BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIEVA FLEX SINUS GUIDE CATHETER

    MDR report key: 2894337 · Received November 16, 2012

    Report

    Report Number
    3005172759-2012-00036
    Event Type
    Malfunction
    Date Received
    November 16, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 17, 2012
    Manufacturer
    ACCLARENT
    Product Code
    LRC
    PMA / PMN Number
    K043445
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCLARENT FOLLOWED UP ON THIS REPORT TO GATHER ADDITIONAL INFORMATION. THE SURGEON STATED THAT THERE WAS NO PATIENT INJURY AND HE DID NOT NEED TO INTERVENE IN ANY WAY FURTHER BECAUSE OF THE TIP SEPARATION. HE ALSO CONFIRMED THAT THE GUIDE CATHETERS WERE NEW AND NOT REPROCESSED OR USED PREVIOUSLY. (B)(4) CONCLUDED THAT FROM THE INFORMATION PROVIDED THAT THE MOST LIKELY CAUSE FOR THE TIP SEPARATION WAS THAT THE SURGEON INTENTIONALLY DEFORMED AND BENT THE GUIDE CATHETER AS THE CANNULATION WAS DIFFICULT WITH MULTIPLE ATTEMPTS AND USING THE OUT-OF-PACKAGE GUIDE CATHETER. ACCLARENT'S IFU'S WARNINGS AND PRECAUTIONS STATES, "WHEN USING THE FLEX SINUS GUIDE CATHETER, DO NOT ATTEMPT TO BEND THE NON-MALLEABLE SHAFT". THE SUBJECT DEVICE OF THIS REPORT WAS NOT RETURNED FOR EVALUATION, AND ITS WHEREABOUTS ARE UNKNOWN. ACCLARENT WILL CONTINUE TO MONITOR THIS PHENOMENON FOR TRENDING PURPOSES. THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    ACCLARENT WAS NOTIFIED ON (B)(4) 2012 OF AN INTERNATIONAL EVENT THAT OCCURRED ON (B)(6) 2012 DURING A SINUS SURGICAL CASE WHEN ACCLARENT BALLOON DILATION TECHNOLOGY WAS USED. THE SURGEON INDICATED THAT WHEN HE PERFORMED A BILATERAL BALLOON SINUPLASTY PROCEDURE, HE HAD DIFFICULTY INSERTING THE ACCLARENT MAXILLARY SINUS GUIDE CATHETER INTO THE INFUNDIBULUM BECAUSE OF ITS SIZE. AFTER BENDING THE GUIDE TIP SEVERAL TIMES TO GAIN ACCESS TO THE INFUNDIBULUM, HE NOTED THAT THE BLUE TIP OF THE GUIDE CATHETER HAD SEPARATED, NOT DETACHED, FROM THE GUIDE SHAFT. HE THEN USED A FRONTAL SINUS GUIDE CATHETER TO TRY GAIN ACCESS TO THE INFUNDIBULUM AND HE AGAIN INTENTIONALLY BENT THE GUIDE CATHETER SEVERAL TIMES AND NOTED THAT THIS CATHETER'S BLUE TIP ALSO SEPARATED, NOT DETACHED FROM THE SHAFT GUIDE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RELIEVA FLEX SINUS GUIDE CATHETER FLEX GUIDE CATHETER LRC ACCLARENT M-110 120322K-CM

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR