BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPER TORQUE

    MDR report key: 20884 · Received August 25, 1993

    Report

    Report Number
    20884
    Event Type
    Injury
    Date Received
    August 25, 1993
    Date of Event
    January 12, 1993
    Report Date
    January 19, 1993
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    AT APPROXIMATELY 10:00 A.M., A RIGHT 5-4 CORONARY CATHETER WAS INTRODUCED THROUGH A 5.2. FRENCH SHEATH WITH A GUIDEWIRE. THE GUIDEWIRE WAS REMOVED, THE CATHETER WAS FLUSHED BY PHYSICIAN. AORTIC PRESSURE WAS STABLE. CINE VIEW IN TH LAO PROJECTION WAS TAKEN. THE CATHETER WAS REPLACED INTO THE RIGHT CORONARY ARTERY, CINE VIEW IN THE RAO PROJECTION WAS TAKEN. THE PHYSICIAN ATTEMPTED TO REMOVE THE CATHETER FROM THE SHEATH AND WAS UNABLE TO REMOVE CATHETER AT THIS TIME, ATTEMPTED AGAIN TO UNSUCCESSFUL ATTEMPT, A GUIDEWIRE WAS INTRODUCED INTO THE CATHETER AND AN ATTEMPT WAS MADE TO REMVOE THE 5 RIGHT CATHETER. THE CATHETER LOOPED AND WAS SEEN OF FLUORO, THE WIRE COULD NOT BE ADVANCED. AN ATTEMPT WAS MADE TO TORQUE THE CATHETER TO UNLOOP IT AND THE CATHETER BROKE OFF (APPROXIMATELY 70CM). THE CATHETER PIECE LODGED IN THE SHEATH. PATIENT WAS STABLE, VITAL SIGNS: 117/50, HEART RATE 43.DR. PAGED AND PRESENT TO EVALUATE VASCULAR STATUS. POSITIVE POST TIBIAL PULASE PRESENT, FOOT PINK AND WARM.TWO DOCTORS INJECTED A SMALL AMOUNT OF CONTRAST TO ASCERTAIN LOCATION OF CATHETER PIECE. EMERGENCY OR ARRANGEENTS MADE BY FIRST DOCTOR. PATIENT TRANSPORTED TO OR WITH THE OTHER DOCTOR.SURGERY FOR REMOVAL OF CATHETER PERFORMED IMMEDIATELY AND SUCCESSFUL. INCISION MADE IN GROIN AREA. PSOT OPERATIVE COURSE UNEVENTFUL AND PATIENT WAS DISCHARGED JANUARY 13, 1993.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. THERE WAS NOT 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.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 SUPER TORQUE JR 4, 5.2F; 0.38"; 100 CM. MAX 1200 PSI (82.7 BAR) DQO CORDIS CORPORATION R 109 25 43 R1092543

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention