BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROPUNCTURE ACCESS SET

    MDR report key: 2800406 · Received October 16, 2012

    Report

    Report Number
    1820334-2012-00457
    Event Type
    Injury
    Date Received
    October 16, 2012
    Date of Event
    September 25, 2012
    Report Date
    September 26, 2012
    Manufacturer
    COOK, INC.
    Product Code
    DRE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXPIRATION DATE UNK AS LOT IS UNK. (B)(4). MANUFACTURING DATE IS UNK AS LOT IS UNK. NO PRODUCT WAS RETURNED TO ASSIST IN THIS INVESTIGATION. THIS DEVICE IS INSPECTED 100% FOR BENDS, KINKS, ADEQUATE JOINT STRENGTH AND OTHER SURFACE IMPERFECTIONS DURING THE MFG PROCESS AND AGAIN, PRIOR TO TRANSPORT. THIS DEVICE IS PROVIDED WITH AN ATTACHED CAUTION LABEL, IN WHICH WE ILLUSTRATE; "WITHDRAWAL AND/OR MANIPULATION OF THE DISTAL SPRING COIL PORTION OF THE WIRE GUIDE THROUGH THE NEEDLE TIP MAY RESULT IN BREAKAGE." WITHOUT AN INSPECTION OF THE COMPLAINT PRODUCT, A DEFINITE ROOT CAUSE CANNOT BE FOUND. IN PREVIOUS COMPLAINTS, WE HAVE FOUND POSSIBLE CAUSES TO INCLUDE DAMAGE TO THE WIRE GUIDE ASSOCIATED WITH WITHDRAWAL THROUGH THE NEEDLE (PER WARNING LABEL) OR OTHER INSTRUMENT. LESS FREQUENTLY, PT ANATOMY MAKES WITHDRAWAL OF THE WIRE GUIDE DIFFICULT RESULTING IN SEPARATION WHEN THE FORCE EXCEEDS DESIGN SPEC. THE EVENT DESCRIPTION DOES NOT EXPLICITLY STATE BUT APPEARS THAT THE WIRE WAS MANIPULATED AND REMOVED WHILE STILL IN THE NEEDLE. THE LOOPING WOULD NOT HAVE BEEN CAUSED BY THE NEEDLE BUT ONCE LOOPED AND WITHDRAWAL DIFFICULT THE BEVEL TIP OF THE NEEDLE CAN SEVER THE WIRE GUIDE. IN THE ABSENCE OF ANY DETAIL CONCERNING THIS COMPLAINT THE ROOT CAUSE CANNOT BE DETERMINED. ROOT CAUSE IS INCONCLUSIVE. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. INSUFFICIENT RISK PER QUALITY ENGINEERING RISK ANALYSIS.

    Description of Event or Problem · 1

    A (B)(6) MALE UNDERWENT ABLATION ON (B)(6) 2012. THE USER PUNCTURED THE LEFT SUBCLAVIAN VEIN WITH THE SUPPLIED NEEDLE AND INSERTED THE SUPPLIED WIRE GUIDE, BUT COULD NOT ADVANCE WELL. THE USER MOVED THE WIRE GUIDE BACK AND FORTH TO ADVANCE, AND THE WIRE GUIDE TIP BECAME LOOPED. HE PULLED THE WIRE GUIDE TO REMOVE AND FELT RESISTANCE, BUT KEPT REMOVING AND FOUND THAT APPROX 2CM OF THE TIP WAS MISSING. HE FOUND THE MISSING TIP NEAR THE PUNCTURED SITE AND ATTEMPTED TO REMOVE IT WITH SNARE CATHETER. HOWEVER, THE TIP WAS ACTUALLY IN BETWEEN THE PUNCTURE SITE AND THE VESSEL, SO HE MADE AN INCISION IN THE PUNCTURED SITE AND SUCCESSFULLY REMOVED THE TIP. THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention