BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROWLER SELECT MICROCATHETERS

    MDR report key: 3851611 · Received June 5, 2014

    Report

    Report Number
    1058196-2014-00168
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    April 18, 2014
    Report Date
    April 21, 2014
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    KRA
    PMA / PMN Number
    K021591
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF LOT 15832410 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE PRODUCT IS AVAILABLE FOR EVALUATION AND TESTING, HOWEVER THE ANALYSIS HAS NOT BEEN COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    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 COIL WAS RETURNED DETACHED AND INSIDE THE RETURNED MICROCATHETER. A COMPLETE BLOCKAGE WAS LOCATED 117.0CM OFF THE PROXIMAL END. SEVEN DAYS OF ULTRASONIC CLEANING FAILED TO REMOVE THE BLOOD PLUGS INSIDE THE MICROCATHETER. A PORTION OF THE FIRST SECONDARY COILING OFF THE BALL TIP WAS FOUND PROTRUDING OUTSIDE THE PROWLER SELECT LPES MICROCATHETER. THE MICROCOIL SYSTEM WAS FULLY UNSHEATHED WITH THE FIRST SECONDARY WINDING OUTSIDE THE DISTAL TIP OF THE MICROCATHETER. NO DAMAGE OR MANUFACTURING DEFECTS WERE FOUND TO THE RETURNED MICROCATHETER PRIOR TO ITS DESTRUCTION IN ORDER TO REMOVE THE COIL. A COPIOUS AMOUNT OF A BLOOD PLUG WAS FOUND INSIDE THE DISSECTED MICROCATHETER. THE COIL WAS FOUND TO HAVE BEEN DAMAGED, HOWEVER IT CANNOT BE DETERMINED HOW MUCH COIL DAMAGE, IF ANY, WAS PRESENT PRIOR TO THE MICROCATHETERS DESTRUCTION IN ORDER TO REMOVE THE COIL. A PORTION OF THE COIL DAMAGE OCCURRED DURING ITS REMOVAL FROM THE DISSECTED MICROCATHETER. STRETCHING, BUCKLING, AND COMPRESSION DAMAGE WERE FOUND TO THE COIL. IT IS VERIFIED THAT THE UNINTENDED DETACHMENT INSIDE THE MICROCATHETER WAS MECHANICAL IN NATURE. FUNCTIONAL TESTING FOR THE MICROCATHETER COULD NOT BE PERFORMED DUE TO THE FIXED PRESENCE OF THE COIL WITHIN THE INNER LUMEN. AFTER CUTTING OF THE MICROCATHETER FOR REMOVAL OF THE COIL FIXED COIL, THE OD AND ID OF THE SECTIONS WERE MEASURED AND WERE FOUND WITHIN SPECIFICATION. THERE ARE THREE POSSIBLE CONTRIBUTING FACTORS TO THE COILS UNINTENDED DETACHMENT INSIDE THE MICROCATHETER. THESE CONTRIBUTING FACTORS MAY HAVE WORKED SEPARATELY OR IN TANDEM WITH EACH CAPABLE OF PRODUCING SIMILAR RESULTS. THE PRIMARY CONTRIBUTING FACTOR TO THE COILS UNINTENDED DETACHMENT INSIDE THE MICROCATHETER MAY HAVE BEEN DUE TO THE COIL BECOMING TEMPORARILY ANCHORED DURING REMOVAL. IF THE COIL WAS STILL PARTIALLY INSIDE THE ANEURYSM, THEN THE COIL MAY HAVE BECOME ANCHORED ON ITSELF, THE DISTAL TIP OF THE MICROCATHETER, OR ON OTHER COILS THAT WERE DWELLING INSIDE THE ANEURYSM IF THEY WERE PLACED PRIOR TO THE COMPLAINT COIL. THE INSTRUCTIONS FOR USE CAUTIONS ¿IF REPOSITIONING OF THE MICROCOIL IS NECESSARY, CAREFULLY OBSERVE THE MOTION OF THE MICROCOIL IN RESPECT TO THE DPU WIRE WHILE RETRACTING THE MICROCOIL UNDER FLUOROSCOPY. IF THE MICROCOIL MOVEMENT IS NOT ONE-TO-ONE WITH THE DPU WIRE, OR IF REPOSITIONING IS DIFFICULT, THE MICROCOIL MAY HAVE BECOME STRETCHED AND COULD POSSIBLY BREAK. GENTLY REMOVE AND DISCARD THE MICROCOIL SYSTEM. CAUTION: IF THE MICROCOIL IS POSITIONED AT A RELATIVE SHARP ANGLE TO THE MICROCATHETER, A MICROCOIL MAY STRETCH OR BREAK AS IT IS BEING WITHDRAWN. BY REPOSITIONING THE DISTAL TIP OF THE CATHETER AT OR SLIGHTLY INSIDE THE OSTIUM OF THE ANEURYSM, THE MICROCOIL MAY BE MORE EASILY FUNNELED BACK INTO THE MICROCATHETER.