BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVISTAR THERMO-COOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER

    MDR report key: 1842938 · Received September 23, 2010

    Report

    Report Number
    9673241-2010-00071
    Event Type
    Injury
    Date Received
    September 23, 2010
    Date of Event
    August 24, 2010
    Report Date
    August 25, 2010
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    OAD
    PMA / PMN Number
    P030031
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE DEVICE WAS NOT RETURNED TO BIOSENSE WEBSTER FOR EVALUATION. OTHER BIOSENSE WEBSTER PRODUCTS USED IN THE PROCEDURE: HALO CATHETER, US CATALOG # D7T20P15RT, LOT # 15147782. NAVISTAR THERMOCOOL TC CATHETER, US CATALOG # NI75TCFH, LOT # 15135903. CARTO 3 SYSTEM, US CATALOG # FG540000, (B)(4). C3 NAV VARIABLE LASSO, US CATALOG # LN222515CT, LOT # 15127322. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING MAPPING FOR AN A-FIB CASE, WHILE MAPPING IN THE LEFT ATRIUM, THE MAPPING WAS 75% COMPLETE WHEN THE PHYSICIAN SWITCHED FROM LASSO NAV TO NAVISTAR THERMOCOOL TO COMPLETE MAPPING. WHEN THE FAM (FAST ANATOMICAL MAPPING) WAS SWITCHED OVER TO NAVISTAR, THE CARTO 3 SYSTEM DEFAULTED TO GATED MODE (MULTIPLE POINTS COULD NO LONGER BE ACQUIRED, AND EACH POINT HAD TO BE INDIVIDUALLY ACQUIRED). AS MAPPING WAS 95% COMPLETE, THE PHYSICIAN DID NOT WANT TO RE-MAP AND RESTART FAM, SO THEY CARRIED ON WITH THE PROCEDURE IN GATED MODE. EVERYTHING WAS NORMAL WITH GEOMETRY AND CATHETER VISUALIZATION. THE CASE CONTINUED AND THE PHYSICIAN COULDN'T MANIPULATE THE CATHETER TO GO ANTERIOR. AT FIRST THEY THOUGHT IT WAS AN ISSUE WITH CATHETER VISUALIZATION ON CARTO, BUT THE PHYSICIAN COULD NOT REACH THE POSITION NEEDED USING FLUOROSCOPY EITHER. THE PHYSICIAN SWITCHED TO A DIFFERENT CURVE CATHETER TO GET A BETTER REACH. AT THIS POINT HE WONDERED IF THE PATIENT HAD SOME DIFFERENT ANATOMY, AND ORDERED A TOE PROBE. THE TOE SHOWED THAT THE PATIENT HAD A TAMPONADE SO, THE PERICARDIUM WAS DRAINED, AFTER WHICH THE PATIENT SEEMED STABLE SO, A RIGHT-SIDED FLUTTER LINE WAS COMPLETED AS PREVIOUSLY PLANNED. THE LEFT-SIDED PROCEDURE WAS ABANDONED AND PATIENT WAS SENT TO ITU. THE PATIENT WAS OK POST-PROCEDURE. THE PHYSICIAN BELIEVED HE HAD ACCIDENTALLY GONE THROUGH AT THE TRANS-SEPTAL PUNCTURE SITE AND THE REASON HE COULD NOT GET ANTERIOR WITH THE CATHETER WAS BECAUSE HE WAS ACTUALLY EPICARDIAL WITH THE MAPPING CATHETER. THE PHYSICIAN DID NOT THINK THE TAMPONADE WAS LINKED TO THE CARTO 3 ISSUE OR TO ANY CATHETER. HE BELIEVES IT WAS A TRANS-SEPTAL PUNCTURE PLACEMENT ISSUE. THE PHYSICIAN DID A SUBSEQUENT VT CASE WITH THE SAME CARTO 3 SYSTEM USING FAM FUNCTION AND NAVISTAR, AND THERE WERE NO ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVISTAR THERMO-COOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER, INC. (JUAREZ) D-1197-16-S 15145423

    Patients

    Seq Age Sex Outcome Treatment
    1 Other