BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONE

    MDR report key: 1637374 · Received March 20, 2010

    Report

    Report Number
    3005172759-2010-00003
    Event Type
    Injury
    Date Received
    March 20, 2010
    Report Date
    March 17, 2010
    Manufacturer
    ACCLARENT, INC.
    Product Code
    KAM
    PMA / PMN Number
    K062458
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, IT IS UNCLEAR THAT ACCLARENT PRODUCT CONTRIBUTED IN ANY WAY TO THE PT EYE INJURY. SEVERAL ATTEMPTS WERE MADE BY THE ACCLARENT'S MEDICAL DIRECTOR TO CONTACT THE PHYSICIAN WITH THE INTENT OF GATHERING RELEVANT DETAILS SUCH AS THE PT'S CONDITION, PT FOLLOW-UP, ANY PRE-EXISTING PT CONDITIONS, ETC ... AS OF 3/16/2010, THE ATTEMPT TO CONTACT THE PHYSICIAN HAS BEEN UNSUCCESSFUL, HOWEVER, ACCLARENT'S MEDICAL DIRECTOR DID SPEAK WITH THE NURSE MANAGER. THE NURSE MANAGER CONFIRMED THAT THE INTRAOPERATIVE EYE SWELLING OCCURRED AFTER LAVAGING WITH A NON-ACCLARENT SYRINGE, AND THAT THE PT HAD A PRE-EXISTING ANATOMICAL DEFECT THOUGHT TO BE SECONDARY TO THE PREVIOUS INFECTION/INFLAMMATION. A REVIEW OF THE HISTORICAL DATA DEMONSTRATES AN OVERALL COMPLAINT RATE OF 0.003% FOR COMPLAINTS RELATED TO SWELLING. ACCLARENT'S FLEXIBLE BALLOON CATHETERS ARE SPECIFICALLY DESIGNED TO BE ATRAUMATIC, AND NOT DAMAGE TISSUE, OR CAUSE SWELLING. THERE WAS NO INFORMATION IN THE COMPLAINT THAT SUGGESTS ANY ACCLARENT DEVICE FAILURE. THE LOT INFORMATION FOR ACCLARENT DEVICES WAS NOT AVAILABLE. IN ADDITION, NO DEVICE(S) WERE AVAILABLE FOR RETURN. ACCLARENT WILL CONTINUE TO UPDATE THE FILE WITH ANY ADDITIONAL INFORMATION AND PROVIDE SUBSEQUENT REPORTS IF REQUIRED.

    Description of Event or Problem · 1

    THIS EVENT OCCURRED IN ONE PT. ACCLARENT WAS MADE AWARE OF THIS EVENT ON 2/18/2010. AFTER BALLOONING A (B) (6) FEMALE PT'S LEFT FRONTAL SINUS WITH A 6X16 SOLO PRO DEVICE, THE PHYSICIAN ATTEMPTED TO LAVAGE THE SINUS WITH A VORTEX SINUS IRRIGATION CATHETER. DUE TO A LARGE AMOUNT OF PRE-EXISTING PUS, THE PHYSICIAN ALSO USED A 30CC SYRINGE (NON-ACCLARENT DEVICE) IN CONJUNCTION WITH THE VORTEX. UPON THE THIRD APPLICATION, THE PT PRESENTED SWELLING OF THE EYES. THE PT WAS TREATED BY MAKING AN INCISION NEAR THE EYELIDS, TO RELIEVE PRESSURE. THE SWELLING WAS NOTED TO SUBSIDE. A SOLO PRO BALLOON CATHETER WAS THEN USED TO TREAT THE RIGHT FRONTAL SINUS. NO IRRIGATION WAS USED AT THAT TIME. THE PT WAS HOSPITALIZED FOR 1 DAY, AND WAS RELEASED. AS OF (B) (6) 2010, THE PT WAS NOTED TO BE DOING MUCH BETTER, BUT HER EYESIGHT WAS NOTED TO NOT BE AS GOOD AS IT WAS PRIOR TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE KAM ACCLARENT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Other