BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASSO 2515 NAV VARIABLE CATHETER

    MDR report key: 3010409 · Received March 19, 2013

    Report

    Report Number
    9673241-2013-00071
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 13, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    DRF
    PMA / PMN Number
    K081258
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DURING THE PROCEDURE IT WAS REPORTED THE LASSO CATHETER WAS INTRODUCED INTO THE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) FOR MAPPING RVOT TACHYCARDIA. THE CATHETER WAS INTRODUCED VIA A STEERABLE SHEATH INTO THE RVOT. HOWEVER THE LASSONAV CATHETER WAS NOT ABLE TO BE RETRACTED OUT OF THE PATIENT. THE LASSONAV WAS CAUGHT IN THE TRICUSPID VALVE APPARATUS. THE PHYSICIAN APPLIED A LITTLE MORE FORCE AND THE CATHETER WAS THEN ABLE TO BE RETRACTED. HOWEVER THE CATHETER APPEARED TO HAVE RETRIEVED A PORTION OF THE TRICUSPID VALVE APPARATUS. THE PATIENT SURVIVED AND NO FURTHER INTERVENTION WAS REQUIRED. ADDITIONAL INFORMATION PROVIDED STATED THE PHYSICIAN'S REGARDING THE CAUSALITY OF THIS ADVERSE EVENT WAS DUE TO PROCEDURE-RELATED. THE PATIENT DID NOT REQUIRE ANY INTERVENTION/TREATMENT. PATIENT WAS DOING FINE. UPON RECEIPT, THE CATHETER WAS VISUALLY INSPECTED AND THE CATHETER WAS CUT 3.5 INCHES FROM THE LOOP. THIS SECTION WAS THE ONLY PART OF THE CATHETER THAT WAS RETURNED. THE REST OF THE CATHETER WAS NOT RETURNED FOR ANALYSIS. FURTHERMORE, FOREIGN MATERIAL WAS FOUND ON RINGS #1 AND #2. A FT-IR TEST WAS CARRIED OUT IN ORDER TO IDENTIFY THE TYPE OF FOREIGN MATERIAL. THE TEST RESULTS SUGGESTED THAT THIS MATERIAL HAD A BIOLOGICAL COMPOSITION SIMILAR TO THAT SHOWED BY HUMAN TISSUE. 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. ALL THE CATHETERS ARE INSPECTED FOR VISUAL DAMAGES BEFORE PACKAGING. ON LINE INSPECTIONS ARE IN PLACE TO PREVENT THIS TYPE OF DAMAGE/DEFECT FROM LEAVING THE FACILITY. IFU STATES THAT CARE SHOULD BE TAKEN WHEN USING THE CATHETER IN OR AROUND THE ATRIO-VENTRICULAR VALVE REGION TO PREVENT ENTANGLEMENT OF THE CATHETER WITH THE VALVES AND TO PREVENT SLIPPAGE OF THE CATHETER INTO THE VENTRICLES. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED DUE TO THE RETURN CONDITION OF THE CATHETER.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, IT WAS REPORTED THE LASSO CATHETER WAS INTRODUCED INTO THE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) FOR MAPPING RVOT TACHYCARDIA. THE CATHETER WAS INTRODUCED VIA A STEERABLE SHEATH INTO THE RVOT. HOWEVER, THE LASSONAV CATHETER WAS NOT ABLE TO BE RETRACTED OUT OF THE PATIENT. THE LASSONAV WAS CAUGHT IN THE TRICUSPID VALVE APPARATUS. THE PHYSICIAN APPLIED A LITTLE MORE FORCE AND THE CATHETER WAS THEN ABLE TO BE RETRACTED. HOWEVER THE CATHETER APPEARED TO HAVE RETRIEVED A PORTION OF THE TRICUSPID VALVE APPARATUS. THE PATIENT SURVIVED AND NO FURTHER INTERVENTION WAS REQUIRED. ADDITIONAL INFORMATION PROVIDED STATED THE PHYSICIAN'S REGARDING THE CAUSALITY OF THIS ADVERSE EVENT WAS DUE TO PROCEDURE-RELATED. THE PATIENT DID NOT REQUIRE ANY INTERVENTION/TREATMENT. PATIENT WAS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113304 LASSO 2515 NAV VARIABLE CATHETER ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE DRF BIOSENSE WEBSTER, INC. (JUAREZ) D-1290-01-S 15640864L

    Patients

    Seq Age Sex Outcome Treatment
    1 Other