BEUDAMED
    FDA Adverse Event Death Summary report: N

    LASSO 2515 NAV VARIABLE CATHETER

    MDR report key: 2759241 · Received September 25, 2012

    Report

    Report Number
    9673241-2012-00265
    Event Type
    Death
    Date Received
    September 25, 2012
    Date of Event
    August 8, 2012
    Report Date
    August 31, 2012
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    DRF
    PMA / PMN Number
    K081258
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR BWI INVESTIGATION. DEVICE HISTORY RECORDS 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: CARTO 3 SYSTEM US CATALOG #: FG540000 SERIAL #: (B)(4); SMART TOUCH BIDIRECTIONAL US CATALOG #: D132705 LOT #: 15628386M; C3 EXTERNAL REFERENCE PATCH US CATALOG #: CREFP6 LOT #: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A PAROXYSMAL A-FIB PROCEDURE ON (B)(6)2012. ON (B)(6) 2012, THE PATIENT WAS ADMITTED AGAIN IN THE HOSPITAL WITH A CLINICAL CONDITION SUSPICIOUS OF ATRIO-ESOPHAGEAL-FISTULA AND THE PATIENT SUDDENLY DIED SHORTLY AFTER. HOWEVER, THERE WAS NO CLINICAL DATA THAT CONFIRMS THIS DIAGNOSTIC. THERE IS NO FURTHER INFORMATION ABOUT THE HOSPITALIZATION AND IF ADDITIONAL INTERVENTION WAS PERFORMED. IT WAS NOT CONFIRMED IF THE PATIENT PASSED AWAY ON (B)(6) 2012. THE PHYSICIAN'S OPINION REGARDING THE CAUSALITY OF THE EVENT IS POSSIBLE PROCEDURE AND DEVICE RELATED. PHYSICIAN SUSPECTED THAT IT COULD BE DUE TO RF APPLICATIONS AT THE POSTERIOR WALL OF THE LEFT ATRIUM. IT CAN BE ALSO RELATED TO PROFOUND SEDATION OF THE PATIENT (THAT INTERFERES WITH ESOPHAGUS MOVEMENT). IN ADDITION, THE PHYSICIAN CONSIDERED THAT IT COULD BE RELATED TO THE STIFFNESS OF THE SMARTTOUCH CATHETER AND THE PHYSICIAN REACTION TO THE FORCE APPLIED. NO AUTOPSY WAS PERFORMED. BWI DECIDED TO REPORT THIS EVENT UNDER LASSO CATHETER SINCE THE SUSPECTED CONTRIBUTOR TO THE AE FISTULA SMARTTOUCH CATHETER HAS NOT BEEN APPROVED BY THE FDA AND IS NOT MARKETED IN THE US YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LASSO 2515 NAV VARIABLE CATHETER ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE DRF BIOSENSE WEBSTER, INC. (JUAREZ) D-1290-01-S 15594810L

    Patients

    Seq Age Sex Outcome Treatment
    1 Death