BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CARDIOVASCULAR ACCESS

    MDR report key: 8074499 · Received November 15, 2018

    Report

    Report Number
    9616099-2018-02527
    Event Type
    Injury
    Date Received
    November 15, 2018
    Date of Event
    October 1, 2002
    Report Date
    November 15, 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 SPASM OCCURRED, TERMINATING THE PROCEDURE IN ONE PATIENT. AT THE END OF THE PROCEDURE, THE INTRODUCER SHEATH WAS REMOVED AND DIRECT DIGITAL PRESSURE WAS APPLIED TO THE BRACHIAL ARTERY FOR A MINIMUM OF 15 MIN IN ORDER TO ACHIEVE HEMOSTASIS. FOLLOWING THIS, A TOURNIQUET WAS APPLIED TO THE BRACHIAL ARTERY (TO A MODERATE TIGHTNESS, STILL PERMITTING PALPATION OF THE RADIAL PULSE) JUST ABOVE THE PUNCTURE SITE FOR A FURTHER HOUR. 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 ¿SPASM OF ARTERY¿ COULD NOT BE CONFIRMED AND THE EXACT ROOT CAUSE COULD NOT BE DETERMINED. VESSEL SPASM IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH ANY INTERVENTIONAL PROCEDURE WHERE DEVICES ARE INTRODUCED INTO THE VASCULATURE AND IS LISTED IN THE IFU (INSTRUCTIONS FOR USE) AS SUCH. LOCAL VASOSPASM CAN BE CAUSED BY THE DEVICE MANIPULATIONS INHERENT IN ANY PROCEDURE CAUSING ENDOTHELIAL IRRITATION. 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 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 SPASM OCCURRED, TERMINATING THE PROCEDURE IN ONE PATIENT. AT THE END OF THE PROCEDURE, THE INTRODUCER SHEATH WAS REMOVED AND DIRECT DIGITAL PRESSURE WAS APPLIED TO THE BRACHIAL ARTERY FOR A MINIMUM OF 15 MINUTES IN ORDER TO ACHIEVE HEMOSTASIS. FOLLOWING THIS, A TOURNIQUET WAS APPLIED TO THE BRACHIAL ARTERY (TO A MODERATE TIGHTNESS, STILL PERMITTING PALPATION OF THE RADIAL PULSE) JUST ABOVE THE PUNCTURE SITE FOR A FURTHER HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914134 UNKNOWN CARDIOVASCULAR ACCESS DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE CORDIS CORPORATION UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R