BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROPUNCTURE TRANSITIONLESS ACCESS SET

    MDR report key: 8856990 · Received August 2, 2019

    Report

    Report Number
    1820334-2019-01930
    Event Type
    Injury
    Date Received
    August 2, 2019
    Date of Event
    July 17, 2019
    Report Date
    August 2, 2019
    Manufacturer
    COOK INC
    Product Code
    DYB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K) NUMBER: K171275. INVESTIGATION, EVALUATION. REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, MANUFACTURER¿S INSTRUCTIONS, AND QUALITY CONTROL PROCEDURES 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. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; ACCORDINGLY, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. FURTHERMORE, REVIEWS OF THE MANUFACTURER¿S INSTRUCTIONS, DRAWINGS, LABELING, AND QUALITY CONTROL PROCEDURES WERE CONDUCTED, AND NO GAPS WERE DISCOVERED. IT SHOULD BE NOTED THAT THE LABELING FOR THIS DEVICE DOES PROVIDE A WARNING TO NOT PULL THE DISTAL SPRING COIL PORTION OF THE WIRE GUIDE THROUGH THE NEEDLE TIP. BASED ON THE INFORMATION PROVIDED AND NO PRODUCT RETURNED, INVESTIGATION HAS CONCLUDED THE POTENTIAL CAUSE CAN BE TRACED TO THE PROCEDURE AS IT WAS STATED THAT THE WIRE WAS REMOVED THROUGH THE NEEDLE, PER THE INCLUDED LABELING THIS ACTION IS KNOWN TO A RESULT IN THE REPORTED FAILURE MODE. WE WILL CONTINUE OUR MONITORING OF SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE PERSONNEL OF THIS EVENT. MEASURES ARE BEING CONDUCTED TO ADDRESS THIS FAILURE MODE. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    AS REPORTED, AFTER GAINING ACCESS IN THE RIGHT FEMORAL ARTERY FOR AN UNKNOWN PROCEDURE, THE TIP OF THE WIRE INCLUDED IN A MICROPUNCTURE TRANSITIONLESS ACCESS SET SEPARATED UPON REMOVING THE WIRE THROUGH THE NEEDLE. THE SEPARATED PORTION WAS LEFT IN THE PATIENT'S TISSUE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. 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
    650202 MICROPUNCTURE TRANSITIONLESS ACCESS SET DYB INTRODUCER, CATHETER DYB COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other