BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTARAY® NAV HIGH-DENSITY MAPPING CATHETER

    MDR report key: 3259806 · Received August 1, 2013

    Report

    Report Number
    9673241-2013-00260
    Event Type
    Injury
    Date Received
    August 1, 2013
    Date of Event
    July 4, 2013
    Report Date
    July 9, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    MTD
    PMA / PMN Number
    K120425
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONCOMITANT PRODUCTS: SMART TOUCH BIDIRECTIONAL MODEL # D-1327-05-S, LOT # UNKNOWN (NOT MARKETED IN US). C3 INTERFACE CABLE ¿ THERAPEUTIC MODEL # D-1286-03-S, LOT # UNKNOWN. C3 INTERFACE CABLE ¿ DIAGNOSTIC MODEL # D-1286-01-S, LOT # UNKNOWN. C3 EXTERNAL REFERENCE PATCH MODEL # D-1283-02 LOT # UNKNOWN. CARTO 3 MODEL # M-4800-01, SERIAL # (B)(4). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATRIAL TACHYCARDIA (AT) PROCEDURE, THE CATHETER WAS INSERTED INTO THE HEART FOR MAPPING IN THE RIGHT ATRIUM (RA). AFTER TREATMENT OF THE ATRIAL TACHYCARDIA THE CATHETER (SMART TOUCH, BARD QUADRIPOLAR) WERE REMOVED, WHICH WERE PLACED THROUGH DIRECT FEMORAL SHEATH. THE PENTARAY NAV CATHETER WAS INSERTED VIA A NON STEERABLE SHEATH, WHICH WAS ALSO INSERTED VIA A FEMORAL VEIN INTO THE RA. WHEN THE PENTARAY NAV CATHETER WAS BEING REMOVED, THE SHEATH WAS ALREADY 5CM AWAY FROM THE RA/IVC JUNCTION AND THEREFORE THE PENTARAY NAV CATHETER DESCENDED DOWN 5CM WITH THE SPLINES EXPOSED AND FACING AWAY FROM THE DIRECTION OF TRAVEL, INTO THE SHEATH TO BE REMOVED FROM THE PATIENT. AN INFERIOR VENA CAVA (IVC) DISSECTION WAS REPORTED POST PROCEDURE. THE OUTCOME OF THE ADVERSE EVENT WAS FULLY RECOVERED. THE PHYSICIAN¿S OPINION REGARDING THE CAUSALITY OF ADVERSE EVENT WAS POSSIBLE DEVICE-RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360026 PENTARAY® NAV HIGH-DENSITY MAPPING CATHETER CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD BIOSENSE WEBSTER, INC. (JUAREZ) D-1282-04-S UNKNOWN_D-1282-04-S

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| L| R