BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELIEVA VIGOR GUIDEWIRE

    MDR report key: 1578118 · Received January 9, 2010

    Report

    Report Number
    3005172759-2010-00001
    Event Type
    Injury
    Date Received
    January 9, 2010
    Date of Event
    December 10, 2009
    Report Date
    January 8, 2010
    Manufacturer
    ACCLARENT, INC.
    Product Code
    KAM
    PMA / PMN Number
    K062458
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, IT IS UNCLEAR WHICH ACCLARENT INSTRUMENTS, IF ANY, MAY HAVE CONTRIBUTED TO THE CSF LEAK. MULTIPLE ATTEMPTS FROM ACCLARENT'S MEDICAL DIRECTOR HAVE BEEN MADE TO CONTACT THE PHYSICIAN, BUT HAVE BEEN UNSUCCESSFUL TO DATE. BASED ON THE INFORMATION PROVIDED BY THE ENT CONSULTANT, NO DEVICE MALFUNCTION WAS NOTED TO HAVE OCCURRED. ACCLARENT HAS SEEN OTHER CASES IN WHICH SIMILAR INJURY WAS DUE TO A CONGENITAL OR PREVIOUSLY ACQUIRED DEHISCENCE. THE LOT INFORMATION WAS NOT AVAILABLE. IN ADDITION, THE DEVICES WERE NOT AVAILABLE FOR RETURN. A REVIEW OF THE HISTORICAL TRENDING WAS PERFORMED.

    Description of Event or Problem · 1

    THIS EVENT OCCURRED IN ONE PATIENT. ACCLARENT WAS MADE AWARE OF THIS EVENT ON 12/11/2009. THE FOLLOWING INFORMATION BELOW WAS PROVIDED FROM THE ENT CONSULTANT PRESENT AT THE CASE, AND HAS BEEN REVIEWED BY ACCLARENT'S MEDICAL DIRECTOR. THE PATIENT HAD ENDOSCOPIC SINUS SURGERY INCLUDING THE USE OF BALLOON CATHETERS IN ALL SINUSES, VORTEX IRRIGATION, AND THE PLACEMENT OF STRATUS DEVICES IN THE LEFT FRONTAL AND BILATERAL ETHMOID SINUSES. FROM THE AP VIEW, THE ENT CONSULTANT NOTED THAT THE WIRE WENT BEYOND THE FRONTAL SINUS, INTO WHAT APPEARED THE BRAIN. THE PHYSICIAN STOPPED, REMOVED THE WIRE, AND ATTEMPTED TO PLACE IT A SECOND TIME. UPON THE SECOND ATTEMPT, THE WIRE WAS NOTED TO TRAVEL IN THE SAME INCORRECT DIRECTION. THE STRATUS DEVICE WAS NOT PLACED IN THE RIGHT FRONTAL SINUS AFTER DUE TO THIS DIFFICULTY WITH GUIDEWIRE PLACEMENT. THE CASE WAS FINISHED AT 8:30PM. DUE TO THE LATE HOUR, THE PATIENT STAYED OVERNIGHT AT THE HOSPITAL. THE FOLLOWING MORNING, THE PATIENT WAS NOTED TO FEEL FINE, HOWEVER, A MINOR CSF LEAK WAS NOTED. A SCAN WAS PERFORMED, AND A SMALL ANATOMICAL LESION WAS NOTED. THE PHYSICIAN ASKED THE PATIENT IF HE HAD EVER HAD ANY PRIOR SKULL FRACTURE. THE PATIENT STATED THAT HE DID IN FACT HAVE A FOOTBALL INJURY. THE PATIENT WAS ABLE TO RECOVER FROM THE CSF LEAK WITHOUT ANY ADDITIONAL MEDICAL OR SURGICAL INTERVENTION NEEDED AFTER THE INITIAL OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RELIEVA VIGOR GUIDEWIRE VIGOR KAM ACCLARENT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| O