BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASSO 2515 NAV VARIABLE CATHETER

    MDR report key: 3195792 · Received June 28, 2013

    Report

    Report Number
    9673241-2013-00213
    Event Type
    Malfunction
    Date Received
    June 28, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 13, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    DRF
    PMA / PMN Number
    K081258
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION STILL IN PROGRESS. A SUPPLEMENTAL REPORT OR DEVICE EVALUATION WILL BE SUBMITTED. (B)(4). OPENED UP A NEW LASSO NAVIGATIONAL CATHETER, INSERTED IT IN TO PATIENT, AND UPON CONNECTING IT WITH THE CABLE TO THE PIU THE ARTIFACT STILL APPEARED; TRIED USING DIFFERENT PINS FOR THE PRUKA PIN BOX (IT WAS ORIGINALLY IN PLUGGED INTO PRUKA PIN BOX A, POLES 1-10 SO WE MOVED THIS TO PIN BLOCK A POLES 17-26.) WHEN THAT STILL DID NOT HELP, IT WAS SWITCHED TO THE PRUKA PIN BLOCK B, POLES 1-10; INSPECTED ALL OF THE CONNECTIONS TO SEE IF ANY OF THE PINS WERE BROKEN (ENDS OF THE LASSO CATHETER, THE CABLES, AND ALL OF THE PINS AND PRUKA PIN BOXES). IN (B)(6) THEY CLOSED THE STUDY AND OPENED A NEW STUDY UNDER A DIFFERENT STUDY CONFIGURATION SETTING. ALSO ADJUSTED THE GAINS AND FILTERS. AFTER TRYING EACH OF THESE CHANGES, EVERY TIME THEY RE-PLUGGED IN THE LASSO NAV CABLE TO THE PIU THE ARTIFACT REAPPEARED, COMPLETELY COVERING THE ENTIRE RECORDING SYSTEM WITH A MESS OF ARTIFACT AND CAUSING A LOT OF ARTIFACT ON THE LASSO CHANNELS DISPLAYED ON CARTO, MAKING IT IMPOSSIBLE TO DECIPHER SIGNALS. THROUGHOUT THIS, THE LASSO CATHETER WAS STILL ABLE TO BE VISUALIZED ACCURATELY ON CARTO. THEY PROCEEDED TO CREATE SOME GEOMETRY. ALL TOGETHER THIS TROUBLESHOOTING STAGE WAS APPROXIMATELY 35 MINUTES. AFTER CREATING THE GEOMETRY, THEY UNPLUGGED THE LASSO CATHETER FROM THE PIU TO TAKE THE UNINTERRUPTABLE EGM'S OFF THE SCREEN AND ATTEMPTED TO INDUCE THE ARRHYTHMIA WITH OTHER CATHETERS IN THE PATIENT. AFTER INDUCING THE ARRHYTHMIA, THE PHYSICIAN RECONNECTED THE LASSO CATHETER TO THE CABLE (WHICH WAS ALREADY CONNECTED TO THE PIU) AND THERE WAS ONLY MINIMAL ARTIFACT SEEN ON THE LASSO CHANNELS AND THE EGM'S OR ECG'S WERE NOT DISTURBED. THEY WERE ABLE TO USE THE LASSO CATHETER TO COMPLETE THE CASE SUCCESSFULLY. AFTER THE CASE, THE ISSUE WAS DISCUSSED BETWEEN THE PHYSICIAN, NURSES, EP LAB STAFF AND THE BWI FIELD REPRESENTATIVE. IT WAS SUSPECTED THAT A SMALL AMOUNT OF WATER WAS INTRODUCED INTO THE CATHETER WHERE IT CONNECTS TO THE CABLE (EITHER THE OPEN END OF THE CABLE OR THE CONNECTING END OF THE CATHETER) GOT SPRAYED WITH THE FLUSH OF THE ABLATION CATHETER WHILE THE PHYSICIAN WAS CHECKING TO MAKE SURE THAT THE TIP OF THE ABLATION CATHETER WAS PROPERLY IRRIGATED. ALSO, THE FLUSH BOWL OF SALINE ON THE PATIENT¿S BED HAD OVERFLOWED, THEREFORE IT IS POSSIBLE THAT THE CABLE MAY HAVE COME INTO CONTACT WITH SOME DROPLETS OF WATER FROM THAT AS WELL. UPON REQUEST, ADDITIONAL INFORMATION WAS PROVIDED BY THE BWI FIELD REPRESENTATIVE. THE NOISE WAS ON ALL THE CHANNELS, INCLUDING THE 12 LEADS OF BODY SURFACE (BS) ECG¿S AND INTRACARDIAC (IC) SIGNALS ON BOTH THE CARTO AND PRUCKA RECORDING SYSTEM AT THE SAME TIME. WHILE THE NOISE WAS PRESENT(ANYTIME THE C3 NAVIGATIONAL VARIABLE LASSO CATHETER), THEY WERE UNABLE TO IDENTIFY ANY SIGNALS. THE ARTIFACT WAS LARGE ON ALL CHANNELS AND MADE IT IMPOSSIBLE TO EVEN SEE THE QRS COMPLEXES ON ANY OF THE ECG¿S. THE NOISE OCCURRED IMMEDIATELY AND EVERY TIME UPON CONNECTING THIS CATHETER TO THE PIU. THE NOISE WAS GONE IMMEDIATELY AND EVERY TIME THIS CATHETER WAS DISCONNECTED. THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE AFTER HAVING REBOOTED THE SYSTEM AND HAVING LEFT THE CATHETER DISCONNECTED FOR 20 MINUTES. UPON RECONNECTING THE CATHETER, THEY WERE ABLE TO INTERPRET THE SIGNALS. THERE WAS STILL SOME ARTIFACT AND NOISE ON THE LASSO EGM CHANNELS, BUT NO NOISE WAS SEEN ON THE EGMS FROM OTHER CATHETERS OR ECGS. THEREFORE, THEY PROCEEDED WITH THE CASE. NO PATIENT INJURY WAS REPORTED IN THIS EVENT. THE SEVERITY OF THE NOISE ON ALL THE CHANNELS, INCLUDING THE 12 LEADS OF BODY SURFACE (BS) ECG¿S AND INTRACARDIAC (IC) SIGNALS ON BOTH THE CARTO AND PRUCKA RECORDING SYSTEM AT THE SAME TIME IS INDICATIVE OF A REPORTABLE EVENT.

