BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASSO® 2515 NAV ECO VARIABLE CATHETER

    MDR report key: 4861990 · Received June 23, 2015

    Report

    Report Number
    9673241-2015-00387
    Event Type
    Injury
    Date Received
    June 23, 2015
    Date of Event
    June 1, 2015
    Report Date
    June 1, 2015
    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
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS DISCARDED, THEREFORE NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED. THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. CONCOMITANT MEDICAL PRODUCTS: NON BWI - SRO 8.5F SHEATH; NON BWI - BRK-1 NEEDLE; NON BWI ¿ ST. JUDE MEDICAL AGILIS SHEATH; THERMOCOOL SMART TOUCH D CURVE, MODEL #: UNKNOWN, LOT #: UNKNOWN; C3 EXTERNAL REFERENCE PATCH, MODEL #: D-1283-02, LOT 3: UNKNOWN; COOLFLOW TUBING SET, MODEL #: D-1233-01-S, LOT #: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT, (B)(6), MALE, UNDERWENT A RE-DO ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A LASSO NAVIGATIONAL VARIABLE ECO CATHETER AND SUFFERED A CARDIAC VALVE RUPTURE WHICH REQUIRED SURGICAL INTERVENTION. THE PATIENT WAS BROUGHT IN AS AN EMERGENCY RE-DO PULMONARY VEIN ISOLATION (PVI) ABLATION PROCEDURE AS A RESULT OF A REPEATED SHORTNESS OF BREATH (SOB) SYMPTOMS. THE PATIENT WAS PUT UNDER GENERAL ANESTHESIA. THE LASSO NAVIGATIONAL VARIABLE ECO CATHETER WAS USED TO COLLECT FAST ANATOMICAL MAPPING (FAM) OF THE LEFT ATRIUM (LA). AS THE LASSO NAVIGATIONAL VARIABLE ECO CATHETER REACHED NEAR THE MITRAL VALVE REGION OF THE LA, THE PATIENTS¿ PRESSURE DROPPED. FURTHER INVESTIGATIONS OF THE PRESSURE DROP, REVEALED THAT THE CATHETER TIP WAS CAUGHT DISTALLY (POLE 1-2) NEAR THE MITRAL VALVE APPARATUS / CHORDAE TENDONS. THE CATHETER WOULD NOT FREE FROM THE VALVE. THE SURGEONS OPTED TO TRANSFER THE PATIENT TO THE OR TO SURGICALLY REMOVE THE CATHETER IMMEDIATELY. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THIS WAS A LIFE THREATENING SITUATION. THERE WAS A CONFIRMED POSTERIOR CHORDAE TENDONEAE DAMAGE WHICH REQUIRED OPEN HEART SURGERY. EXTENDED HOSPITAL STAY WAS REQUIRED FOR THIS PATIENT. THE PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THIS ADVERSE EVENT WAS PROCEDURE RELATED. THE LASSO ¿INSTRUCTIONS FOR USE¿ STATES, ¿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.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405957 LASSO® 2515 NAV ECO VARIABLE CATHETER CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER, INC. (JUAREZ) D-1343-01-S 17213954L

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Life Threatening| R