BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROPUNCTURE ACCESS SET

    MDR report key: 3143040 · Received May 23, 2013

    Report

    Report Number
    1820334-2013-00214
    Event Type
    Injury
    Date Received
    May 23, 2013
    Date of Event
    April 30, 2013
    Report Date
    May 1, 2013
    Manufacturer
    COOK, INC.
    Product Code
    DRE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LEAVING A DEVICE IN A PT IS NOT LABELED. SEPARATION IS NOT LABELED. EVENT EVAL: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2013, A (B)(6) MALE WITH A COMPLETE HEART BLOCK UNDERWENT PACEMAKER IMPLANTATION WITH EXTRATHORACIC PUNCTURE TECHNIQUES. ANGIOGRAPHY IN THE SUBCLAVIAN VEIN CONFIRMED NORMAL VESSEL FORM. THE WIRE GUIDE WAS INSERTED THROUGH THE PUNCTURE NEEDLE BUT RIGHT AFTER EXITING THE NEEDLE, THE WIRE SHOWED A SWIRLING-LIKE MOVEMENT WHICH EVENTUALLY PREVENTED THE WIRE GUIDE FROM ADVANCING AND THE WIRE TIP BECAME TANGLED. THE PHYSICIAN ATTEMPTED TO REMOVE THE WIRE GUIDE BUT THE TIP WAS CAUGHT ON THE NEEDLE TIP RESULTING IN ELONGATION OF THE WIRE. THE NEEDLE WAS REMOVED AND THE SHEATH WAS ADVANCED OVER THE WIRE GUIDE BUT THE SHEATH WOULD NOT BE ADVANCED INTO THE VESSEL. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE DEVICES, THE 1CM OF WIRE GUIDE TIP SEPARATED AND REMAINED IN FAT LAYER AND NOT REMOVED. ANOTHER MPIS PRODUCT WAS USED INSTEAD AND THE PROCEDURE WAS COMPLETED. UPDATE (B)(6) 2013: "THE PUNCTURE NEEDLE WAS REMOVED AND THE SHEATH WAS ADVANCED OVER THE WIRE GUIDE BUT THE SHEATH WOULD NOT BE ADVANCED INTO THE VESSEL. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE WHOLE THE DEVICES, THE 1CM OF WIRE GUIDE TIP BECAME SEPARATED AND REMAINED IN FAT LAYER." PT OUTCOME WAS NOT PROVIDED BY THE REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228537 MICROPUNCTURE ACCESS SET DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE COOK, INC. NA F3499062

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other