¿ THE SECONDARY CONTRIBUTING FACTOR TO THE COILS UNINTENDED DETACHMENT INSIDE THE MICROCATHETER MAY HAVE BEEN DUE TO THE SELECTION OF A NON-COMPATIBLE MICROCATHETER THAT WAS USED WITH AN 18 SERIES MICROCOIL SYSTEM. THE INSTRUCTIONS FOR USE OUTLINES ¿PROPER SELECTION OF THE APPROPRIATELY SIZED MICROCATHETER IS REQUIRED TO AVOID DAMAGE TO THE CODMAN MICROCOIL SYSTEM AND TO MINIMIZE POTENTIAL COMPLICATIONS. ¿THE MICROCOIL INSTRUCTIONS FOR USE OUTLINES THAT THE MICROCOIL 18 SYSTEM IS COMPATIBLE WITH MICROCATHETERS WITH INNER LUMEN DIAMETERS RANGING FROM 0.017 TO 0.021 IN (0.356 TO 0.533 MM). THE INNER LUMEN OF THE PROWLER SELECT LPES MICROCATHETER IS 0.0165¿ AS OUTLINED IN THE INSTRUCTIONS FOR USE. A THIRD CONTRIBUTING FACTOR MAY HAVE BEEN FROM THE BLOOD PLUG THAT PREVENTED THE REMOVAL OF THE COIL FROM THE MICROCATHETER. IT WAS STATED THAT THERE WAS A HIGH RATE OF BLOOD FLOW IN THE ARTERY. THE BLOOD FLOW MAY HAVE EXCEEDED THE PRESSURIZED SALINE FLOW OR THE CONSTANT SALINE FLOW INTO THE MICROCATHETER MAY HAVE ALSO BEEN TEMPORARILY INTERRUPTED. THE INSTRUCTIONS FOR USE FOR THE MICROCOIL SYSTEM OUTLINES THAT TO ACHIEVE OPTIMAL PERFORMANCE OF THE CODMAN MICROCOIL SYSTEM, IT IS IMPORTANT THAT A CONTINUOUS INFUSION OF AN APPROPRIATE FLUSH SOLUTION BE MAINTAINED THROUGH THE MICROCATHETER. THE INSTRUCTIONS FOR USE FOR THE MICROCATHETER ALSO OUTLINES THAT A CONTINUOUS FLUSH IS REQUIRED DURING THE PROCEDURE. DETACHMENT OF THE COIL WITHIN THE MICROCATHETER WAS CONFIRMED. ALTHOUGH IT WAS REPORTED THAT A CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER, BASED ON THE ANALYSIS FINDING OF DRIED BLOOD PLUGS WITHIN THE MICROCATHETER LUMEN IT APPEARS THAT NOT MAINTAINING AN ADEQUATE FLUSH AS OUTLINED IN THE INSTRUCTIONS FOR USE WAS A CONTRIBUTING FACTOR. ADDITIONALLY, THE USE OF A THE MICROCATHETER WITH AN ID LESS THAN INDICATED AS COMPATIBLE WITH THE 18 MICROCOIL SYSTEM IS ANOTHER IDENTIFIED CONTRIBUTING FACTOR. WITH REVIEW OF THE REPORTED INFORMATION, THE DEVICE HISTORY RECORDS AND THE ANALYSIS OF THE RETURNED DEVICES, THERE IS NO INDICATION OF ANY MANUFACTURING ISSUES IMPACTING THE EVENT. PROCEDURAL FACTORS ADDRESSED IN THE LABELING OF THE DEVICES APPEAR TO HAVE CONTRIBUTED OR CAUSED THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    DURING COIL EMBOLISATION OF THE PROPER HEPATIC ARTERY WHEN THE PHYSICIAN WAS PLACING A HELIPAQ ((B)(4)) INTO THE TARGET LESION, HE ENCOUNTERED DIFFICULTIES PLACING THE COIL DUE TO HIGH BLOOD FLOW IN THE ARTERY. THE ARTERY WAS NOT CALCIFIED AND NOT TORTUOUS. THE PHYSICIAN WANTED TO RE-SHEATH THE COIL. HOWEVER, WHILE WITHDRAWING THE HELIPAQ FROM THE PATIENT, THE COIL DETACHED AROUND THE MIDDLE SECTION OF THE PROWLER SELECT LPES((B)(4)) ALTHOUGH NO DETACHMENT WAS ATTEMPTED AT THAT TIME. THEREFORE BOTH THE ENTIRE HELIPAQ AND THE PROWLER SELECT LPES WERE SAFELY REMOVED AS A UNIT FROM THE PATIENT. THE PROCEDURE WAS CONTINUED USING A NEW COIL ((B)(4), LOT UNKNOWN). IT IS UNKNOWN WHETHER THE MICROCATHETER WAS REPLACED OR NOT. IT IS UNKNOWN WHETHER OTHER COILS WERE SUCCESSFULLY DELIVERED WITH THE SAME MICROCATHETER. AFTERWARDS, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY FURTHER ISSUES. THERE WAS NO PATIENT INJURY/COMPLICATIONS REPORTED. THE COMPLAINT PRODUCTS WERE NEW AND WERE STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND THE CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIMES. PRIOR TO USE, NO DEFECT (KINK, BENDS ETC) WAS NOTED ON THE PRODUCTS BY VISUAL INSPECTION. IT IS UNKNOWN IF THE MICROCATHETER WAS RE-SHAPED OR NOT. THE MICROCATHETER WAS NOT KINKED DURING THE EVENT. THE COMPLAINT PRODUCTS ARE GOING TO BE RETURNED FOR EVALUATION. THERE WAS NO DAMAGE SEEN ON THE PRODUCTS AFTER REMOVAL FROM THE PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329457 PROWLER SELECT MICROCATHETERS CES MICROCATHETERS (KRA) KRA CORDIS NEUROVASCULAR, INC. NA 15832410

    Patients

    Seq Age Sex Outcome Treatment
    1