BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROPUNCTURE ACCESS SET

    MDR report key: 2112345 · Received May 25, 2011

    Report

    Report Number
    1820334-2011-00258
    Event Type
    Injury
    Date Received
    May 25, 2011
    Date of Event
    April 22, 2011
    Report Date
    April 28, 2011
    Manufacturer
    COOK, INC.
    Product Code
    DRE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT WAS RETURNED IN A USED AND DAMAGED CONDITION. THE SEPARATED TIP WAS NOT RETURNED. THIS DEVICE IS INSPECTED 100% FOR BENDS, KINKS, ADEQUATE JOINT STRENGTH AND OTHER SURFACE IMPERFECTIONS PRIOR TO TRANSPORT. ADDITIONAL COMMENTS: PER THE ATTACHED CAUTION LABEL, WE ILLUSTRATE; "WITHDRAWAL AND/OR MANIPULATION OF THE DISTAL SPRING COIL PORTION OF THE WIRE GUIDE THROUGH THE NEEDLE TIP MAY RESULT IN BREAKAGE." AN EXAMINATION OF THE RETURNED DEVICE VERIFIES THE SEPARATION OF THE WIRE GUIDE. THE REASONS FOR THIS TYPE OF DEVICE FAILURE ARE TYPICALLY; DIFFICULTY WITHDRAWING THE DEVICE OR THE WIRE GUIDE IS DAMAGED THROUGH CONTACT WITH THE NEEDLE OR OTHER INSTRUMENT. A TORTUROUS ANATOMY COULD ALSO RESULT IN EXCESS FORCE BEING REQUIRED TO WITHDRAW THE WIRE GUIDE CAUSING THE DAMAGE SEEN ON THIS DEVICE. AT THIS TIME WE CANNOT DETERMINE WITH ANY DEGREE OF CERTAINTY WHY THIS FAILURE OCCURRED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. NO ACTION REQUIRED PER INSUFFICIENT RISK.

    Description of Event or Problem · 1

    ON (B)(6) 2011, MICROPUNCTURE ACCESS SET WAS USED FOR OUTER LAYER OF THE SUBCLAVIAN VEIN. THE WIRE GUIDE WAS INSERTED INTO THE VESSEL THROUGH THE NEEDLE PUNCTURED. WHEN THE PHYSICIAN WAS OPERATING THE WIRE GUIDE, HE FELT STRONG RESISTANCE AND AGGRESSIVELY PULLED IT. THE WIRE GUIDE TIP GOT STUCK IN THE SUBCLAVIAN VEIN AND BECAME UNRAVELLED, AND THEN SEPARATED. ANOTHER MANUFACTURER'S DEVICE WAS USED TO COMPLETE THE PROCEDURE. APPROX 2 MM OF WIRE GUIDE REMAINED IN THE SUBCLAVIAN VEIN BUT THE PHYSICIAN DECIDED TO TAKE A WAIT AND SEE APPROACH. AS OF (B)(6) 2011, THE WIRE GUIDE TIP STILL REMAINED IN THE VESSEL AND THE PHYSICIAN IS FOLLOWING THE PT CLOSELY. THE PT'S CONDITION IS UNK AS NOT PROVIDED BY RPTR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROPUNCTURE ACCESS SET DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE COOK, INC. NA F2506064

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Other