BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIVER ACCESS AND BIOPSY SET

    MDR report key: 10207194 · Received June 29, 2020

    Report

    Report Number
    1820334-2020-01214
    Event Type
    Malfunction
    Date Received
    June 29, 2020
    Date of Event
    May 28, 2020
    Report Date
    July 27, 2020
    Manufacturer
    COOK INC
    Product Code
    DYB
    UDI-DI
    00827002507791
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THIS REPORT IS BEING SENT TO INDICATE THE COMPLAINT EVENT IS NOT REPORTABLE. UPON FURTHER INVESTIGATION AND EXAMINATION OF THE RETURNED PRODUCT, THIS EVENT IS NOT REPORTABLE. THERE IS NO INFORMATION CONFIRMING DEVICE MALFUNCTION OR SERIOUS INJURY. REPLACEMENT OF DEVICE TO COMPLETE PROCEDURE IS NEGLIGIBLE HARM AND DOES NOT MEET THE CRITERIA FOR A REPORTABLE EVENT. A REVIEW OF RISK DOCUMENTATION DOES NOT INDICATE THAT THIS EVENT IS LIKELY TO CAUSE SERIOUS INJURY IF IT WERE TO REOCCUR. AS THERE ARE NO RECORDED INCIDENCES OF SERIOUS INJURY DUE TO THE COMPLAINT EVENT, AND IT IS NOT LIKELY THAT SERIOUS INJURY WOULD RESULT IF THE EVENT WERE TO RECUR, PER 21CFR PART 803.50 THE COMPLAINT EVENT IS CONSIDERED NOT REPORTABLE. 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

    CONCOMITANT MEDICAL PRODUCTS: CONCOMITANT MEDICAL PRODUCTS: SUPER STIFF AMPLATZ WIRE 0.035". PMA/510(K) #: K171853. 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

    IT WAS REPORTED A (B)(6) OLD FEMALE PATIENT REQUIRED THE USE OF A LIVER ACCESS AND BIOPSY SET FOR A LIVER BIOPSY AND HEPATIC VENOUS PRESSURE GRADIENT MEASUREMENT AND TRANSJUGULAR LIVER BIOPSY. THE OPERATOR NOTED THERE WAS RESISTANCE WHEN ADVANCING THE SHEATH AND DILATOR OVER THE GUIDEWIRE. THE SHEATH AND DILATOR WERE REMOVED, AND IT WAS NOTED THAT "THE TIP OF THE SHEATH HAD FRAYED." ANOTHER SIMILAR DEVICE WAS USED TO COMPLETE THE PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671165 LIVER ACCESS AND BIOPSY SET DYB INTRODUCER, CATHETER DYB COOK INC N/A 9627175 00827002507791

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR