BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN CARDIOVASCULAR ACCESS

    MDR report key: 8095949 · Received November 21, 2018

    Report

    Report Number
    9616099-2018-02555
    Event Type
    Death
    Date Received
    November 21, 2018
    Date of Event
    April 9, 2009
    Report Date
    November 21, 2018
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DRE
    PMA / PMN Number
    K970392
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ARTICLE WAS FOUND DURING A RECENT LITERATURE SEARCH OF THIS DEVICE. PLEASE NOTE THAT PATIENT SPECIFIC DETAILS (DEMOGRAPHICS, MEDICAL HISTORY AND REASON FOR INTERVENTION) ARE NOT AVAILABLE. THE DEVICE IS AN UNKNOWN SHEATH AND THE CATALOG AND LOT NUMBERS ARE NOT AVAILABLE. CARLO, M. D., BORELLI, G., GISTRI, R., CIABATTI, N., MAZZONI, A., ARENA, M., & PETRONIO, A. S. (2009). EFFECTIVENESS OF THE TRANSRADIAL APPROACH TO REDUCE BLEEDINGS IN PATIENTS UNDERGOING URGENT CORONARY ANGIOPLASTY WITH GPIIB/IIIA INHIBITORS FOR ACUTE CORONARY SYNDROMES. CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, 74 (3), 408-415. DOI:10.1002/CCD.22008. THIS IS ONE OF THE PRODUCTS INVOLVED WITH THE REPORTED EVENT AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE: 9616099-2018-02554, 9616099-2018-02542, 9616099-2018-02540, 9616099-2018-02543, 9616099-2018-02548, 9616099-2018-02549, 9616099-2018-02550, 9616099-2018-02551. AS NOTED IN THE PUBLICATION BY DE CARLO ET AL., "EFFECTIVENESS OF THE TRANSRADIAL APPROACH TO REDUCE BLEEDINGS IN PATIENTS UNDERGOING URGENT CORONARY ANGIOPLASTY WITH GPIIB/IIIA INHIBITORS FOR ACUTE CORONARY SYNDROMES," CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS 74: 408¿415 (2009); REPORT 4 CASES OF PROCEDURAL MORTALITY, 2 IN THE FEMORAL GROUP AND 2 IN THE RADIAL GROUP AFTER USING AN 11-CM LONG 6F CORDIS SHEATH FOR PERCUTANEOUS CORONARY INTERVENTIONS (PCI). THE PRODUCTS WERE NOT RETURNED FOR ANALYSIS. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED WITHOUT A LOT NUMBER. WITHOUT THE RETURN OF THE DEVICE FOR ANALYSIS, PROCEDURAL FILMS, OR A DEATH CERTIFICATE THE REPORTED EVENT COULD NOT BE CONFIRMED, AND THE EXACT ROOT CAUSE COULD NOT BE DETERMINED. DEATH IS A WELL-KNOWN POTENTIAL ADVERSE EVENT. THIS COMPLICATION MAY OCCUR AT ANY TIME DURING OR AFTER THE PROCEDURE AND USERS ARE TRAINED AND EXPERIENCED IN HOW TO TREAT THIS COMMON COMPLICATION. ALTHOUGH A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED, PATIENT HISTORY, CLINICAL STATUS, COMORBIDITIES, AND PHARMACOLOGICAL FACTORS MAY BE POSSIBLE CONTRIBUTING FACTORS FOR THE PATIENT OUTCOME. WITHOUT A LOT NUMBER TO CONDUCT A DEVICE HISTORY RECORD (DHR) REVIEW, IT IS NOT POSSIBLE TO DETERMINE IF THE REPORTED FAILURE COULD BE RELATED TO THE MANUFACTURING PROCESS. THEREFORE, NO PREVENTATIVE OR CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    AS NOTED IN THE PUBLICATION BY DE CARLO ET AL., "EFFECTIVENESS OF THE TRANSRADIAL APPROACH TO REDUCE BLEEDINGS IN PATIENTS UNDERGOING URGENT CORONARY ANGIOPLASTY WITH GPIIB/IIIA INHIBITORS FOR ACUTE CORONARY SYNDROMES," CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS 74: 408¿415 (2009); REPORT 4 CASES OF PROCEDURAL MORTALITY, 2 IN THE FEMORAL GROUP AND 2 IN THE RADIAL GROUP AFTER USING AN 11-CM LONG 6F CORDIS SHEATH FOR PERCUTANEOUS CORONARY INTERVENTIONS (PCI).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    933682 UNKNOWN CARDIOVASCULAR ACCESS DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE CORDIS CORPORATION UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death