BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ STEER DS BI-DIRECTIONAL NAVIGATIONAL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATH

    MDR report key: 1421963 · Received March 26, 2009

    Report

    Report Number
    9673241-2009-00007
    Event Type
    Malfunction
    Date Received
    March 26, 2009
    Date of Event
    January 22, 2009
    Report Date
    January 22, 2009
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    OAD
    PMA / PMN Number
    P010068/S6
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF THE CATHETER, IT WAS NOTICED THAT THE SOFT TIP WAS TORN. VISUAL INSPECTION INDICATED THAT THE SOFT TIP WAS TORN BELOW ELECTRODE #2 AND THE BRAID FROM THE SOFT TIP MATERIAL WAS STICKING OUT. THE DAMAGED AREA FROM THE SOFT TIP OF THE CATHETER SHOWED STRETCHED MARKS AND TEAR. THE DAMAGE FOUND IN THE COMPLAINT SAMPLE SUGGESTED THAT EXCESSIVE FORCE WAS APPLIED. SAMPLES WERE OBTAINED FROM FINISHED GOODS INVENTORY (FGI) AND TESTED AS AN ATTEMPT TO RECREATE THE FAILURE CONDITION OF TORN SOFT TIP. THE FAILURE CONDITION COULD NOT BE REPRODUCED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE ARTIFACTS WHEN THIS CATHETER WAS IN USE. THIS EVENT DESCRIPTION WAS NOT INDICATIVE OF A REPORTABLE MALFUNCTION. HOWEVER, THE RETURNED CATHETER HAD A TORN TIP. THIS WAS DISCOVERED BY BIOSENSE WEBSTER IN 2009, UPON RECEIPT OF THE COMPLAINT SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EZ STEER DS BI-DIRECTIONAL NAVIGATIONAL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATH OAD CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF OAD BIOSENSE WEBSTER, INC. (JUAREZ) D-1260-05-S 13455018

    Patients

    Seq Age Sex Outcome Treatment
    1