BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROWLER SELECT MICROCATHETERS

    MDR report key: 1220415 · Received October 31, 2008

    Report

    Report Number
    1058196-2008-00260
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Date of Event
    August 25, 2008
    Report Date
    August 26, 2008
    Manufacturer
    CORDIS NEUROVASCUALR, INC.
    Product Code
    KRA
    PMA / PMN Number
    K021591
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF THREE PRODUCTS USED ON THE SAME PATIENT. MDR REPORT # 1058196-2008-00214 & 1058196-2008-00215 & 1058196-2008-00260. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    INTERFERENCE/STENT REMAIN IN MC. PHYSICIAN PREPPED 28MM ENTERPRISE STENT AS PER IFU, PLACED PROWLER SELECT PLUS DISTAL TO NECK OF LEFT INTERNAL CAROTID ARTERY (ICA) ANEURYSM, PHYSICIAN WAS ATTEMPTING TO POSITION THE ENTERPRISE STENT AND ACCORDING TO THE PHYSICIAN, THE STENT JUMPED FORWARD AND THE STENT DEPLOYED MORE DISTAL, NOT AT THE TARGET SITE. PHYSICIAN FEELS IT MAY HAVE BEEN DUE TO TORTUOSITY OF THE VESSEL AND THE AMOUNT OF TENSION BUILT UP IN THE CATHETER. THE PHYSICIAN WAS THEN ATTEMPTING TO PLACE A SECOND STENT, A 22MM TO COMPENSATE FOR THE MISPLACEMENT AND TO COVER THE NEXT OF THE ANEURYSM, WHILE ADVANCING THE STENT IN THE PROWLER SELECT PLUS, THE PHYSICIAN FELT RESISTANCE AND FICTION, HE ATTEMPTED TO PULL THE STENT BACK INTO THE DELIVERY SHEATH, BUT UPON VISUAL EXAM, THE STATED STENT WAS NOT ON THE DELIVERY WIRE. THE PHYSICIAN REMOVED THE PROWLER SELECT PLUS, AND VISUALIZED UNDER FLUORO, THE STENT WAS PRESENT INSIDE THE MICROCATHETER JUST DISTAL TO THE HUB. THE PHYSICIAN THEN PLACED A NEW PROWLER SELECT PLUS, AND POSITIONED IT ACROSS THE NECK OF THE ANEURYSM; THE PHYSICIAN THEN PLACED ANOTHER 22MM STENT THAT OVER-LAPPED WITH THE 1ST STENT PLACED. SLACK WAS REMOVED FROM THE MC & THE GUIDING CATHETER (GC). THE PHYSICIAN THEN COILED THE ANEURYSM AS PLANNED WITHOUT ANY FURTHER ISSUES. THE PATIENT IS REPORTEDLY DOING FINE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR STENT