BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TYSHACK PEDIATRIC DILATION CATHETER

    MDR report key: 8943 · Received July 22, 1993

    Report

    Report Number
    8943
    Event Type
    Injury
    Date Received
    July 22, 1993
    Date of Event
    November 9, 1992
    Report Date
    January 25, 1993
    Manufacturer
    ANGEION CORPORATION
    Product Code
    LWT
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    CATHETER RUPTURED DURING USE. THE TIP LODGED AT THE JUNCTION OF THE INFERIOR VENA CAVA AND RIGHT ATRIUM. THE TIP REQUIRED RETRIEVAL BY SNARE. ON EXAMINATION BY CLINICAL ENGINEERING THE BALLOON RUPTURED 2.5CM FROM PROXIMAL END. THE TIP OF THE CATHETER MEASURED 4.2CM AND WAS SEPARATED FROM THE CATHETER.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: COMPONENT FAILURE, OTHER. CONCLUSION: DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: MAYBE. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TYSHACK PEDIATRIC DILATION CATHETER UNKNOWN LWT ANGEION CORPORATION PDC06 20BC59, P1350

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Required Intervention