BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASSO 2515 NAV VARIABLE CATHETER

    MDR report key: 2884596 · Received December 23, 2012

    Report

    Report Number
    9673241-2012-00379
    Event Type
    Injury
    Date Received
    December 23, 2012
    Date of Event
    November 26, 2012
    Report Date
    November 27, 2012
    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
    GR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT DURING AN A-FIB PROCEDURE, AFTER THE PHYSICIAN WAS FINISHING ABLATING AND VALIDATING AT THE LEFT ATRIUM, THE LASSO CATHETER WAS RETRACTED TO THE RIGHT ATRIUM (RA) IN ORDER TO MAP THE SUPERIOR VENA CAVA (FOR SVC ACTIVITY CHECK). HAVING THE LASSO AT THE RA THE PHYSICIAN REALIZED THAT THE CATHETER WAS SOMEHOW STUCK SOMEWHERE IN THE INFERIOR VENA CAVA (IVC)-RA JUNCTION. THE TIP OF THE LASSO CATHETER SEEMED TO BE KINKED AND STUCK AT THE BOTTOM OF THE RA, VERY CLOSE TO THE IVC. UPON RECEIPT, THE CATHETER WAS VISUALLY INSPECTED AND MOST OF THE LOOP COMPONENTS WERE FOUND DAMAGED. THEN PER THE EVENT, THE OD OF THE RING THAT WAS NOT DAMAGED WAS FOUND WITHIN SPECIFICATIONS. PER THE EVENT DESCRIPTION, THE CATHETER GOT STUCK AT THE BOTTOM OF THE RA CAUSING THE DAMAGE IN THE LOOP. 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 DEVICE HISTORY RECORD 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. IN ADDITION, 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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN A-FIB PROCEDURE, AFTER THE PHYSICIAN WAS FINISHING ABLATING AND VALIDATING AT THE LEFT ATRIUM, THE LASSO CATHETER WAS RETRACTED TO THE RIGHT ATRIUM (RA) IN ORDER TO MAP THE SUPERIOR VENA CAVA (FOR SVC ACTIVITY CHECK). HAVING THE LASSO AT THE RA THE PHYSICIAN REALIZED THAT THE CATHETER WAS SOMEHOW STUCK SOMEWHERE IN THE INFERIOR VENA CAVA (IVC)-RA JUNCTION. THE TIP OF THE LASSO CATHETER SEEMED TO BE KINKED AND STUCK AT THE BOTTOM OF THE RA, VERY CLOSE TO THE IVC. THE PHYSICIAN TRIED TO WITHDRAW THE CATHETER, USING THE SHEATH (DEFLECTABLE SHEATH FROM BARD, CHANNEL 8FR) AND ALL THE POSSIBLE MANEUVERS. HOWEVER, THEY COULD NOT RETRACT THE CATHETER INTO THE SHEATH. EVENTUALLY THE PHYSICIAN USED ENDOMYOCARDIAL BIOPSY FORCEPS FIRST, THEN A MULTI-SNARE CATHETER THROUGH THE SUBCLAVIAN VEIN TO RELEASE THE LASSO CATHETER. IT WAS REPORTED THAT A PIECE OF TISSUE WAS STUCK AT THE KINKED TIP OF THE CATHETER. THE PHYSICIAN OPINION REGARDING THE CAUSALITY OF THE EVENT WAS PROCEDURE RELATED AND POSSIBLE DEVICE RELATED. THE OUTCOME OF THE ADVERSE EVENT WAS FULLY RECOVERED AND THE PROGNOSIS FOR THE PATIENT WAS REPORTED AS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LASSO 2515 NAV VARIABLE CATHETER ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE DRF BIOSENSE WEBSTER, INC. (JUAREZ) D-1290-01-S 15671241L

    Patients

    Seq Age Sex Outcome Treatment
    1 Other