BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASSO® 2515 NAV ECO VARIABLE CATHETER

    MDR report key: 3495398 · Received December 2, 2013

    Report

    Report Number
    9673241-2013-00411
    Event Type
    Injury
    Date Received
    December 2, 2013
    Date of Event
    November 11, 2013
    Report Date
    November 11, 2013
    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
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER REPORTED 15974458L. CONCOMITANT PRODUCTS: THERMOCOOL EZ NAVIGATIONAL SF CATHETER, MODEL #: D-1317-05-S, LOT #: UNKNOWN. BARD DYNAMIC 10 POLES ¿NON BWI CATHETER. ST. JUDE SL1 INTRODUCER ¿ NON BWI CATHETER. (B)(4). EVENT DESCRIPTION CONTINUATION: THE PHYSICIAN REQUESTED THE HELP OF ANESTHETISTS AND THEY PUT THE PATIENT UNDER MECHANICAL VENTILATION. AT THIS POINT, THE SHEATH CAME BACK TO RIGHT SIDE AND THE PHYSICIAN MADE ANOTHER TRANSSEPTAL PUNCTURE. THEY STARTED ANOTHER NEW MAP AND WHILE THEY WERE MOVING THE LASSO NAVIGATIONAL VARIABLE ECO CATHETER CLOSE TO THE LEFT VEINS, THEY REALIZED THAT THE CATHETER TIP WAS BENT AT 90 DEGREES (BETWEEN ELECTRODE 2 AND 3). THEY TRIED TO OPEN AND CLOSE THE LOOP OF THE CATHETER AND THE LOOP MECHANISM WORKED PROPERLY BUT THE TIP WAS STILL BENT. THEY TRIED DIFFERENT OPERATIONS IN ORDER TO GETTING IT STRAIGHT WITH NO SUCCESS. AT THIS POINT, THE PHYSICIAN REQUESTED HELP FROM AN INTERVENTIONAL PHYSICIAN THAT TRIED TO CATCH THE CATHETER TIP WITH DIFFERENT "PIG TAIL" CATHETERS OF CORDIS WITH NO SUCCESS. BY MOVING THE CATHETER AFTER NUMEROUS ATTEMPTS, THE CATHETER GOT CAUGHT WITH THE MITRAL VALVE. DURING THE PROCEDURE AND THE MANEUVERS THE ACT WAS AROUND 260. AT THIS POINT, THEY DECIDED TO BRING THE PATIENT TO CARDIO SURGERY IN ORDER TO REMOVE THE CATHETER AND TO REPAIR THE MITRAL ANNULUS THAT WAS PERFORATED. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION. THE OUTCOME OF THE ADVERSE EVENT WAS THAT THE PATIENT FULLY RECOVERED WITH NO RESIDUAL EFFECTS. THE PHYSICIAN¿S OPINION REGARDING THE CAUSALITY WAS THAT IT WAS POSSIBLY DEVICE RELATED AND PROCEDURE RELATED. THE CATHETER WAS USED FOR FIVE HOURS WITHOUT PROBLEMS OR ERROR MESSAGES. THERE WERE NO OTHER FACTORS THAT MIGHT HAVE CONTRIBUTED TO THE PERFORATION. THE PHYSICIAN DID NOT NOTICE ANY ABNORMAL SIGNALS. THE PHYSICIAN DID NOT EXPERIENCE ANY DIFFICULTY IN MANIPULATING THE CATHETER.

