BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEFLECTIBLE D-CURVE ABLATION CATHETER

    MDR report key: 29314 · Received December 4, 1995

    Report

    Report Number
    29314
    Event Type
    Injury
    Date Received
    December 4, 1995
    Date of Event
    November 22, 1995
    Report Date
    December 4, 1995
    Manufacturer
    CORDIS WEBSTER, INC.
    Product Code
    LPB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT IN CARDIAC CATH LAB FOR ABLATION. CATHETER PRESENT IN RIGHT ATRIUM. WHILE PHYSICIAN WAS REPOSITIONING THE CATHETER UNDER FLUOROSCOPY, CATHETER TIP WAS NOTED TO BE DETACHED FROM CATHETER. PHYSICIAN ATTEMPTED RETRIEVAL; UNABLE TO RETRIEVE. PHYSICIAN CONTACTED MFR WHO STATED THAT PREVIOUS EXPERIENCE INDICATED CATHETER TIP COULD SAFELY BE LEFT IN CURRENT POSITION (WEDGED INTO CORONARY SINUS). PT KEPT OVERNIGHT FOR OBSERVATION; DISCHARGED HOME FOLLOWING DAY. CATHETER TIP AND APPROXIMATELY 2 MM OF CATHETER TUBING LEFT IN PT. (LABEL)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEFLECTIBLE D-CURVE ABLATION CATHETER CATHETER LPB CORDIS WEBSTER, INC. 411044

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Hospitalization