BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIORITY ONE AC

    MDR report key: 19581991 · Received June 21, 2024

    Report

    Report Number
    2243441-2024-00019
    Event Type
    Injury
    Date Received
    June 21, 2024
    Date of Event
    May 23, 2024
    Report Date
    June 21, 2024
    Manufacturer
    TERUMO CLINICAL SUPPLY CO., LTD.
    Product Code
    QEZ
    UDI-DI
    04987350779373
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED INJURY TO A PATIENT IN THE CATHETERIZATION LAB FOR A NON-STEMI, WHERE AN ATTEMPT WAS MADE TO ASPIRATE A CLOT. USING A RIGHT RADIAL APPROACH WITH A 6F GUIDE EBU, A PERCUTANEOUS CORONARY INTERVENTION (PCI) WITH A 2.5MM BALLOON WAS PERFORMED. THE PRIORITY ONE CATHETER CROSSED, AND THE CLOT WAS ASPIRATED. HOWEVER, AS THE CATHETER WAS BEING WITHDRAWN FROM THE THIRD DIAGONAL, RESISTANCE WAS ENCOUNTERED, AND ADDITIONAL FORCE USED TO REMOVE IT CAUSED THE TIP ON P1 TO DISLODGE AND REMAIN INSIDE THE CORONARY ARTERY. THE PATIENT WAS STABLE BUT WAS TRANSFERRED TO THE FOR FURTHER INTERVENTION, WHICH WAS NOT PERFORMED AS THE PATIENT REMAINED STABLE. THE PROCEDURE CONDUCTED WAS A HEART CATHETERIZATION, WITH NO BLOOD LOSS REPORTED. THE PATIENT HAS A HISTORY OF CHEST PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1183759 PRIORITY ONE AC ASPIRATION THROMBECTOMY CATHETER QEZ TERUMO CLINICAL SUPPLY CO., LTD. N/A 231031Y 04987350779373

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other .014 MANMO WIRE BSC| 2.5MM PCI BALLOON| 6F GLIDE SHEATH| 6F MEDTRONIC WBU CORONARY GUIDE CATH