BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION

    MDR report key: 3773321 · Received April 25, 2014

    Report

    Report Number
    2029046-2014-00124
    Event Type
    Injury
    Date Received
    April 25, 2014
    Date of Event
    April 1, 2013
    Report Date
    April 14, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    LPB
    PMA / PMN Number
    P990025/S9
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD REVIEW COULD BE PERFORMED. CONCOMITANT BWI PRODUCTS: PRODUCT: CARTO® 3 SYSTEM, US CATALOG # FG540000, SERIAL # UNKNOWN; PRODUCT: LASSO®, US CATALOG # UNKNOWN, LOT # UNKNOWN. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN DISPOSED BY THE CUSTOMER. ON APRIL 29TH, 2014 RECEIVED ADDITIONAL INFORMATION FROM BWI REPRESENTATIVE STATING THAT AFTER A CALL WITH THE HOSPITAL, IT WAS CONFIRMED THAT THE EVENT OCCURRED BETWEEN (B)(6) 2011 AND (B)(6) 2012. THE EVENT WAS NOT DEVICE RELATED, THAT IS THE REASON AS TO WHY THE PHARMACIST DID NOT INFORMED OF THIS EVENT AT THAT TIME. THE PHARMACIST ALSO ASSURED THAT IF THE DEVICE HAD ANY IMPLICATION OR RELATIONSHIP TO THE EVENT, THEY WOULD HAVE WARNED US AND LET US KNOW OF THIS. NO FURTHER INFORMATION WILL BE AVAILABLE FOR THIS CASE. PER THE INFORMATION RECEIVED, THE EVENT DATE HAS BEEN UPDATED FROM (B)(6) 2013 TO (B)(6) 2012.

    Description of Event or Problem · 1

    THE BELOW EVENT REPORTED INVOLVED A BWI PRODUCT (NAVISTAR RMT) WAS DESCRIBED IN THE SCIENTIFIC LITERATURE JOURNAL: ARCHIVES OF CARDIOVASCULAR DISEASE (2014) 107, 88¿95, PUBLISHED ON FEBRUARY 18TH, 2014. ALL INFORMATION HAS BEEN RECEIVED BY BIOSENSE WEBSTER QUALITY DEPARTMENT ON (B)(4) 2014. "FIVE HOURS AFTER THE PROCEDURE, A (B)(6) WOMAN WITH A PFO PRESENTED A CEREBRAL HEMORRHAGE REQUIRING NEURO-SURGICAL EMERGENCY REVISION. THE POSTOPERATIVE PERIOD WAS UNFORTUNATELY COMPLICATED BY A DEFINITIVE RIGHT HEMIPLEGIC PROCEDURE-RELATED DEFICIT. NO TAMPONADE WAS OBSERVED AND NO CHAR ON THE CATHETER TIP WAS NOTICED UPON CATHETER REMOVAL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251699 ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION LPB BIOSENSE WEBSTER, INC (IRWINDALE) NAVISTAR RMT UNKNOWN_NAVISTAR RMT

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening