BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROPUNCTURE INTRODUCER SET 4 FR

    MDR report key: 1202365 · Received October 14, 2008

    Report

    Report Number
    MW5008668
    Event Type
    Injury
    Date Received
    October 14, 2008
    Date of Event
    October 2, 2008
    Report Date
    October 14, 2008
    Manufacturer
    COOK INC.
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT WAS TAKEN TO THE CATH LAB FOR IVC FILTER PLACEMENT. USING COOK MICROPUNCTURE KIT TO ACCESS CFV, MET SOME RESISTANCE SO WIRE PULLED BACK ALONG THE NEEDLE. DESPITE REMOVAL IN CONCERT, THE ENTIRE END OF THE WIRE UNRAVELED AND BROKE. ATTEMPTED TO REMOVE PIECE OF BROKEN WIRE BUT UNABLE. COMPLETED PROCEDURE UNEVENTFULLY. PT WAS SCHEDULED TO GO TO THE OR AFTER FILTER PLACEMENT, SO PERFORMED A RIGHT GROIN INCISION TO REMOVE WIRE FROM CFV UNDER DIRECT VISUALIZATION. POST-OP FILM STILL SHOWED SOME RETAINED WIRE, SO CT OBTAINED WHICH SHOWED A PIECE IN THE WALL OF THE GSV JUNCTION. THE FOLLOWING DAY DURING SCHEDULED WASHOUT OF FASCIOTOMIES, OPENED RIGHT GROIN INCISION AND DISSECTED OUT THE CFV AND GSV JUNCTION TO FIND PIECE OF WIRE ON THE POSTERIOR-MEDIAL SURFACE. ABLE TO REMOVE WITHOUT LIGATION OF THE GSV. NEW FILM TO DOCUMENT NO WIRE FRAGS LEFT BEHIND. ORIGINAL WIRE WAS KEPT AND THE CATH LAB FILED A MSD REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROPUNCTURE INTRODUCER SET 4 FR MICROPUNCTURE KIT DYB COOK INC. MPIS-405 F2233812

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| S