BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASSO DEFLECTABLE CIRCULAR MAPPING

    MDR report key: 2132082 · Received June 16, 2011

    Report

    Report Number
    9673241-2011-00065
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 19, 2011
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    DRF
    PMA / PMN Number
    K002333
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6), 2012, BWI WAS MADE AWARE THAT THE REPORTED BWI SPONSORED CLINICAL TRIAL (CLARITY STUDY) ADVERSE EVENT (PSEUDO ANEURYSM) WAS DETERMINED TO BE CAUSED DURING CATHETERIZATION BY ONE OF THE ABLATION CATHETER DEVICES USED. EVENT WAS CLASSIFIED AS ANTICIPATED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    UPDATED INFORMATION HAS BEEN PROVIDED REGARDING THIS EVENT THAT OCCURRED DURING CLINICAL STUDY. ON (B)(6), 2011, BWI WAS MADE AWARE THAT THIS SUBJECT WHO VISITED THE HOSPITAL ON (B)(6), 2011 THAT THE HEMATOMA IS STILL ONGOING ON THE MEDIAL FEMUR. ALSO ON (B)(6), 2011, BWI WAS NOTIFIED BY THE SITE, THAT THE DESCRIPTION OF THE ADVERSE EVENT HAS BEEN MODIFIED FROM 'OTHER, BLEEDING PUNCTURE SITE' TO 'VASCULAR ACCESS COMPLICATIONS'. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BWI SPONSORED CLINICAL TRIAL (B)(4), THE PATIENT ENCOUNTERED CLINICALLY SIGNIFICANT BLEEDING AT THE INGUINAL REGION OF THE PUNCTURE SITE. ECHOCARDIOGRAPHY SHOWED ANEURYSMA SPURIUM. THE PATIENT WAS TREATED WITH 3 UNITS OF BLOOD TRANSFUSION. EVENT WAS CATEGORIZED AS ANTICIPATED; POSSIBLY DEVICE RELATED; POSSIBLY DRUG RELATED; DEFINITELY PROCEDURE RELATED. PROGNOSIS FOR THE PATIENT IS SATISFACTORY. THE A-FIB PROCEDURE WAS PERFORMED ON (B)(6) 2011. HOWEVER, IT WAS NOT CLASSIFIED AS POSSIBLY DEVICE RELATED UNTIL (B)(6), 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LASSO DEFLECTABLE CIRCULAR MAPPING CATHETER, ELECTRODE RECORDING DRF BIOSENSE WEBSTER, INC. (JUAREZ) D-1220-39-S 15280659L

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R