BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER

    MDR report key: 5041707 · Received August 31, 2015

    Report

    Report Number
    2134070-2015-00041
    Event Type
    Injury
    Date Received
    August 31, 2015
    Date of Event
    June 24, 2015
    Report Date
    August 3, 2015
    Manufacturer
    STERILMED, INC.
    Product Code
    OWQ
    PMA / PMN Number
    K110076
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND WAS SUBJECTED TO FULL ELECTRICAL TESTING. THE DEVICE FAILED ITS ACOUSTIC VERIFICATION TESTING. RECORDS SHOW THAT THE DEVICE PASSED THIS AND ALL TESTS PRIOR TO BEING SENT TO THE ACCOUNT. NO CONCLUSION COULD BE MADE AS TO THE ROOT CAUSE OF THIS FAILURE AS THE DEVICE WAS NOTED TO BE USED DURING THE PROCEDURE. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER AS OF THE DATE OF THIS REPORT. A SUPPLEMENTAL REPORT WILL BE SENT AFTER DEVICE EVALUATION IF THE DEVICE IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN AFIB CASE, A PERFORATION WAS NOTICED WHEN THE PATIENT'S BLOOD PRESSURE DROPPED AND CONFIRMED THROUGH AN ULTRASOUND. IT WAS REPORTED THAT THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS AND 1680CC OF FLUID WAS REMOVED AND THEN THE PATIENT WAS MOVED TO THE OR FOR SURGICAL INTERVENTION TO FIX THE PERFORATION. THE PATIENT WAS REPORTED TO BE STABLE WHEN HE LEFT THE EP LAB. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF THE ADVERSE EVENT. EVENT OCCURRED DURING ABLATION. OVERALL ABLATION TIME AT THE SITE OF INJURY WAS 40 SECONDS. THE LAST ABLATION CYCLE TIME WAS 10 SECONDS. NOTED SETTINGS USED AT THE TIME OF INJURY ARE POWER MODE-TEMP WARNING 37 AND CUT OFF 40, IMP CUT OFF 250 INJURY NOTED TEMP 28-29*C, POWER 30W, IMP 250.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575440 REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER OWQ STERILMED, INC. BIOSNDSTR10

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention