BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCENTRIC RETRIEVER L6

    MDR report key: 950678 · Received April 11, 2007

    Report

    Report Number
    2954917-2007-00006
    Event Type
    Malfunction
    Date Received
    April 11, 2007
    Report Date
    April 11, 2007
    Manufacturer
    CONCENTRIC MEDICAL, INC.
    Product Code
    DQY
    PMA / PMN Number
    K051838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ON THE RETURNED DEVICE SHOWED THAT THE L6 RETRIEVER CORE WIRE FRACTURED IN THE MIDDLE OF THE HELIX, ABOUT 3 LOOPS DISTAL TO THE HELIX PROXIMAL END. BASED ON THE DEVICE INVESTIGATION AND THE INFO PROVIDED, THE SPECIFIC CAUSE OF THE FRACTURE COULD NOT BE DETERMINED. SINCE THE FRACTURED TIP WAS NOT SEEN IN VIVO UNDER FLUOROSCOPY, IT APPEARS TO BE POSSIBLE THAT THE DEVICE FRACTURED DURING WITHDRAWAL THROUGH THE ROTATING HEMOSTATIC VALVE (RHV) ATTACHED TO THE GUIDE CATHETER. THERE IS NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS USED IMPROPERLY OR DID NOT MEET SPECIFICATIONS BEFORE DISTRIBUTION. IN ADDITION, THE MANUFACTURING RECORDS FOR RETRIEVER L6 DEVICE, LOT NUMBER, 32690, WERE REVIEWED AND NO ANOMALIES WERE FOUND THAT ARE RELATED TO THIS COMPLAINT.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS TREATING A PT WHO PRESENTED WITH NEUROVASCULAR OCCLUSION. THE PHYSICIAN PLACED THE 8F BALLOON GUIDE CATHETER AND MADE A FIRST RETRIEVAL ATTEMPT WITH A NEW RETRIEVER L6 AND WAS ABLE TO RETRIEVE SOME CLOT. THE PHYSICIAN MADE A SECOND RETRIEVAL ATTEMPT WITH A SECOND RETRIEVER L6 BUT NO CLOT WAS RETRIEVED. THE PHYSICIAN MADE A THIRD RETRIEVAL ATTEMPT USING A NEW BALLOON GUIDE CATHETER AND A THIRD RETRIEVER L6. WHEN THE THIRD RETRIEVER L6 WAS REMOVED FROM THE PT, IT WAS NOTED THAT THE DISTAL END OF THE SECOND RETRIEVER L6 (WHICH HAD APPARENTLY FRACTURED AT SOME POINT) WAS ATTACHED TO THE HELIX OF THE THIRD RETRIEVER L6. IT WAS CONCLUDED THAT THE SECOND RETRIEVER L6 DISTAL END HAD FRACTURED AND DETACHED DURING THE SECOND RETRIEVAL ATTEMPT. THE PHYSICIAN NOTED THAT THE TIP OF THE SECOND RETRIEVER L6 WAS NOT VISUALIZED UNDER FLUOROSCOPY EITHER AFTER THE SECOND RETRIEVAL ATTEMPT OR DURING THE THIRD RETRIEVAL ATTEMPT. THE PHYSICIAN ONLY REALIZED WHAT HAD HAPPENED AFTER CLOSER EXAMINATION OF THE SECOND AND THIRD RETRIEVERS. TWO MORE RETRIEVAL ATTEMPTS WERE PERFORMED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONCENTRIC RETRIEVER L6 CATHETER, THROMBUS RETRIEVER DQY CONCENTRIC MEDICAL, INC. 90039 32690

    Patients

    Seq Age Sex Outcome Treatment
    1 *