BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET

    MDR report key: 2250940 · Received September 9, 2011

    Report

    Report Number
    1820334-2011-00492
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    June 9, 2011
    Report Date
    August 11, 2011
    Manufacturer
    COOK, INC.
    Product Code
    DRE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO PRODUCT WAS RETURNED TO ASSIST IN THIS INVESTIGATION. THIS DEVICE IS INSPECTED 100% FOR BENDS, KINKS, ADEQUATE JOINT STRENGTH AND OTHER SURFACE IMPERFECTIONS PRIOR TO TRANSPORT. IN ADDITION EACH PMG WIRE GUIDE COMES WITH AN ATTACHED CAUTION LABEL, WHICH ILLUSTRATES; "WITHDRAWAL AND/OR MANIPULATION OF THE DISTAL SPRING COIL PORTION OF THE WIRE GUIDE THROUGH THE NEEDLE TIP MAY RESULT IN BREAKAGE." WITHOUT THE COMPLAINT DEVICE WE CANNOT MAKE A CONCLUSIVE ROOT CAUSE ANALYSIS. WHEN WE HAVE SEEN THIS TYPE OF DEVICE FAILURE IN THE PAST, IT HAS GENERALLY BEEN ASSOCIATED WITH THE WIRE GUIDE BEING DAMAGED BY WITHDRAWAL THROUGH THE NEEDLE OR OTHER INSTRUMENT. LESS FREQUENTLY, PATIENT ANATOMY MAKES WITHDRAWAL OF THE WIRE GUIDE DIFFICULT RESULTING IN SEPARATION WHEN THE FORCE EXCEEDS DESIGN SPECIFICATION. THE EVENT DESCRIPTION STATES "...THE NEEDLE DID NOT PASS APPROPRIATELY THROUGH. IT WENT IN AT A BENT ANGLE AND A PORTION OF THE WIRE WAS SHEARED OFF" SUGGESTING THE DEVICE FAILURE WAS THE RESULT OF USER TECHNIQUE. THE ROOT CAUSE WILL BE STATED AS "USER TECHNIQUE". WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. INSUFFICIENT RISK PER QUALITY ENGINEERING RISK ASSESSMENT.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS USING THE MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET TO GAIN ACCESS IN THE GROIN. THE WIRE WAS PUT THROUGH THE PROVIDED NEEDLE, THE NEEDLE WAS REMOVED AND THE DILATOR WAS ADVANCED OVER THE WIRE. AT THIS POINT PART OF THE WIRE SHEARED OFF AND WAS LEFT IN THE PATIENT. THE SHEARED OFF PORTION WAS RETRIEVED AND NO HARM WAS DONE TO THE PATIENT. PER THE MEDWATCH USER FACILITY REPORT #: (B)(4) RECEIVED ON 09/01/2011: WHEN THE MICROPUNCTURE WIRE WAS INSERTED DURING DUAL CHAMBER IMPLANTABLE CARDIAC DEFIBRILLATORS IMPLANTATION INTO THE SUBCLAVIAN VESSEL OF THE PATIENT, THE NEEDLE DID NOT PASS APPROPRIATELY THROUGH. IT WENT IN AT A BENT ANGLE AND A PORTION OF THE WIRE WAS SHEARED OFF. THE PHYSICIAN WAS ABLE TO REMOVE THE SHEARED PIECE FROM WITHIN THE VESSEL WITHOUT HARM TO THE PATIENT. THE SHEARED OFF PORTION OF THE WIRE WAS RETRIEVED WITH NO FURTHER REQUIREMENTS. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION DRE COOK, INC. NA 2698780

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention