BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATRIAL BASKET

    MDR report key: 230303 · Received June 30, 1999

    Report

    Report Number
    2020638-1999-00009
    Event Type
    Malfunction
    Date Received
    June 30, 1999
    Date of Event
    January 3, 1999
    Report Date
    March 23, 1999
    Manufacturer
    CORDIS WEBSTER INC.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    WHEN THE CATHETER WAS WITHDRAWN FROM THE PACKAGE, IT WAS REPORTED THAT THE SPINES WERE EXPANDED MORE THAN EXPECTED. THE PHYSICIAN PROCEEDED TO USE THE CATHETER, BUT EXPERIENCED RESISTANCE WHEN ATTEMPT WAS MADE TO PULL THE SPINES BACK INTO THE SHEATH. THE PHYSICIAN WAS ABLE TO WITHDRAW THE SPINES, BUT A CLOT WAS OBSERVED ON THE INSIDE OF THE DISTAL PART OF THE BASKET. IT WAS ALSO REPORTED THAT THE SPINES APPEARED TO BE EXPANDED MORE THAN BEFORE IT WAS INSERTED INTO THE ATRIUM. THERE IS NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATRIAL BASKET BASKET MAPPING CATHETER DQO CORDIS WEBSTER INC. ABB-10-P12-FS1 707369

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO