BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CARDIOVASCULAR ACCESS

    MDR report key: 8079088 · Received November 16, 2018

    Report

    Report Number
    9616099-2018-02533
    Event Type
    Injury
    Date Received
    November 16, 2018
    Date of Event
    October 1, 2002
    Report Date
    November 16, 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 REPORTED 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 BRACHIAL ARTERY DISSECTION WITHOUT CLINICAL SEQUELAE RESULTED IN TWO PATIENTS. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED. GIVEN THE LIMITED INFORMATION PROVIDED, AND WITHOUT THE RETURN OF THE DEVICES FOR ANALYSIS OR PROCEDURAL FILMS, THE REPORTED EVENT ¿ARTERY DISSECTION¿ COULD NOT BE CONFIRMED AND THE EXACT ROOT CAUSE COULD NOT BE DETERMINED. DISSECTION IS A WELL-KNOWN AND EXTENSIVELY DOCUMENTED POTENTIAL COMPLICATION OF THIS TYPE OF PROCEDURE AND IS LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS SUCH. THE PHYSICAL MANIPULATION INHERENT IN THE PERCUTANEOUS BRACHIAL CORONARY ANGIOGRAPHY PROCEDURE CAN DISRUPT THE VESSEL PLAQUE AND INTIMA. SEVERAL FACTORS CAN CONTRIBUTE TO A DISSECTION INCLUDING VESSEL CHARACTERISTICS SUCH AS CALCIFICATION AND TORTUOSITY AND PROCEDURAL FACTORS. 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 REPORTED 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 BRACHIAL ARTERY DISSECTION WITHOUT CLINICAL SEQUELAE RESULTED IN TWO PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920468 UNKNOWN CARDIOVASCULAR ACCESS DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE CORDIS CORPORATION UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening 18-GAUGE ARTERIAL NEEDLE (CORDIS OR COOK)| HEPARIN (5,000 I.U.)| UNKNOWN 30CM GUIDEWIRE