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS HAVE BEEN MADE TO REQUEST FOR THE COMPLAINT PRODUCT TO BE RETURNED FOR ANALYSIS. PRODUCT WAS NOT RETURNED FOR INVESTIGATION AS INITIALLY REPORTED. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED. THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. (B)(4)

    Additional Manufacturer Narrative · 1

    ON 8/6/2013, THE PRODUCT WAS RECEIVED IN THE BWI FAILURE ANALYSIS LAB. (B)(4) IT WAS REPORTED AS SOON AS THEY PLUGGED IN THE C3 NAVIGATIONAL VARIABLE LASSO CATHETER INTO THE PATIENT INTERFACE UNIT (PIU), AN ARTIFACT WAS SEEN ON EVERY EGM CHANNEL AND ALL OF THE ECG'S MAKING IT IMPOSSIBLE TO SEE ANY SIGNALS. UPON RECEIPT, THE DEVICE WAS VISUALLY INSPECTED AND IT WAS FOUND IN NORMAL CONDITIONS. THEN PER THE EVENT, THE CATHETER WAS ELECTRICALLY TESTED AND IT PASSED SPECIFICATIONS. THE DEVICE HISTORY RECORD (DHR) 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. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING THE ATRIAL FLUTTER LEFT (L-AFL) PROCEDURE, THE PHYSICIAN WANTED TO USE THE CARTO SYSTEM TO MAP. AFTER SETTING UP THE SYSTEM, ACCESS WAS OBTAINED AND SHEATHS WERE INSERTED. THE NAVISTAR ABLATION CATHETER AND THE C3 NAVIGATIONAL VARIABLE LASSO CATHETER WERE OPENED. THE NAVISTAR ABLATION CATHETER WAS INTRODUCED INTO THE PATIENT AND THEN CONNECTED TO CARTO WITH ANY PROBLEMS. NEXT THE C3 NAVIGATIONAL VARIABLE LASSO CATHETER WAS INTRODUCED INTO THE PATIENT. AS SOON AS THEY PLUGGED THE C3 NAVIGATIONAL VARIABLE LASSO CATHETER INTO THE CARTO PATIENT INTERFACE UNIT (PIU), AN ARTIFACT WAS SEEN ON EVERY EGM CHANNEL AND ON ALL OF THE ECG'S, MAKING IT IMPOSSIBLE TO SEE ANY SIGNALS. THE PHYSICIAN UNPLUGGED THE LASSO CABLE FROM THE PIU AND THE ARTIFACT DISAPPEARED. THE PHYSICIAN THEN PROCEEDED TO RE-PLUG THE LASSO CABLE IN, AND THE ARTIFACT RETURNED. THE BELOW TROUBLE SHOOTING WAS PERFORMED WHICH NONE WAS SUCCESSFUL: SWITCHED OUT THE CABLE CONNECTING THE LASSO TO THE PIU TWICE (WITH 2 NEW ADDITIONAL CABLES); SWITCHED OUT THE CABLE CONNECTING THE ABLATION CATHETER TO THE PIU; TRIED PLUGGING IN THE LASSO TO OTHER CONNECTION SLOTS ON THE PIU (IT WAS ORIGINALLY PLUGGED INTO SLOT "20 POLE A" SO THEY TRIED PLUGGING IT INTO "20 POLE B" AND THEN "REF/DECA"); SWITCHED OUT THE CABLE CONNECTING THE CARTO PIU TO THE STOCKERT RF GENERATOR; SWITCHED THE PATIENTS GROUNDING PAD; SWITCHED THE CABLE CONNECTING THE GROUNDING PAD TO THE STOCKERT; REBOOTED THE CARTO WORKSTATION; DID A FULL SHUTDOWN AND RESTART OF BOTH THE CARTO WORKSTATION AND PIU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296562 LASSO 2515 NAV VARIABLE CATHETER ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE DRF BIOSENSE WEBSTER, INC. (JUAREZ) D-1290-02-S 15665892L

    Patients

    Seq Age Sex Outcome Treatment
    1