BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASSO® 2515 NAV ECO VARIABLE CATHETER

    MDR report key: 3920207 · Received July 8, 2014

    Report

    Report Number
    9673241-2014-00252
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    March 24, 2014
    Report Date
    April 1, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    DRF
    PMA / PMN Number
    K113213
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION (AF) PROCEDURE WITH A LASSO 2515 NAV ECO VARIABLE CATHETER AND THE DEVICE BECAME ENTRAPPED IN THE PATIENT¿S MITRAL VALVE POSTERIOR LEAFLET (A VALVE THAT IS LOCATED BETWEEN THE LEFT ATRIUM AND LEFT VENTRICLE). THE CATHETER WAS FREED AFTER APPROXIMATELY ONE HOUR OF MANIPULATION WHICH INCLUDED ADVANCEMENT AND CLOCKWISE ROTATION. ONCE THE DEVICE WAS REMOVED, IT WAS NOTED THAT THERE WERE DEFLECTION ISSUES AND SEVERAL ABNORMAL KINKS IN THE CATHETER. THE BWI FAILURE ANALYSIS LAB RECEIVED THE COMPLAINT CATHETER. UPON RECEIPT, THE CATHETER WAS VISUALLY INSPECTED AND IT WAS NOTED THAT RING #2 WAS LIFTED AND THE CATHETER TIP WAS TWISTED. THESE CONDITIONS ARE CAUSED BY CATHETER MANEUVERING AND EXCESSIVE FORCE APPLICATION. PER THE REPORTED EVENT, A DEFLECTION AND CONTRACTION TESTS WERE PERFORMED AND BOTH MECHANISMS WERE WORKING PROPERLY. HOWEVER, THE MOVEMENT OF THE CATHETER WAS ABNORMAL DUE TO THE TIP SECTION BEING TWISTED. NEITHER THE DEFLECTION NOR THE CONTRACTION GOT STUCK DURING THE ANALYSIS. IT REMAINS UNKNOWN HOW THE LASSO WAS TRAPPED IN THE MITRAL VALVE. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED SINCE THE RESULTS DEMONSTRATED THAT THE DEFLECTION AND CONTRACTION MECHANISMS WERE PROPERLY WORKING. ADDITIONALLY, THE INSTRUCTIONS FOR USE (IFU) CLEARLY STATES THAT TO PREVENT ENTANGLEMENT OF THE CATHETER WITH THE VALVES AND TO PREVENT SLIPPAGE OF THE CATHETER INTO THE VENTRICLES, CARE SHOULD BE TAKEN WHEN USING THE CATHETER IN OR AROUND THE ATRIO-VENTRICULAR VALVE REGION. 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.

    Additional Manufacturer Narrative · 1

    WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. THE DEVICE HISTORY RECORD(S) 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. CONCOMITANT PRODUCTS: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION (AF) PROCEDURE WITH A LASSO 2515 NAV ECO VARIABLE CATHETER AND THE DEVICE BECAME ENTRAPPED IN THE PATIENT. WHEN THE LASSO WAS INTRODUCED TO THE LEFT ATRIUM, DR (B)(6) OBSERVED THAT THE LOOP APPEARED TO BE DEFLECTED AT AN ODD ANGLE TO THE SHAFT ¿ OBLIQUE. WHILE THE PHYSICIAN MANEUVERED THE CATHETER, THE LOOP APPEARED TO BECOME TRAPPED IN THE PATIENT¿S MITRAL VALVE POSTERIOR LEAFLET (A VALVE THAT IS LOCATED BETWEEN THE LEFT ATRIUM AND LEFT VENTRICLE). FURTHER MOVEMENT SUCH AS WITHDRAWAL, ADVANCEMENT AND CLOCKWISE ROTATION DID NOT FREE THE LOOP. THE CATHETER WAS FREED AFTER APPROXIMATELY ONE HOUR AND UPON REMOVAL OF THE CATHETER, IT WAS NOTED THAT THERE WERE DEFLECTION ISSUES AND SEVERAL ABNORMAL KINKS IN THE CATHETER. THE PROCEDURE WAS PROLONGED BY 1 HOUR WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SIMILAR-LIKE DEVICE, AND THE PATIENT EXPERIENCED NO ADVERSE EVENTS, AS CONFIRMED BY ECHOCARDIOGRAM AND AN OVERNIGHT HOSPITAL STAY. THERE APPEAR TO HAVE BEEN DEVIATIONS IN THE PROCEDURE AND THE RECOMMENDED BWI INSTRUCTIONS FOR USE (IFU). THE APPLICABLE INSTRUCTIONS FOR USE STATE THAT DUE TO THE ¿RISK OF ENTRAPPING THE LASSO CATHETER IN THE LEFT VENTRICLE¿[IT] IS NOT RECOMMENDED FOR USE IN THE VENTRICLES.¿ THE PHYSICIAN TRIED TO REMOVE THE CATHETER IN A CLOCKWISE ROTATION, BUT, THE IFU WARNS: "TO REDUCE THE RISK OF ENTRAPPING CARDIAC STRUCTURES ¿PLACE THE LASSO CATHETER BY TORQUING (OR ROTATING) THE SHAFT IN A CLOCKWISE MOTION ONLY." AS SUCH, THE CATHETER SHOULD BE REMOVED IN COUNTERCLOCKWISE MOTION. ORIGINALLY, THE PRODUCT WAS NOT RETURNED TO BWI. HOWEVER, THE AWARENESS DATE WAS UPDATED FROM MARCH 31, 2014 TO JUNE 10, 2014, DUE TO RECENT PRODUCT RETURN AND FINDINGS FROM THE BWI FAILURE ANALYSIS LAB. THE LAB FOUND THAT ONE OF THE CATHETER¿S ELECTRODE RINGS WAS LIFTED DISTALLY FROM THE TIP AND THAT THE TIP OF THE CATHETER WAS TWISTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397274 LASSO® 2515 NAV ECO VARIABLE CATHETER CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER, INC. (JUAREZ) D-1343-01-S 16025001L

    Patients

    Seq Age Sex Outcome Treatment
    1