BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASSO¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 2970238 · Received February 20, 2013

    Report

    Report Number
    2029046-2013-00022
    Event Type
    Injury
    Date Received
    February 20, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 7, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    DRF
    PMA / PMN Number
    K002333
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD REVIEW COULD BE PERFORMED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE END OF AN AFIB ABLATION PROCEDURE AS THE PHYSICIAN WAS PULLING THE LASSO CATHETER AND THE SHEATH OUT FROM THE LEFT ATRIUM, HE FELT SOMETHING WAS SCRATCHING. IT WAS DISCOVERED THAT THE TIP OF THE LASSO CATHETER WAS PROJECTING FROM THE SHEATH. AFTER A WHILE, THE PATIENT BLOOD PRESSURE DROP WAS OBSERVED. PERICARDIAL EFFUSION WAS CONFIRMED USING ULTRASOUND. DRAINAGE WAS IMMEDIATELY PERFORMED. THEN THE BLOOD PRESSURE RECOVERED. THE NORMAL MOVEMENTS OF ATRIUMS WERE CONFIRMED BY THE ULTRASOUND FINDINGS. FOLLOWING THE PROCEDURE, THE PATIENT CONDITION WAS STABLE. NO OTHER PARTICULAR INFORMATION WAS REPORTED AFTER THAT. A LONG SHEATH WAS USED WITH THE ABLATION CATHETER IN THE PROCEDURE, HOWEVER THE DETAIL OF THE SHEATH WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73925 LASSO¿ ELECTROPHYSIOLOGY CATHETER CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER, INC (IRWINDALE) D-1220-39-S UNKNOWN_D-1220-39-S

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R