BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CARDIOVASCULAR ACCESS

    MDR report key: 8349551 · Received February 19, 2019

    Report

    Report Number
    9616099-2019-02730
    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; THERE WAS ONE SMALL PUNCTURE SITE HEMATOMA. IN THIS PATIENT, THE RADIAL PULSE COULD NOT BE PALPATED THE FOLLOWING DAY BUT HAD RETURNED AT ONE WEEK. THE PROCEDURE WAS RENAL STENTING FROM THE RADIAL ARTERY. A CONVENTIONAL 11CM 5F CORDIS SHEATH WAS USED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. WITHOUT A LOT NUMBER AVAILABLE, THE DEVICE HISTORY RECORD (DHR) REVIEW FOR THE DEVICE WAS UNABLE TO BE CONDUCTED. WITHOUT THE RETURN OF THE DEVICE FOR ANALYSIS OR IMAGES FOR REVIEW, THE REPORTED CUSTOMER EVENT COULD NOT BE CONFIRMED. HEMATOMA IS A WELL-KNOWN POTENTIAL ADVERSE EVENT AND CAN BE RESULTING FROM INVASIVE 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. ALTHOUGH A CONCLUSIVE ROOT CAUSE MAY NOT BE DETERMINED, HEMATOMAS ARE FREQUENTLY RELATED TO STICK TECHNIQUE, ANTICOAGULATION, BLOOD PRESSURE, ADEQUATE SHEATH REMOVAL TECHNIQUE AND THE PATIENT'S COMPLIANCE TO DECREASE MOBILITY OF THE LIMB AFFECTED IN ORDER TO PROMOTE COAGULATION. GIVEN THE LIMITED INFORMATION AVAILABLE FOR REVIEW AT THIS TIME, AND WITHOUT A LOT NUMBER TO CONDUCT A DHR, THERE IS NOTHING TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO THE DESIGN AND MANUFACTURING PROCESS OF THE DEVICE. THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN. 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; THERE WAS ONE SMALL PUNCTURE SITE HEMATOMA. IN THIS PATIENT, THE RADIAL PULSE COULD NOT BE PALPATED THE FOLLOWING DAY BUT HAD RETURNED AT ONE WEEK. 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
    144241 UNKNOWN CARDIOVASCULAR ACCESS DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE CORDIS CORPORATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R