BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROWLER SELECT MICROCATHETERS

    MDR report key: 2000533 · Received February 24, 2011

    Report

    Report Number
    1058196-2011-00068
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    December 10, 2010
    Report Date
    February 11, 2011
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    KRA
    PMA / PMN Number
    K021591
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    A NON-STERILE PROWLER SELECT PLUS WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. FLATTENED AND COMPRESSED SECTIONS WERE FOUND. NO OTHER DAMAGES WERE NOTED IN THE DEVICE. THE ID OF THE MICROCATHETER WAS MEASURED AND WAS WITHIN SPECIFICATION. HUB WAS INSPECTED UNDER MICROSCOPE AND NO DAMAGES WERE NOTED. DISTAL SHAFT WAS INSPECTED UNDER MICROSCOPE NO OTHER DAMAGES THAN THE COMPRESSED AND FLATTENED SECTION WAS NOTED. MICROCATHETER WAS FLUSHED USING A LAB SAMPLE SYRINGE, AFTER FLUSHING A 0.018" CORDIS GUIDEWIRE WAS INSERTED AND IT ADVANCED SMOOTHLY THROUGH THE INNER LUMEN BUT IT WAS STUCK AT 146CM WHERE THE FLATTENED SECTION WAS LOCATED. 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. REVIEW OF LOT 15191708 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. REPORTED FAILURE AS "RESISTANCE IN THE INNER LUMEN" AND SECOND FAILURE REPORTED AS "DISTAL TIP DAMAGES" WERE CONFIRMED. THE CAUSE OF THE RESISTANCE WAS THE FLATTENED SECTIONS NOTED IN THE DISTAL SHAFT. THE CAUSE OF THE COMPRESSED AND FLATTENED SECTIONS NOTED IN THE DEVICE COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER THESE DO NOT APPEARS TO BE MANUFACTURING RELATED DUE TO PER (B)(4) INVESTIGATION THE CUSTOMER STATE THAT "WERE ANY DAMAGES NOTICED WITH THE MICROCATHETER AFTER RE-SHAPING WAS COMPLETED?---NO" WHICH INDICATES THAT THERE WERE NO DAMAGES WHEN THE DEVICE WAS REMOVED FROM THE PACKAGE. IN ADDITION INSPECTIONS ARE IN PLACE THAT PREVENTS THESE KINDS OF DAMAGES LEAVING FROM THE FACILITY. PROCEDURAL AND HANDLING FACTORS APPEAR TO BE CONTRIBUTED IN THE FAILURES EXPERIENCED BY THE CUSTOMER; THEREFORE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS THE FIRST OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2011-00067 AND 1058196-2011-00068. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    THIS IS THE FIRST OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2011-00067 AND 1058196-2011-00068. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    THIS IS THE FIRST OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2011-00067 AND 1058196-2011-00068. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON 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. REVIEW OF LOT 15191708 NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. 12 UNITS WERE REJECTED DURING THE FINAL ASSEMBLY OF THIS LOT. THE DHR REVIEW CONFIRMED THAT THE REJECTED UNITS WERE PROPERLY SEGREGATED AND DISCARDED. NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. THE DHR REVIEW INDICATES THAT THE PRODUCT WAS TESTED AND INSPECTED PER ESTABLISHED MANUFACTURING REQUIREMENTS INCLUDING INSPECTION RESULTS. THIS IS THE FIRST OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2011-00067 AND 1058196-2011-00068. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    DURING A COIL EMBOLIZATION PROCEDURE OF THE RIGHT PCOM WITH A WIDE NECK ASSISTED WITH AN ENTERPRISE STENT, THE PHYSICIAN IMPLANTED THE STENT TO THE TARGET AND RELEASED THE STENT, BUT THE POSITION WAS MOVED, THEN THE PHYSICIAN WANTED TO ADJUST THE POSITION AND WITHDREW THE STENT, BUT HE FOUND IT CANNOT BE WITHDRAWN. THEREFORE, THE ENTERPRISE STENT AND MICROCATHETER WERE REMOVED AS UNIT. AFTER REMOVAL, THE MICROCATHETER TIP WAS NOT SMOOTH, AND IT FELT ROUGH. OTHER DEVICES WERE UTILIZED TO COMPLETE THE PROCEDURE, AND THERE WAS NO IMPACT TO THE PATIENT. DURING DETACHMENT OF THE STENT, THE ENTERPRISE STENT WAS NOT ADVANCE PAST THE DISTAL END OF THE MICROCATHETER, INSTEAD A LITTLE PAST, AND THE STENT WAS NOT EXPOSED PAST THE RECAPTURE POINT. A LITTLER RESISTANCE WAS NOTED DURING THE RECAPTURING OF THE ENTERPRISE STENT, BUT NO ADDITIONAL FORCE WAS UTILIZED IN AN ATTEMPT TO RECAPTURE THE STENT. AFTER THE DEVICES WERE REMOVED, THE ENTERPRISE STENT (STRUT UPLIFT, FRACTURE, KINK, BEND, OR SEPARATED), DELIVERY SYSTEM (KINK, BEND, FRACTURE, SEPARATED, ETC), DISTAL TIP (KINK, BEND, FRACTURE, SEPARATED, UNRAVELED, STRETCHED, ETC), OR MICROCATHETER SHAFT/HUB WAS NOT DAMAGED. THE MICROCATHETER DISTAL TIP WAS NOT RE-SHAPED. THE ADMITTING DIAGNOSES WAS HIGH BLOOD PRESSURE FOR MANY YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROWLER SELECT MICROCATHETERS CES MICROCATHETERS (KRA) KRA CORDIS NEUROVASCULAR, INC. NA 15191708

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male ENTERPRISE| ENTERPRISE