BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROWLER SELECT MICROCATHETERS

    MDR report key: 3120506 · Received May 20, 2013

    Report

    Report Number
    1058196-2013-00141
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 25, 2013
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    KRA
    PMA / PMN Number
    K021591
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE INFORMATION: THE PROVIDED LOT # 15737603 HAS NOT BEEN ADDED TO THE SYSTEM YET AND WAS THEREFORE ENTERED IN AS UNK. THE PRODUCT WILL BE RETURNED FOR ANALYSIS, HOWEVER IT HAS NOT BEEN RECEIVED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: ENTERPRISE VRD AND DELIVERY (ENC452212/10149724); NEW STENT (DETAILS UNKNOWN); NEW MICROCATHETER (DETAILS UNKNOWN).

    Additional Manufacturer Narrative · 1

    WHEN THE ENTERPRISE VRD (ENC452212/10149724) WAS POSITIONED AT THE TARGET AND THE PHYSICIAN PLANNED TO RELEASE IT, IT WAS DIFFICULT TO WITHDRAW THE PROWLER SELECT PLUS 150/5 MICROCATHETER (606S255X/UNK) TO RELEASE THE STENT. IT WAS ALSO DIFFICULT TO ADVANCE THE MICROCATHETER (MC). RESISTANCE WAS NOTED BETWEEN THE MC AND THE STENT. THE STENT AND MC WERE WITHDRAWN AS A UNIT, BUT THE STENT WAS RELEASED OUTSIDE OF THE PATIENT. BOTH THE MC AND STENT WERE CHANGED TO COMPLETE THE PROCEDURE. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MC. THE MC WAS NOT RE-SHAPED. THERE WERE NO DAMAGES NOTED ON THE STENT AND MC PRIOR TO AND AFTER USE. THE MC WAS DISCARDED AND THEREFORE NOT AVAILABLE FOR ANALYSIS. (B)(4) THE LOT NUMBER PROVIDED FOR THE PROWLER SELECT PLUS MC IS NOT A VALID LOT NUMBER CORRESPONDING TO THIS DEVICE. NO FURTHER INFORMATION REGARDING THE LOT NUMBER IS AVAILABLE; THEREFORE A DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED. ADDITIONALLY, WITHOUT THE RETURN OF THE INVOLVED MC FOR ANALYSIS, NO CONCLUSION CAN BE MADE REGARDING THE RELATIONSHIP TO THE REPORTED EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. (B)(4) ONE NON STERILE ENTERPRISE AND DELIVERY WIRE WAS RECEIVED COILED INSIDE A PLASTIC BAG. THE ENTERPRISE STENT WAS RECEIVED DEPLOYED WITHOUT ANY VISUAL DAMAGE. THE DELIVERY WIRE WAS RECEIVED INSERTED INTO THE INTRODUCER TUBE. NO OTHER VISUAL ANOMALIES WERE OBSERVED. THE DELIVERY WIRE AND THE STENT WERE INSPECTED UNDER A MICROSCOPE AND NO ANOMALIES WERE OBSERVED. THE FUNCTIONAL ANALYSIS WAS PERFORM ACCORDING TO PROCEDURE USING A LAB SAMPLE MC SINCE THE MC INVOLVED WAS NOT RETURNED FOR ANALYSIS. THE DELIVERY WIRE WITHOUT STENT WAS ABLE TO GO THROUGH THE MC AND NO RESISTANCE OR FRICTION WAS FELT. LAKE REGION MEDICAL REVIEWED THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 10149724. THE DEVICE HISTORY RECORD REVIEW ALSO INCLUDED A REVIEW OF THE CERTIFICATE OF CONFORMANCE RECEIVED FROM SPECIALTY COATINGS SYSTEMS AND NITINOL DEVICES AND COMPONENTS, ALONG WITH LAKE REGION MEDICAL¿S INTERNAL RECEIVING INSPECTION RECORDS FOR THE STENTS ISSUED TO THE COMPLAINT LOT. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THE REPORTED INABILITY TO DEPLOY THE ENTERPRISE STENT COULD NOT BE FULLY EVALUATED SINCE AS REPORTED WAS DEPLOYED AFTER REMOVAL FROM THE PATIENT. THERE WAS NO RESISTANCE/FRICTION OR DIFFICULTY ADVANCING OR WITHDRAWING THE ENTERPRISE DELIVERY WIRE FROM A LAB SAMPLE SIMILAR MC. ALTHOUGH NO DEFINITIVE CONCLUSION CAN BE MADE, IT IS POSSIBLE THAT PROCEDURAL/CLINICAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. THE EXACT CAUSE OF THE EVENT EXPERIENCED BY THE CUSTOMER COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, WITH REVIEW OF THE ANALYSIS OF THE RETURNED DEVICE AND THE DEVICE HISTORY RECORDS REVIEW, THERE IS NO INDICATION OF ANY RELATIONSHIP TO THE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. THE PROVIDED LOT # 15737603 IS INCORRECT. FOLLOW UP INVESTIGATION HAS BEEN SENT TO OBTAIN THE CORRECT LOT #. ADDITIONAL INFORMATION, IF AVAILABLE, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS EVENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2013-00141 AND 1058196-2013-00142.

    Description of Event or Problem · 1

    WHEN THE ENTERPRISE VRD AND DELIVERY (ENC452212/10149724) WAS POSITIONED AT THE TARGET AND PHYSICIAN PLANNED TO RELEASE IT, HE FOUND IT WAS DIFFICULT TO WITHDRAW THE SELECT PLUS 150/5 CM MICROCATHETER (606S255X/15737603) TO RELEASE THE STENT, AND ALSO DIFFICULT TO ADVANCE THE MICROCATHETER. RESISTANCE WAS NOTED BETWEEN THE MICROCATHETER AND THE STENT. THE STENT AND MICROCATHETER WERE WITHDRAWN AS A UNIT, BUT THE STENT WAS RELEASED OUTSIDE OF THE PATIENT. BOTH THE MICROCATHETER AND STENT WERE CHANGED TO COMPLETE THE PROCEDURE. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THE CATHETER WAS NOT RE-SHAPED. THERE WERE NO DAMAGES NOTED ON THE STENT AND MICROCATHETER PRIOR TO AND AFTER USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221984 PROWLER SELECT MICROCATHETERS CES MICROCATHETERS (KRA) KRA CORDIS NEUROVASCULAR, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1