BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER

    MDR report key: 5028138 · Received August 25, 2015

    Report

    Report Number
    9673241-2015-00552
    Event Type
    Injury
    Date Received
    August 25, 2015
    Date of Event
    July 27, 2015
    Report Date
    July 27, 2015
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    MTD
    PMA / PMN Number
    K123837
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. METHODS: NO TESTING METHODS PERFORMED. RESULTS: NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED. CONCLUSION: DEVICE DISCARDED BY USER, UNABLE TO FOLLOW-UP. (B)(4) CONCOMITANT PRODUCTS: DISTRIBUTED ACUNAV CATHETER, MODEL #: M-5723-09, SOUNDSTAR ECO CATHETER, MODEL #: M-5723-17, EZ STEER THERMOCOOL SF NAV CATHETER, MODEL #: D-1313-05-S, LOT #: UNKNOWN_D-1313-05-S. CARTO SYSTEM. STOCKERT 70 SYSTEM, MODEL #: M-5463-01, SERIAL #: (B)(4), COOLFLOW PUMP, MODEL #: M-5491-02, SERIAL #: (B)(4). (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MID SIXTY MALE PATIENT UNDERWENT A ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A PENTARAY NAVIGATIONAL ECO CATHETER AND SUFFERED A ST SEGMENT ELEVATION. THE PATIENT'S MEDICAL HISTORY IS UNKNOWN. THE PATIENT WAS UNDER GENERAL ANESTHESIA. A "NO TRANSDUCER" ERROR POPULATED. THE SWIFTLINK WAS REPLACED AND THE ISSUE DID NOT RESOLVE. THE SOUNDSTAR ECO CATHETER WAS REPLACED WITH AN ACUNAV CATHETER AND THE ISSUE RESOLVED. THE PROCEDURE WAS THEN CONTINUED. LATER IN THE PROCEDURE, THE PATIENT HAD AN ST SEGMENT ELEVATION NOTED INFERIORLY WHICH RESOLVED ON ITS OWN WITHOUT ANY INTERVENTION. ONLY THE PENTARAY NAVIGATIONAL CATHETER AND THE ACUNAV CATHETER WERE IN THE PATIENT AT THE TIME OF THE ST SEGMENT ELEVATION. NO MAPPING OR ABLATION WHERE PERFORMED WITH THE ABLATION CATHETER. AFTER THE EP PROCEDURE, THEY DECIDED TO DO A HEART CATHETERIZATION TO DETERMINE IF IT WAS ISCHEMIC. THERE WERE BLOCKAGES IN THE CORONARY NOTED. HOWEVER, THE PERCENTAGES WERE NOT KNOWN. THERE IS NO INFORMATION ABOUT THE HOSPITALIZATION. PER THE CALLER'S KNOWLEDGE, THE PATIENT DID NOT REQUIRE ANY ADDITIONAL CARE. NO FURTHER INFORMATION IS KNOWN REGARDING THE PATIENT STATUS. THE SYSTEMS WORKED WITHOUT AN ISSUE. THE PHYSICIAN DID NOT THINK IT WAS RELATED TO PRODUCT USAGE. SINCE WE CAN NOT CONFIRM IF PROLONGED HOSPITALIZATION WAS REQUIRED, TO BE CONSERVATIVE, THIS EVENT HAS BEEN ASSESSED AS A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563024 PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD BIOSENSE WEBSTER, INC. (JUAREZ) D-1282-11-S UNKNOWN_D-1282-11-S

    Patients

    Seq Age Sex Outcome Treatment
    1 Other