BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO® 3 SYSTEM INTERFACE CABLE

    MDR report key: 2810270 · Received October 31, 2012

    Report

    Report Number
    2029046-2012-00146
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 1, 2012
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    DQK
    PMA / PMN Number
    K090017
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT INVESTIGATION WILL NOT BE PERFORMED SINCE WE WERE NOTIFIED BY THE BWI FIELD REPRESENTATIVE THAT THE PRODUCT WAS DISCARDED. SINCE NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD REVIEW COULD BE PERFORMED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE CONCOMITANT PRODUCTS: SMART TOUCH BIDIRECTIONAL, MODEL# D-1327-00-S, LOT # UNKNOWN (NOT FDA APPROVED). (B)(4) ARE RELATED TO THE SAME EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN AFIB PROCEDURE, ALL ECG SIGNALS WERE FLAT LINED AND THAT IT APPEARED THAT ELECTRICAL SIGNAL CAME TO THE PATIENT. UPON FOLLOW UP, BWI RECEIVED THE INFORMATION ON (B)(6) 2012 (WHICH CHANGED THE ALERT DATE) THAT SHOWED WHEN THE PHYSICIAN CONNECTED THE INTERFACE CABLE TO THE SMART TOUCH CATHETER, THE PATIENT WAS FEELING PAIN IN THE CHEST AND BY DISCONNECTING THE SMART TOUCH CATHETER THE PATIENT SAID THAT THE PAIN WAS GONE. THE PHYSICIAN ASSUMED THAT THERE WAS A LEAK-CURRENT FROM SMART TOUCH CATHETER TO THE PATIENT THEREFORE THE PHYSICIAN STOPPED THE CARTO PROCEDURE AND FINISHED THE PROCEDURE WITHOUT THE CARTO. AFTER CHECKING THE USED PRODUCTS THEY FOUND THAT THEY USED THE WRONG INTERFACE CABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARTO® 3 SYSTEM INTERFACE CABLE COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER, INC (IRWINDALE) D-1286-03-S OEM_D-1286-03-S

    Patients

    Seq Age Sex Outcome Treatment
    1 SEE H10 SECTION