    Additional Manufacturer Narrative · 1

    UPON VISUAL INSPECTION OF THE RETURNED COMPLAINT CATHETER ON DECEMBER 5, 2013, THE BWI FAILURE ANALYSIS LAB NOTED THE RETURNED CATHETER CONDITION WHICH WAS NOT ORIGINALLY REPORTED. THE CUSTOMER RETURNED TWO SMALL PIECES OF THE CUT CATHETER LASSO LOOP AND ONE PIECE OF THE LASSO LOOP WAS INSIDE THE 8FR ST. JUDE SHEATH TIP SECTION WHICH WAS INSIDE A SMALL JAR. THE MATERIAL WAS FOUND ON THE PU BALL TIP TO THE ELECTRODE RING #1 ON THE LASSO LOOP. THE ELECTRODE RINGS ARE DAMAGED AND ROUGH ABOVE THE PU MARGIN. THE 8FR ST. JUDE¿S SHEATH WAS CUT OFF ABOUT 37CMM FROM THE TIP. THE TIP WAS FOLDED OVER LIKE A CUFF WITH MORE OF THE LASSO LOOP INSIDE IT. THE THIRD PIECE OF THE LASSO LOOP THAT WAS RETURNED MEASURED ABOUT 7MM IN LENGTH WHICH HAD ONE DAMAGED ELECTRODE RING. THE TIP LUMEN WAS CUT ABOUT 42MM FROM THE TRANSITION AREA WITH DAMAGES ON VARIOUS AREAS ON THE TIP LUMEN. INVESTIGATION STILL IN PROGRESS. A SUPPLEMENTAL REPORT OR DEVICE EVALUATION WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WHILE MOVING THE LASSO NAVIGATIONAL VARIABLE ECO CATHETER CLOSE TO THE LEFT VEINS, THEY REALIZED THAT THE LASSO NAVIGATIONAL VARIABLE ECO CATHETER TIP WAS BENT AT 90 DEGREES (BETWEEN ELECTRODE 2 AND 3). THEY OPENED AND CLOSED THE CATHETER LOOP AND THE LOOP MECHANISM WORKED PROPERLY, BUT THE TIP WAS STILL BENT. AFTER NUMEROUS ATTEMPTS OF MOVING THE LASSO NAVIGATIONAL VARIABLE ECO CATHETER, IT GOT CAUGHT WITH THE MITRAL VALVE. UPON RECEIPT, THE CATHETER WAS VISUALLY INSPECTED AND THE CUSTOMER RETURNED TWO SMALL PIECES OF THE CUT CATHETER LASSO LOOP AND ONE PIECE OF THE LASSO LOOP INSIDE AN 8FR ST. JUDE SHEATH TIP SECTION WHICH WAS INSIDE A SMALL JAR. THERE WAS MATERIAL FOUND ON THE PU BALL TIP TO THE ELECTRODE RING #1 ON THE LASSO LOOP (APPEARS TO BE HUMAN TISSUE). THE ELECTRODE RINGS WERE DAMAGED AND ROUGH ABOVE THE PU MARGIN. THE 8FR ST. JUDE¿S SHEATH WAS CUT OFF ABOUT 37 MM FROM THE TIP. THE TIP WAS FOLDED OVER. THE THIRD PIECE OF THE LASSO LOOP THAT WAS RETURNED MEASURED ABOUT 7MM IN LENGTH WHICH HAD ONE DAMAGED ELECTRODE RING. THE TIP LUMEN WAS CUT ABOUT 42 MM FROM THE TRANSITION AREA WITH DAMAGES ON VARIOUS AREAS ON THE TIP LUMEN. NO FURTHER TESTING COULD BE PERFORMED DUE TO THE RETURNED CONDITION OF THE CATHETER. HOWEVER, THE DEFLECTION MECHANISM WAS CHECKED AND NO ANOMALIES WERE FOUND. 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 IFU STATES THAT CAREFUL MANIPULATION MUST BE PERFORMED IN ORDER TO AVOID CARDIAC DAMAGE, PERFORATION, OR TAMPONADE. THE REPORTED CUSTOMER COMPLAINT CANNOT BE CONFIRMED SINCE THE CATHETER WAS CUT OFF.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, FOUR DIFFERENT LEFT ATRIUM MAPS WERE MADE AS THE PATIENT WAS MOVING. THE PATIENT WAS THEN PUT UNDER TOTAL ANESTHESIA. AT THIS POINT, THE SHEATH CAME BACK TO RIGHT SIDE AND THE PHYSICIAN MADE ANOTHER TRANSSEPTAL PUNCTURE. A NEW MAP WAS STARTED. WHILE MOVING THE LASSO NAVIGATIONAL VARIABLE ECO CATHETER CLOSE TO THE LEFT VEINS, THEY REALIZED THAT THE LASSO NAVIGATIONAL VARIABLE ECO CATHETER TIP WAS BENT AT 90 DEGREES (BETWEEN ELECTRODE 2 AND 3). THEY OPENED AND CLOSED THE CATHETER LOOP AND THE LOOP MECHANISM WORKED PROPERLY, BUT THE TIP WAS STILL BENT. THE PHYSICIAN TRIED DIFFERENT OPERATIONS IN ORDER TO GETTING IT STRAIGHT WITHOUT SUCCESS. THE PHYSICIAN ASKED FOR HELP FROM AN INTERVENTIONAL PHYSICIAN THAT TRIED TO CATCH THE CATHETER TIP WITH DIFFERENT "PIG TAIL" CATHETERS FROM CORDIS. AFTER NUMEROUS ATTEMPTS OF MOVING THE LASSO NAVIGATIONAL VARIABLE ECO CATHETER, IT GOT CAUGHT WITH THE MITRAL VALVE. DURING THE MANEUVERS, THE ACT WAS AROUND 260. AT THIS POINT, IT WAS DECIDED TO BRING THE PATIENT TO CARDIO SURGERY. UPON REQUEST, ADDITIONAL INFORMATION WAS PROVIDED ON THE EVENT. THE EVENT WAS NOT LIFE THREATENING. THE EVENT DID NOT RESULT IN ANY IMPAIRMENT OF A BODY FUNCTION OR DAMAGE TO A BODY STRUCTURE. THE PROCEDURE WAS STARTED AT 11.50 WITH THE PATIENT AWAKE. THE FIRST MAP WAS MADE AND THEN THEY STARTED TO ABLATE. THEY ONLY ABLATED A FEW SECONDS AS THE PATIENT HAD PAIN. THE PHYSICIAN DECIDED TO CHANGE THE MEDICATIONS FOR ANALGESIA. IN THE MEAN TIME, THE PATIENT MOVED THEREFORE THEY HAD TO MAKE A NEW MAP. THEY TRIED TO START ABLATION BUT THE PATIENT HAD PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622754 LASSO® 2515 NAV ECO VARIABLE CATHETER CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER, INC. (JUAREZ) D-1343-01-S UNKNOWN_D-1343-01-S

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R