BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APOLLO SYSTEM APOLLO WAND

    MDR report key: 4182836 · Received October 17, 2014

    Report

    Report Number
    3005168196-2014-00732
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 19, 2014
    Manufacturer
    PENUMBRA, INC.
    Product Code
    GWG
    PMA / PMN Number
    K132931
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: THERE IS NO VISIBLE DAMAGE TO THE EXTERIOR OF THE APOLLO WANDS. CONCLUSION: THE COMPLAINT HAS BEEN EVALUATED. THE COMPLAINT INDICATES THAT THE APOLLO LONG CATHETER LEAKED AT THE CONNECTION THE WAND ATTACHES TO THE IRRIGATION TUBING. EVALUATION OF THE RETURNED DEVICES CONFIRMED THAT THE APOLLO LONG CATHETERS WERE FULLY FUNCTIONAL. BASED ON THE DESCRIPTION OF THE EVENT AND EVALUATION OF THE RETURNED DEVICES, IT APPEARS THAT THE LUER FITTING THAT CONNECTS THE WAND TO THE IRRIGATION TUBING MIGHT HAVE NOT BEEN TIGHTENED PROPERLY WHEN THE SYSTEM WAS CONFIGURED DURING PREPARATION FOR THE PROCEDURE. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2014-00733.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A MICRONEUROSURGERY PROCEDURE USING THE APOLLO SYSTEM APOLLO WAND. DURING THE PROCEDURE, TWO APOLLO WANDS BEGAN TO LEAK AT THE IRRIGATION TUBING CONNECTION. ANOTHER APOLLO WAND WAS USED AND THE PROCEDURE CONTINUED SUCCESSFULLY. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661367 APOLLO SYSTEM APOLLO WAND GWG GWG PENUMBRA, INC. F43966

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR