BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIGTAIL AORTIC FLUSH CATHETER

    MDR report key: 4007 · Received July 17, 1992

    Report

    Report Number
    4007
    Event Type
    Injury
    Date Received
    July 17, 1992
    Date of Event
    March 11, 1992
    Report Date
    July 17, 1992
    Manufacturer
    CORDIS CORPORATION
    Product Code
    KRA
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    DURING CARDIAC CATHERIZATION, THE DISTAL END OF THE CATHETER KINKED UPON PLACEMENT INTO THE L VENTRICAL. UPON REMOVAL INTO THE DESCENDING AORTA, THE KINKING BECAME KNOTTED. KNOTTED TIP BROKE OFF AND WEDGED IN PROXIMAL POSITION OF L FEMORAL ARTERY REQUIRING SURGICAL REMOVALINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. 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. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED. INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIGTAIL AORTIC FLUSH CATHETER KRA CORDIS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention