BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVANTI + 5F STD W/GW

    MDR report key: 12331059 · Received August 17, 2021

    Report

    Report Number
    9616099-2021-04784
    Event Type
    Injury
    Date Received
    August 17, 2021
    Date of Event
    July 21, 2021
    Report Date
    August 17, 2021
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DRE
    UDI-DI
    10705032009980
    PMA / PMN Number
    K970392
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORTED, DURING A DIAGNOSTIC HEART CATHETERIZATION FROM THE LEFT FEMORAL APPROACH, THE DOCTOR EXPERIENCED DIFFICULTY WHEN FLUSHING THE 5F STANDARD (STD) WITH GUIDEWIRE (GW) AVANTI PLUS CATHETER SHEATH INTRODUCER (CSI). WHEN CONTINUING TO FLUSH, THE DOCTOR NOTICED BLOOD CLOTS COMING OUT OF THE SIDE ARM OF THE SHEATH, INDICATING THAT CLOTTING HAD BEEN OCCURRING IN THE SHEATH CANNULA. THE PATIENT WAS ANTICOAGULATED WITH AN INTERNATIONAL NORMALIZED RATIO (INR) OF 2 WHICH CONCERNED THE DOCTOR. HE WAS ABLE TO FINISH THE CASE WITH THE SAME SHEATH WITH NO INJURY TO THE PATIENT. THE DOCTOR WAS A VERY EXPERIENCED FEMORAL ONLY ACCESS OPERATOR WHO HAS USED CORDIS SHEATHS HIS ENTIRE CAREER. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A PRODUCT HISTORY RECORD (PHR) REVIEW OF LOT 17914442 REVEALED NO ANOMALIES OR NON-CONFORMANCES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED EVENT. THE REPORTED "THROMBOSIS IN DEVICE" COULD NOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THROMBOSIS WITHIN THE DEVICE DOES NOT REPRESENT A DEVICE MALFUNCTION. CLINICAL FACTORS THAT MAY HAVE INFLUENCED THE EVENT INCLUDE THE PATIENTS PRE-EXISTING COMORBIDITIES, PHARMACOLOGICAL AND LESION CHARACTERISTICS. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), WHICH IS NOT INTENDED AS A MITIGATION OF RISK, "AFTER ASPIRATION AND FLUSHING, CONSIDER ESTABLISHING A HEPARINIZED SOLUTION OR SUITABLE ISOTONIC SOLUTION VIA THE SIDEPORT EXTENSION. THE ADDITION OF A HEPARINIZED SALINE DRIP VIA THE SIDEPORT CAN HELP IN THE PREVENTION OF THROMBUS FORMATION. POSSIBLE COMPLICATIONS INCLUDE BUT ARE NOT LIMITED TO: THROMBUS FORMATION." NEITHER THE PHR NOR THE INFORMATION AVAILABLE SUGGESTS A DESIGN OR MANUFACTURING RELATED CAUSE FOR THE REPORTED EVENT; THEREFORE, NO CORRECTIVE/PREVENTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED, DURING A DIAGNOSTIC HEART CATHETERIZATION FROM THE LEFT FEMORAL APPROACH, THE DOCTOR EXPERIENCED DIFFICULTY WHEN FLUSHING THE 5F STANDARD (STD) WITH GUIDEWIRE (GW) AVANTI PLUS CATHETER SHEATH INTRODUCER (CSI). WHILE CONTINUING TO FLUSH, THE DOCTOR NOTICED BLOOD CLOTS COMING OUT OF THE SIDE ARM OF THE SHEATH INDICATING THAT CLOTTING HAD BEEN OCCURRING IN THE SHEATH CANNULA. THE PATIENT WAS ANTICOAGULATED WITH AN INTERNATIONAL NORMALIZED RATIO (INR) OF 2 WHICH CONCERNED THE DOCTOR. HE WAS ABLE TO FINISH THE CASE WITH THE SAME SHEATH WITH NO INJURY TO THE PATIENT. THE DOCTOR WAS A VERY EXPERIENCED FEMORAL ONLY ACCESS OPERATOR WHO HAS USED CORDIS SHEATHS HIS ENTIRE CAREER. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT WAS DISCARDED POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1227548 AVANTI + 5F STD W/GW DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE CORDIS CORPORATION 504605X 17914442 10705032009980

    Patients

    Seq Age Sex Outcome Treatment
    1 ANTICOAGULANT