BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROPUNCTURE TRANSITIONLESS ACCESS SET

    MDR report key: 8803000 · Received July 18, 2019

    Report

    Report Number
    1820334-2019-01727
    Event Type
    Injury
    Date Received
    July 18, 2019
    Date of Event
    June 27, 2019
    Report Date
    August 30, 2019
    Manufacturer
    COOK INC
    Product Code
    DYB
    UDI-DI
    00827002363335
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION/EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), MANUFACTURER¿S INSTRUCTIONS, AND QUALITY CONTROL PROCEDURES OF THE DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD SHOWS NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. IT SHOULD BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. FURTHERMORE, REVIEWS OF THE MANUFACTURER¿S INSTRUCTIONS AND QUALITY CONTROL PROCEDURES WERE CONDUCTED, AND NO GAPS WERE DISCOVERED. BASED ON THE INFORMATION PROVIDED AND NO PRODUCT RETURNED, INVESTIGATION HAS CONCLUDED THAT THIS EVENT CAN BE TRACED TO THE USER AND UNINTENDED USE ERROR. REPORTEDLY, THE USER ATTEMPTED TO WITHDRAW THE WIRE THROUGH THE NEEDLE WHEN IT SEPARATED. THE PRODUCT IS PACKAGED WITH A DRAWING, WARNING THE USER AGAINST REMOVAL OF THE WIRE GUIDE THROUGH A NEEDLE. WE WILL CONTINUE OUR MONITORING OF SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE PERSONNEL OF THIS EVENT. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    OCCUPATION: RISK MANAGEMENT. PMA/510(K) NUMBER: K171275. (B)(4). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED, DURING A PROCEDURE TO PLACE AN INTERNAL CARDIAC DEFIBRILLATOR INVOLVING A (B)(6) YEAR-OLD FEMALE PATIENT, THE WIRE INCLUDED IN A MICROPUNCTURE TRANSITIONLESS ACCESS SET SEPARATED AND WAS LEFT IN THE PATIENT'S SOFT TISSUE. THE DEVICE WAS INTENDED TO BE USED TO FACILITATE PLACEMENT OF A LARGER WIRE. REPORTEDLY, AS THE USER ATTEMPTED TO PLACE THE WIRE INTO THE AXILLARY VEIN, WHICH WAS THE SECOND ACCESS POINT USED IN THE PROCEDURE, THE WIRE DID NOT THREAD THROUGH THE NEEDLE EASILY. THE ACCESS SITE WAS REPORTEDLY NORMAL, WITHOUT CALCIFICATION OR SCARRING. WHEN THE USER ATTEMPTED TO PULL THE WIRE BACK THROUGH THE NEEDLE, IT SHEARED. A DEEP "BLUNT DISSECTION" WAS USED TO APPROACH THE DISTAL TIP OF THE WIRE; HOWEVER, WAS NOT SUCCESSFUL. THE WIRE REPORTEDLY "BEGAN TO DETERIORATE" WITH TRACTION AND THE SHEARED PORTION OF THE DISTAL TIP OF THE DEVICE WAS RETAINED IN THE LEFT PECTORAL SOFT TISSUE. A VENOGRAM DEMONSTRATED A NOTABLE DISTANCE BETWEEN THE SEPARATED PORTION OF THE WIRE AND THE PATIENT'S VEIN, CONFIRMING THAT THE MATERIAL WAS OUTSIDE OF THE VASCULATURE. SUBSEQUENT ATTEMPTS WERE MADE TO ACCESS THE AXILLARY VEIN; HOWEVER, AFTER MULTIPLE STICKS ABOVE AND BELOW THE FIRST ACCESS POINT, THE USER MADE THE DECISION TO DOUBLE WIRE THE INITIAL ACCESS POINT DUE TO A SUGGESTED VASCULAR ANOMALY. HEMOSTASIS WAS MAINTAINED AND THE PROCEDURE WAS FINISHED. THE PATIENT REPORTEDLY LEFT THE OPERATING ROOM IN GOOD CONDITION. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598544 MICROPUNCTURE TRANSITIONLESS ACCESS SET DYB INTRODUCER, CATHETER DYB COOK INC G36333 9702392 00827002363335

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other| R