BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CARDIOVASCULAR ACCESS

    MDR report key: 8351087 · Received February 19, 2019

    Report

    Report Number
    9616099-2019-02733
    Event Type
    Injury
    Date Received
    February 19, 2019
    Date of Event
    March 6, 2003
    Report Date
    February 19, 2019
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DRE
    PMA / PMN Number
    K970392
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS NOTED IN A LITERATURE PUBLICATION BY KESSEL, D. O., ROBERTSON, I., TAYLOR, E. J., & PATEL, J. V. (2003). RENAL STENTING FROM THE RADIAL ARTERY: A NOVEL APPROACH. CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY, 25 (2), 146-149. DOI: 10.1007/S00270-001-0114-7; TWO PATIENTS COMPLAINED OF COLDNESS OF THE HAND DURING THE PROCEDURE; IN BOTH CASES THIS RESPONDED TO INTRA-ARTERIAL ADMINISTRATION OF GLYCERYL TRINITRATE (GTN) AT THE END OF THE PROCEDURE. NO PATIENT HAS SUBSEQUENTLY COMPLAINED OF SYMPTOMS OF HAND ISCHEMIA. THE PROCEDURE WAS RENAL STENTING FROM THE RADIAL ARTERY. A CONVENTIONAL 11CM 5F CORDIS SHEATH WAS USED. THE DEVICES WERE NOT RECEIVED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBERS ARE NOT AVAILABLE, THE DEVICE HISTORY RECORD (DHR) REVIEWS COULD NOT BE PERFORMED. WITHOUT THE RETURN OF THE DEVICES FOR ANALYSIS OR PROCEDURAL FILMS, THE REPORTED EVENTS COULD NOT BE CONFIRMED AND THE EXACT ROOT CAUSE COULD NOT BE DETERMINED. COLDNESS OF THE HAND DURING THE PROCEDURE IS A WELL-KNOWN POTENTIAL ADVERSE EVENT AND USUALLY OCCURS DUE TO DECREASED BLOOD FLOW TO THE HANDS AND CAN BE RESULTING FROM INVASIVE RADIAL PROCEDURES. 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. 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. KESSEL, D. O., ROBERTSON, I., TAYLOR, E. J., & PATEL, J. V. (2002). RENAL STENTING FROM THE RADIAL ARTERY: A NOVEL APPROACH. CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY, 25 (2), 146-149. DOI: 10.1007/S00270-001-0114-7. THIS ARTICLE WAS FOUND DURING A RECENT CLINICAL EVALUATION REVIEW/LITERATURE SEARCH OF THIS DEVICE. PLEASE NOTE THAT PATIENT SPECIFIC DETAILS (DEMOGRAPHICS, MEDICAL HISTORY AND REASON FOR INTERVENTION) ARE NOT AVAILABLE. THE DEVICES ARE SAVVY BUT THE CATALOG AND LOT NUMBERS ARE NOT AVAILABLE.

    Description of Event or Problem · 1

    AS NOTED IN A LITERATURE PUBLICATION BY KESSEL, D. O., ROBERTSON, I., TAYLOR, E. J., & PATEL, J. V. (2003). RENAL STENTING FROM THE RADIAL ARTERY: A NOVEL APPROACH. CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY, 25 (2), 146-149. DOI: 10.1007/S00270-001-0114-7; TWO PATIENTS COMPLAINED OF COLDNESS OF THE HAND DURING THE PROCEDURE; IN BOTH CASES THIS RESPONDED TO INTRA-ARTERIAL ADMINISTRATION OF GLYCERYL TRINITRATE (GTN) AT THE END OF THE PROCEDURE. NO PATIENT HAS SUBSEQUENTLY COMPLAINED OF SYMPTOMS OF HAND ISCHEMIA. THE PROCEDURE WAS RENAL STENTING FROM THE RADIAL ARTERY. A CONVENTIONAL 11CM 5F CORDIS SHEATH WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144592 UNKNOWN CARDIOVASCULAR ACCESS DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE CORDIS CORPORATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R