BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASSO 2515 VARIABLE CIRCULAR MAPPING CATHETER

    MDR report key: 1953193 · Received January 7, 2011

    Report

    Report Number
    9673241-2011-00006
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 17, 2010
    Report Date
    December 17, 2010
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    DRF
    PMA / PMN Number
    K031161
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THIS LASSO CATHETER HAVE A NICK ON THE SHAFT CLOSE TO THE LASSO LOOP. THE RETURNED COMPLAINT CATHETER WAS VISUALLY EXAMINED COMPARING THIS TO THE WORKMANSHIP CRITERIA ESTABLISHED; NO DAMAGES WERE FOUND DURING THIS EXAMINATION. COAGULUM WAS FOUND ON SOME OF THE RING ELECTRODES, ELECTRICAL TEST WAS PERFORMED TO THE CATHETER; THE ELECTRICAL LEAKAGE AND RESISTANCE PASSED SPECIFICATION. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. HOWEVER, IT DOES NOT APPEAR TO BE MANUFACTURING RELATED AS THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. COMPLAINT CANNOT BE CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING AN A-FIB PROCEDURE, THE LASSO CATHETER USED DISPLAYED A NICK IN THE SHAFT CLOSE TO THE LOOP PORTION AFTER IT WAS WITHDRAWN THROUGH THE SHEATH AT THE CONCLUSION OF THE CASE. THERE WAS NO PATIENT INJURY REPORTED. THE NICK WAS NOT NOTABLE VIA THE FLUOROSCOPY. THE PHYSICIAN MANAGED TO REMOVE THE CATHETER WITHOUT CAUSING ANY TISSUE TEAR. THE USERS WERE UNSURE IF THE NICK WAS PRESENT PRIOR TO INSERTION OF THE CATHETER OR NOT. THEY DID NOT DIRECTLY LOOK/CHECK. THERE WAS NO FORCE OR DIFFICULTY NOTED WHILE USING THIS CATHETER DURING THE PROCEDURE. ALSO NOTED WAS CHAR ON THE BOTTOM LEFT SIDE OF THE CATHETER NEAR THE LOOP. THE CHAR SIZE WAS APPROXIMATELY 2MM X2MM. THE DELIVERED POWER WAS 25-30 WATTS. APPROXIMATE DURATION OF THE ABLATIONS VARIED BETWEEN 60-360 SECONDS EACH. THE PHYSICIAN DID NOT NOTICE AN ABNORMAL CATHETER'S IRRIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LASSO 2515 VARIABLE CIRCULAR MAPPING CATHETER CATHETER, ELECTRODE RECORDING DRF BIOSENSE WEBSTER, INC. (JUAREZ) D-1237-01-S 15143080

    Patients

    Seq Age Sex Outcome Treatment
    1