHOUT DAMAGE WHILE THE EMBOLIC COIL WAS FOUND STRETCHED AND IT WAS STILL ATTACHED TO THE GRIPPER. THE GRIPPER AND THE EMBOLIC COIL WERE INSPECTED UNDER MICROSCOPE, THE GRIPPER WAS FOUND WITHOUT DAMAGE WHILE THE EMBOLIC COIL WAS FOUND STRETCHED. THE OD FROM THE DELIVERY TUBE WAS MEASURED AND WAS FOUND WITHIN SPECIFICATION. ONE MICROCATHETER PROWLER SELECT PLUS (CORDIS LAB SAMPLE) WAS FLUSHED USING A LAB SAMPLE SYRINGE (NIPRO), AFTER THAT THE RECEIVED TRUFILL DCS ORBIT WAS INTRODUCED INTO THE MICROCATHETER AND EVEN THE DAMAGES FOUND ON THE TRUFILL DCS IT CAN PASS THROUGH AND ADVANCED SMOOTHLY UNTIL THE MICROCATHETER'S DISTAL TIP. 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 IMPEDED IN MICRO CATHETER" WAS NOT CONFIRMED DURING THE ANALYSIS. THE CAUSE OF THE FAILURE EXPERIENCED AND THE DAMAGES FOUND ON THE DEVICE WAS DUE TO IT WAS USED A MICROCATHETER PROWLER 10 AND IS NOT RECOMMENDED ACCORDING TO THE IFU. 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 PREVENT THIS KIND OF FAILURES LEAVING FROM THE FACILITY. THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFR REPORT 1058196-2011-00290 AND 1058196-2011-00235. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT AFTER THE PROWLER 10 WAS USED TO ACCESS THE CAVERNOUS CAROTID ARTERY ANEURYSM, FOUR ORBIT COILS ((B)(4)) WERE UNABLE TO BE ADVANCED. AFTER THE FOURTH COIL WOULD NOT ADVANCE, THE MICROCATHETER WAS REMOVED AND THE CASE WAS DISCONTINUED. A NON-STERILE TRUFILL DCS ORBIT WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. THE HYPOTUBE WAS INSPECTED AND IT WAS FOUND KINKED. THE INTRODUCER WAS RECEIVED ZIPPED WITHOUT DAMAGE. THE SUPPORT COIL, GRIPPER AND EMBOLIC COIL WERE FOUND OUTSIDE OF THE INTRODUCER. THE SUPPORT COIL AND GRIPPER WERE FOUND WITHOUT DAMAGE WHILE THE EMBOLIC COIL WAS FOUND STRETCHED AND IT WAS STILL ATTACHED TO THE GRIPPER. THE GRIPPER AND THE EMBOLIC COIL WERE INSPECTED UNDER MICROSCOPE, THE GRIPPER WAS FOUND WITHOUT DAMAGE WHILE THE EMBOLIC COIL WAS FOUND STRETCHED. THE OD FROM THE DELIVERY TUBE WAS MEASURED AND WAS FOUND WITHIN SPECIFICATION. A LAB SAMPLE PROWLER SELECT PLUS (CORDIS LAB SAMPLE) WAS FLUSHED USING A LAB SAMPLE SYRINGE (NIPRO), AFTER THAT THE RECEIVED TRUFILL DCS ORBIT WAS INTRODUCED INTO THE MICROCATHETER AND EVEN WITH THE DAMAGES FOUND ON THE TRUFILL DCS IT COULD PASS THROUGH AND ADVANCED SMOOTHLY TO THE MICROCATHETER'S DISTAL TIP. 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. WITH FUNCTIONAL TESTING INSERTION DIFFICULTY INTO A COMPATIBLE MICROCATHETER WAS NOT CONFIRMED. THE TRUFILL DCS ORBIT INSTRUCTIONS FOR USE (IFU) OUTLINES THAT THE DEVICE IS DESIGNED FOR USE UNDER FLUOROSCOPY WITH A .014" OR .018" GUIDEWIRE COMPATIBLE INFUSION CATHETER 150 CM LONG, DUAL MARKER BAND SUCH AS PROWLER 14, PROWLER SELECT LPES, PROWLER PLUS, PROWLER SELECT PLUS, AND RAPID TRANSIT. THE PROWLER 10 INSTRUCTIONS FOR USE OUTLINES THAT IT IS INDICATED FOR USE WITH A MAXIMUM O.D. GUIDEWIRE OF 0.012". BASED ON THE ANALYSIS OF THE RETURNED DEVICES THE INABILITY TO INSERT THE ORBIT COILS THROUGH THE PROWLER 10 MICROCATHETER WAS DUE TO PROCEDURAL USE WITH A MICROCATHETER WITH AN ID THAT IS LESS THAN SPECIFIED FOR USE WITH THE TRUFILL DCS ORBIT. THIS SAME FACTOR LIKELY CONTRIBUTED TO THE STRETCHED CONDITION OF THE RETURNED (B)(4) ORBIT. INSPECTIONS ARE IN PLACE TO PREVENT DAMAGED DEVICES FROM LEAVING THE MANUFACTURING FACILITY. THERE IS NO INDICATION OF ANY MANUFACTURING ISSUES RELATED TO THE EVENTS. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2011-00290 AND 1058196-2011-00235.

    Description of Event or Problem · 1

    DURING A COIL EMBOLIZATION PROCEDURE, THE PROWLER 10 WAS USED TO ACCESS CC ANEURYSM AND THE ORBIT COMPLEX FILL COILS (637CF609/15092388, 637MF3505/14123264, 637MF3575/14125808, AND 638CS0721/15134727) WERE UNABLE TO ADVANCE. AFTER THE FOURTH COIL WOULD NOT ADVANCE, THE MICROCATHETER WAS REMOVED AND THE CASE WAS DISCONTINUED. DURING THE ANALYSIS, ORBIT MINI COMPLEX FILL 3.5X5 (637MF3505/14123264) COIL WAS STRETCHED.

    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 14123264

    Patients

    Seq Age Sex Outcome Treatment
    1 PROWLER MICROCATHETER