BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASSO® 2515 NAV ECO VARIABLE CATHETER

    MDR report key: 4633137 · Received March 25, 2015

    Report

    Report Number
    9673241-2015-00171
    Event Type
    Injury
    Date Received
    March 25, 2015
    Date of Event
    March 5, 2015
    Report Date
    March 5, 2015
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE WAS RECEIVED FOR ANALYSIS AT THE TIME OF SUBMISSION OF THE INITIAL 3500A. SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. AS LOT #:15485592A WAS PROVIDED, THE DEVICE HISTORY RECORD(S) 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. BWI CONCOMITANT PRODUCTS USED: PRODUCT NAME: CARTO® 3 SYSTEM US CATALOG #: FG540000 SERIAL #: (B)(4). PRODUCT NAME: STOCKERT 70 RF GENERATOR US CATALOG #: S7001 SERIAL #: (B)(4). PRODUCT NAME: COOLFLOW® IRRIGATION PUMP US CATALOG #: CFP002 SERIAL #: (B)(4). PRODUCT NAME: THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER US CATALOG #: D131503 LOT #: UNKNOWN PRODUCT NAME: WEBSTER® DUO-DECAPOLAR ELECTROPHYSIOLOGY CATHETER US CATALOG #: D728260RT LOT #: 17148247M PRODUCT NAME: SOUNDSTAR® 3D DIAGNOSTIC ULTRASOUND CATHETER US CATALOG #: SNDSTR10 LOT #: S1420136 MANUFACTURER'S REFERENCE #: (B)(6)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MALE PATIENT, UNDERWENT AN ATRIAL FIBRILLATION PROCEDURE WITH A LASSO® 2515 NAV ECO VARIABLE CATHETER AND CATHETER GOT STUCK IN THE MITRAL VALVE WHICH REQUIRED SURGICAL INTERVENTION TO BE REMOVED AND REPAIR OF THE MITRAL VALVE. THE PATIENT¿S MEDICAL HISTORY IS UNKNOWN. NO FURTHER INFORMATION IS KNOWN REGARDING THE PATIENT STATUS. THE PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THIS ADVERSE EVENT IS THAT THIS IS DUE TO THE DESIGN OF THE CATHETER. HOWEVER, THERE IS NO REPORTED MALFUNCTION DURING THE USED OF THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200183 LASSO® 2515 NAV ECO VARIABLE CATHETER CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER, INC. (JUAREZ) D-1343-01-S 15485592A

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| L| O