BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CARDIOVASCULAR ACCESS

    MDR report key: 8086310 · Received November 19, 2018

    Report

    Report Number
    9616099-2018-02541
    Event Type
    Injury
    Date Received
    November 19, 2018
    Date of Event
    October 1, 2002
    Report Date
    November 19, 2018
    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

    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. HILDICK-SMITH, D. J., KHAN, Z. I., SHAPIRO, L. M., & PETCH, M. C. (2002). OCCASIONAL-OPERATOR PERCUTANEOUS BRACHIAL CORONARY ANGIOGRAPHY: FIRST, DO NO ARM. CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, 57(2), 161-165. DOI:10.1002/CCD.10329 AS NOTED IN THE PUBLICATION HILDICK-SMITH ET AL OCCASIONAL-OPERATOR PERCUTANEOUSBRACHIALCORONARY ANGIOGRAPHY: FIRST, DO NO ARM; CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS 57:161¿165 (2002) ; A CORDIS SHEATH WAS USED DURING A PERCUTANEOUS BRACHIAL CORONARY ANGIOGRAPHY AND A LARGE BRACHIAL HEMATOMA REQUIRING SURGICAL EXPLORATION AND ARTERIAL REPAIR OCCURRED IN ONE PATIENT. 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 DEVICES FOR ANALYSIS OR PROCEDURAL FILMS, THE REPORTED CUSTOMER EVENT ¿HEMATOMA¿ COULD NOT BE CONFIRMED, AND THE EXACT ROOT CAUSE COULD NOT BE DETERMINED. A HEMATOMA IS A IS A COLLECTION OF BLOOD OUTSIDE OF A BLOOD VESSEL. ACCESS SITE BLEEDS ARE A COMMON PROCEDURAL COMPLICATION AND ARE FREQUENTLY RELATED TO STICK TECHNIQUE, ANTICOAGULATION, BLOOD PRESSURE AND/OR DISCOMFORT DURING AND AFTER THE PROCEDURE. PATIENT AND/OR PHARMACOLOGICAL FACTORS ARE ALSO LIKELY CONTRIBUTING FACTORS. COMPLICATIONS SUCH AS HEMATOMAS CAN ALSO BE MORE PREVALENT IN OBESE PATIENTS. 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. BASED ON THE LIMITED INFORMATION AVAILABLE FOR REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICES DESIGN OR 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 HILDICK-SMITH ET AL OCCASIONAL-OPERATOR PERCUTANEOUS BRACHIAL CORONARY ANGIOGRAPHY: FIRST, DO NO ARM; CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS 57:161¿165 (2002) ; A CORDIS SHEATH WAS USED DURING A PERCUTANEOUS BRACHIAL CORONARY ANGIOGRAPHY AND A LARGE BRACHIAL HEMATOMA REQUIRING SURGICAL EXPLORATION AND ARTERIAL REPAIR OCCURRED IN ONE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    924537 UNKNOWN CARDIOVASCULAR ACCESS DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE CORDIS CORPORATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening