BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASSO® 2515 NAV ECO VARIABLE CATHETER

    MDR report key: 4143569 · Received October 6, 2014

    Report

    Report Number
    9673241-2014-00382
    Event Type
    Injury
    Date Received
    October 6, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 10, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    DRF
    PMA / PMN Number
    K113213
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS DISCARDED, THEREFORE NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. AS LOT # 17002544L WAS PROVIDED, THE DEVICE HISTORY RECORD WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. CONCOMITANT PRODUCTS USED: PRODUCT NAME: JJKK CARTO 3 SYSTEM, US CATALOG #: FG540000J, SERIAL #: (B)(4). PRODUCT NAME: SMART TOUCH BIDIRECTIONAL, US CATALOG #: D132705, LOT #: 17013818M. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT, UNDERWENT A PROCEDURE ON LEFT ATRIUM WITH A LASSO® 2515 NAV ECO VARIABLE CATHETER AND SUFFERED A CARDIAC TAMPONADE WHICH REQUIRED PERICARDIAL DRAINAGE. THE PATIENT¿S MEDICAL HISTORY IS UNKNOWN. THERE IS NO FURTHER INFORMATION ABOUT HOSPITALIZATION. THE PROCEDURE WAS ABORTED. THE PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THIS ADVERSE EVENT IS THAT THIS MIGHT HAVE OCCURRED DUE TO SCRATCHING THE CARDIAC MUSCLE BY THE LASSO 2515 NAV ECO CATHETER. PER 21 CFR, PART 803, THIS COMPLAINT IS REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623349 LASSO® 2515 NAV ECO VARIABLE CATHETER CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER, INC. (JUAREZ) D-1343-02-S 17002544L

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R