BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROWLER SELECT MICROCATHETERS

    MDR report key: 3233724 · Received July 18, 2013

    Report

    Report Number
    1058196-2013-00192
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    July 1, 2013
    Report Date
    July 1, 2013
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    KRA
    PMA / PMN Number
    K021591
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    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 15819649 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 1

    A NON-STERILE SELECT PLUS 150/5 CM WAS RECEIVED COILED INSIDE OF A PLASTIC BAG IN THE SAME PLASTIC BAG AN ENTERPRISE WAS FOUND WITHOUT STENT AND INTRODUCER. THE STENT OF THE ENTERPRISE DEVICE WAS FOUND IN THE HUB OF THE RECEIVED MICROCATHETER. THE MICROCATHETER WAS INSPECTED AND IT WAS FOUND KINKED. THE DEVICE WAS INSPECTED UNDER MICROSCOPE AND THE DAMAGES FOUND ON THE VISUAL ANALYSIS WERE CONFIRMED (KINKS SECTIONS). THE ID FROM THE MICROCATHETER WAS MEASURED AND WAS FOUND WITHIN SPECIFICATION ACCORDING TO DOCUMENT ES05104 REV 7. THE MICROCATHETER WAS FLUSHED USING A LAB SAMPLE SYRINGE (NIPRO) AND AFTER THAT A 0.018¿ A GUIDE WIRE LAB SAMPLE WAS INTRODUCED INTO THE MICROCATHETER AND IT ADVANCE SMOOTHLY UNTIL THE MICROCATHETER'S DISTAL TIP; RESISTANCE/FRICTION WAS FELT WHEN THE GUIDE WIRE WAS PASS THROUGH OF THE KINKS SECTIONS FOUND ON THE MICROCATHETER. AFTER THAT THE MICROCATHETER WAS FLUSHED AGAIN AND A LAB SAMPLE ENTERPRISE WAS INTRODUCED INTO THE MICROCATHETER AND IT ADVANCE SMOOTHLY UNTIL THE MICROCATHETER'S DISTAL TIP; RESISTANCE/FRICTION WAS FELT WHEN THE ENTERPRISE WAS PASS THROUGH OF THE KINKS SECTIONS FOUND ON THE MICROCATHETER. 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 FAILURE AS ¿CATHETER - RESISTANCE/FRICTION-INNER LUMEN¿ WAS CONFIRMED DURING THE FUNCTIONAL TEST. THE CAUSE OF THE FAILURE EXPERIENCED BY THE COSTUMER APPEARS WAS DUE TO THE KINKS SECTIONS FOUND ON THE RETURNED DEVICE. THE DAMAGE FOUND ON THE DEVICE COULD NOT BE CONCLUSIVELY DETERMINED. NEITHER THE ANALYSIS NOR THE DHR SUGGEST THAT THE FAILURE REPORTED COULD NOT BE RELATED TO THE MANUFACTURING PROCESS; ADDITIONALLY INSPECTIONS ARE IN PLACE THAT PREVENTS THESE KINDS OF DAMAGES LEAVING FROM THE FACILITY. THEREFORE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. (B)(4).

    Additional Manufacturer Narrative · 1

    DURING THE PROCEDURE, THE PHYSICIAN WANTED TO REMOVE THE ENTERPRISE VRD (ENF452212/10210277) FROM PATIENT BECAUSE THE DEVICE WAS NOT SUITABLE, BUT THE ENTERPRISE WAS STUCK IN THE PROXIMAL HUB OF PROWLER MICROCATHETER (606S255X/15819649). THEREFORE, ANOTHER ENTERPRISE WAS USED AND THE PROCEDURE WAS SUCCESSFULLY DONE. THERE WAS NO ADVERSE EVENT REPORTED AND THE DEVICES WILL BE RETURNED FOR ANALYSES. ONE NON-STERILE ENTERPRISE WAS RECEIVED COILED IN A PLASTIC BAG. THE UNIT WAS VISUALLY INSPECTED AND NO ANOMALIES WERE FOUND. STENT WAS FOUND ON MICROCATHETER HUB. NOTE: ONLY DELIVERY WIRE AND STENT WERE RECEIVED FROM ENTERPRISE CATHETER. ALSO A MICROCATHETER PROWLER SELECT PLUS (UNIT INVOLVED IN COMPLAINT, RECEIVED UNDER (B)(4)) WAS ALSO RECEIVED. MULTIPLE KINKS AND BENTS WERE FOUND ALONG THE MICROCATHETER BODY. COIL TIP AND STENT WERE OBSERVED UNDER MICROSCOPE MAGNIFICATION AND NO DAMAGES/ANOMALIES WERE FOUND. FUNCTIONAL TEST WAS PERFORMED WITH INVOLVED MICROCATHETER (RECEIVED UNDER (B)(4)) AND FRICTION WAS FELT WHILE ADVANCING ENTERPRISE THROUGH DAMAGED SECTION OF THE BODY. NOTE: THIS TEST WAS PERFORMED WITHOUT STENT; ALSO SINCE INTRODUCER TUBE WAS NOT RECEIVED AN INTRODUCER LAB SAMPLE WAS USED ON THIS TEST. LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 10210277. 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 FAILURE REPORTED BY THE CUSTOMER AS ¿DELIVERY WIRE WITHDRAWAL DIFFICULTY-THROUGH MICROCATHETER¿ WAS CONFIRMED. HOWEVER THIS FAILURE MIGHT BE RELATED TO THE CONDITION OF INVOLVED MICROCATHETER (KINKED AND BENT). ANALYSIS AND DHR REVIEW INDICATES THAT THE DEVICE DID NOT PRESENT ANY OBVIOUS INDICATION OF MANUFACTURING DEFECT OR ANOMALY THAT COULD CONTRIBUTE TO THE EVENT AS REPORTED. THE CAUSE OF THE EVENT EXPERIENCED BY THE CUSTOMER COULD NOT BE CONCLUSIVELY DETERMINED. IT IS POSSIBLE THAT PROCEDURAL FACTORS OR HANDLING MAY HAVE CONTRIBUTED WITH THE REPORTED CONDITION SINCE THE RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATION PRIOR TO SHIPMENT; THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE PHYSICIAN WANTED TO REMOVE ENF FROM PATIENT BECAUSE THE ENF SIZE WAS NOT SUITABLE. BUT THE ENF22 STUCKED IN THE PROXIMAL HUB OF PROWLER CATHETER. HE USED ANOTHER ENF AND THE PROCEDURE WAS SUCCESSFULLY DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333611 PROWLER SELECT MICROCATHETERS CES MICROCATHETERS (KRA) KRA CORDIS NEUROVASCULAR, INC. NA 15819649

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK PROWLER MICROCATHETER