BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELIEVA VORTEX SINUS IRRIGATION CATHETER

    MDR report key: 1662697 · Received April 12, 2010

    Report

    Report Number
    3005172759-2010-00004
    Event Type
    Injury
    Date Received
    April 12, 2010
    Date of Event
    March 10, 2010
    Report Date
    April 8, 2010
    Manufacturer
    ACCLARENT, INC.
    Product Code
    KAM
    PMA / PMN Number
    K062458
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFO PROVIDED, IT IS UNCLEAR THAT ACCLARENT PRODUCT CONTRIBUTED IN ANYWAY TO THE PT EYE SWELLING. 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'S CONDITIONS, ETC... AS OF 4/07/2010, THE ATTEMPT TO CONTACT THE PHYSICIAN HAS BEEN UNSUCCESSFUL. ACCLARENT'S ENT CONSULTANT CONFIRMED THAT THE INTRAOPERATIVE EYE SWELLING OCCURRED AFTER LAVAGING WITH SALINE, AND THAT THE PT HAD A PRE-EXISTING ANATOMICAL DEFECT NOTED ON THE CT SCAN THAT IS BELIEVED TO HAVE CONTRIBUTED TO THE EVENT. THE ENT CONSULTANT ALSO INDICATED THAT THE PHYSICIAN HAD NOTED THE ISSUE WAS NOT A DEVICE PROBLEM. (B) (4). ACCLARENT'S FLEXIBLE BALLOON CATHETERS ARE SPECIFICALLY DESIGNED TO BE ATRAUMATIC, AND NOT DAMAGE TISSUE, OR CAUSE SWELLING. THERE WAS NO INFO IN THE COMPLAINT THAT SUGGESTS ANY ACCLARENT DEVICE FAILURE. NO DEVICE(S) WERE AVAILABLE FOR RETURN. A LOT HISTORY RECORD REVIEW WAS PERFORMED ON LOT# 091117B-CM. THE LOT MET SPECIFICATION. ACCLARENT WIL CONTINUE TO UPDATE THE FILE WITH ANY ADD'L INFO 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 (B) (4) 2010. AFTER BALLOONING A (B) (4) MALE PT'S SINUS WITH A 7X16 SOLO PRO DEVICE, THE PHYSICIAN LAVAGED THE RIGHT FRONTAL SINUS WITH A VORTEX SINUS IRRIGATION CATHETER. DUE TO A PRE-EXISTING RIGHT ORBITAL ANATOMICAL DEFECT CONFIRMED ON THE CT SCAN, THE PT PRESENTED SWELLING OF THE RIGHT EYE. THE PT WAS TREATED BY MAKING A SMALL INCISION NEAR THE EYELID, TO RELIEVE PRESSURE. THE SWELLING WAS NOTED TO SUBSIDE. THE PT DID NOT REQUIRE HOSPITALIZATION. NO PT INJURY OR POST PROCEDURE COMPLAINTS WERE NOTED AS OF 04/08/2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RELIEVA VORTEX SINUS IRRIGATION CATHETER VORTEX KAM ACCLARENT, INC. 091117B-CM

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention