BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROWLER MICROCATHETERS

    MDR report key: 2467158 · Received February 24, 2012

    Report

    Report Number
    1058196-2012-00099
    Event Type
    Malfunction
    Date Received
    February 24, 2012
    Date of Event
    February 17, 2012
    Report Date
    February 18, 2012
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    KRA
    PMA / PMN Number
    K972518
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A COIL EMBOLIZATION OF A 5.3X11MM POSTERIOR COMMUNICATING (PCOM) ANEURYSM WITH SUBARACHNOID HEMORRHAGE (SAH), WHILE DELIVERING THE 5X15 ORBIT RDFL COMPLEX FILL COIL THROUGH THE PROWLER 14 MICROCATHETER (MC) THE COIL PREMATURELY DETACHED IN THE MC. BOTH DEVICES WERE REMOVED AS A UNIT FOR SAFETY CONCERNS, AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO DAMAGES ON THE MC THAT MAY HAVE CONTRIBUTED TO THE EVENT, AND DURING THE EVENT, NO ADDITIONAL FORCE WAS UTILIZED AT ANY TIME. NO RESISTANCE WAS NOTED WHEN INSERTING/ADVANCING THE COIL IN THE MC OR ANY OTHER TIME. CONSTANT FLUOROSCOPY WAS PERFORMED AT ALL TIMES, AND AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MC AT ALL TIMES. AFTER THE EVENT, THE SAME MC WAS NOT UTILIZED TO COMPLETE THE PROCEDURE. AFTER REMOVAL FROM THE PATIENT, OTHER THAN THE REPORTED EVENT, NO OTHER DAMAGES WERE NOTICED ON ANY OF THE DEVICES (COIL DELIVERY SYSTEM- FRACTURES, SEPARATED, ETC, DISTAL TIPS -UNRAVELED, STRETCHED, KINKS, BENDS, FRACTURES, ETC, COIL-FRACTURE, SEPARATED, STRETCHED, UNRAVELED, KINK, BEND, ETC). ONE NON-STERILE PROWLER 14 150CM DUAL MARKER MICROCATHETER (MC) WAS RECEIVED COILED INSIDE A PLASTIC BAG; THE UNIT WAS RECEIVED SEPARATED AT 122CM FROM HUB, THE MC WAS FOUND SEVERELY DAMAGED (IN BOTH PARTS); IT WAS COMPRESSED AND TWISTED. AN EMBOLIC COIL WAS FOUND THROUGH THE MC ALMOST COMPLETELY OUTSIDE OF IT; ALSO THE UNIT WAS FOUND INSERTED ON AN UNKNOWN CSI. DAMAGED SECTIONS OF THE MC WERE OBSERVED UNDER THE MICROSCOPE AND IN ADDITION TO THE PREVIOUSLY NOTED DAMAGES, IT WAS NOTED THAT IT WAS STRETCHED; THIS STRETCHING APPEARS TO HAVE BEEN THE CAUSE FOR THE CATHETER SEPARATION. THE EXACT CAUSE OF THESE DAMAGES COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, IT WAS REPORTED THAT AFTER REMOVAL FROM THE PATIENT THERE WERE NO DAMAGES NOTED ON THE DEVICE; THEREFORE, IT CAN BE DETERMINED THAT THE DAMAGED CONDITION OF THE MC OCCURRED POST PROCEDURAL USE. THE ID OF MICROCATHETER WAS MEASURED AND WAS FOUND WITHIN SPECIFICATION. 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 PREMATURE DETACHMENT OF THE ORBIT COIL IN THE PROWLER 14 MC WAS CONFIRMED WITH ANALYSIS OF THE RETURNED DEVICES. ALTHOUGH IT WAS REPORTED THAT AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MC, BASED ON THE ANALYSIS, IT APPEARS THAT THE RESIDUES OF DRIED BLOOD FOUND IN THE MC AND ON THE COIL CAUSED OR CONTRIBUTED TO THE EVENT. THE INSTRUCTIONS FOR USE OUTLINES THAT IN ORDER TO ACHIEVE OPTIMAL PERFORMANCE OF THE MC AND ORBIT SYSTEM AND TO REDUCE RISK OF THROMBOEMBOLIC COMPLICATIONS, IT IS CRITICAL THAT A CONTINUOUS INFUSION OF APPROPRIATE FLUSH SOLUTION BE MAINTAINED BETWEEN THE INFUSION CATHETER (MC) AND THE STEERABLE GUIDEWIRE OR THE ORBIT DETACHABLE COIL. BASED ON THE REPORTED INFORMATION, THE ANALYSIS OF THE RETURNED DEVICES AND THE DEVICE HISTORY RECORDS, THERE IS NO INDICATION OF ANY MANUFACTURING ISSUES RELATED TO THE EVENT OR DAMAGES FOUND ON THE RETURNED DEVICES. PROCEDURAL FACTORS APPEAR TO HAVE CONTRIBUTED TO THE PREMATURE DETACHMENT. 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 1058196-2012-00098 & 1058196-2012-00099.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WILL BE RETURNED FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2012-00098 AND 1058196-2012-00099.

    Description of Event or Problem · 1

    DURING A COIL EMBOLIZATION PROCEDURE OF THE SAH/ANEURYSM (5.3 11MM) OF THE PCOM, WHILE DELIVERING AN ORBIT RDFL COMPLEX FILL COIL ((B)(4)/ 15358304) THROUGH THE PROWLER 14 (MC) MICROCATHETER (606151X/ 15217423) TO THE TARGET SITE, THE COIL AUTO-RELEASED IN THE MICROCATHETER. BOTH DEVICES WERE REMOVED AS A UNIT FOR SAFETY CONCERNS, AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO DAMAGES ON THE MC THAT MAY HAVE CONTRIBUTED TO THE EVENT, AND DURING THE EVENT, NO ADDITIONAL FORCE WAS UTILIZED AT ANY TIME. DURING ADVANCING OF THE COIL DELIVERY SYSTEM THROUGH THE MICROCATHETER, NO RESISTANCE WAS NOTED WHEN INSERTING/ADVANCING THE COIL IN THE MC OR ANY OTHER TIME. CONSTANT FLUOROSCOPY WAS PERFORMED AT ALL TIMES, AND AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MC AT ALL TIMES. AFTER THE EVENT, THE SAME MICROCATHETER WAS NOT UTILIZED TO COMPLETE THE PROCEDURE. AFTER REMOVAL FROM THE PATIENT, OTHER THAN THE REPORTED EVENT, NO OTHER DAMAGES WERE NOTICED ON ANY OF THE DEVICES (COIL DELIVERY SYSTEM- FRACTURES, SEPARATED, ETC, DISTAL TIPS -UNRAVELED, STRETCHED, KINKS, BENDS, FRACTURES, ETC, COIL-FRACTURE, SEPARATED, STRETCHED, UNRAVELED, KINK, BEND, ETC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROWLER MICROCATHETERS CES MICROCATHETERS (KRA) KRA CORDIS NEUROVASCULAR, INC. NA 15217423

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR ORBIT COIL