BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RING TRANSJUGULAR INTRAHEPATIC ACCESS SET

    MDR report key: 9329928 · Received November 15, 2019

    Report

    Report Number
    1820334-2019-02900
    Event Type
    Malfunction
    Date Received
    November 15, 2019
    Date of Event
    November 1, 2019
    Report Date
    January 7, 2020
    Manufacturer
    COOK INC
    Product Code
    DYB
    UDI-DI
    00827002065413
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A2: PATIENT WAS BORN IN 1942. D10: PRODUCT RECEIVED ON: 06NOV2019. INVESTIGATION-EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL, AS WELL AS A VISUAL INSPECTION WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS RETURNED IN A USED AND DAMAGED CONDITION WITH THE RM NEEDLE PARTIALLY INSERTED WITHIN THE TRT CATHETER. BIOLOGICAL MATTER IS PRESENT THROUGHOUT THE DEVICE. A HOLE IS VISIBLE ON THE CATHETER ALONG THE INSIDE OF THE CURVE, 37.8CM DISTAL TO THE HUB. ALONG THE HOLE IS A FLAP OF TUBING MATERIAL THAT IS NOT LARGE ENOUGH TO COVER THE HOLE. IT APPEARS THAT THE HOLE WAS CREATED BY A PUNCTURE FROM THE INSIDE OF THE CATHETER, LIKELY FROM THE NEEDLE. THERE IS A SMALL 1MM LONG LONGITUDINAL SPLIT AT THE DISTAL END OF THE CATHETER. THE NEEDLE IS A LITTLE BENT, BUT STILL WITHIN SPECIFICATION FOR CURVE SHAPE. WHEN ADVANCING THE NEEDLE THROUGH THE CATHETER, THE NEEDLE TENDS TO CATCH ON THE HOLE. THERE DOES NOT APPEAR TO BE ANY VISIBLE DAMAGE, SCRATCHES, OR SPURS AT THE DISTAL END OF THE NEEDLE. ALL RELEVANT DIMENSIONS SUCH AS CATHETER INNER DIAMETER, NEEDLE OUTER DIAMETER, AND NEEDLE REVERSED BEVEL LENGTH WERE CONFIRMED TO BE WITHIN SPECIFICATION. ADDITIONALLY, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. SUFFICIENT CONTROLS ARE IN PLACE TO DETECT THIS FAILURE MODE PRIOR TO RELEASE AND THE RISKS OF THIS DEVICE ARE ACCEPTABLE WHEN WEIGHED AGAINST THE BENEFITS. THE DEVICE HISTORY RECORD FOR THE LOT PROVIDED SHOWED NO NONCONFORMANCES. RELATED NEEDLE SUBASSEMBLY LOTS AND CATHETER SUBASSEMBLY LOT SHOWED NO NONCONFORMANCES. A DATABASE SEARCH REVEALED ONE OTHER COMPLAINT FROM THIS LOT AT TIME OF INVESTIGATION, WHICH WAS OPENED TO TREND THE DISTAL TIP DAMAGE ON THE SAME DEVICE . SINCE THERE ARE NO NONCONFORMANCES OR OTHER COMPLAINTS FOR SAME FAILURE MODE FOR THIS LOT, THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN THE FIELD. THE DEVICE IS SHIPPED WITH INSTRUCTION FOR USE (IFU). THE PRODUCT IFU STATES THE FOLLOWING IN CONSIDERATION OF THE REPORTED FAILURE MODE: INTENDED USE: THE RING TRANSJUGULAR INTRAHEPATIC ACCESS SET IS INTENDED FOR TRANSJUGULAR LIVER ACCESS IN DIAGNOSTIC AND INTERVENTIONAL PROCEDURES. PRECAUTIONS: BEFORE INTRODUCTION AND PERIODICALLY DURING THE PROCEDURE, THE TRANSJUGULAR INTRODUCER SHEATH SHOULD BE FLUSHED WITH SALINE. HOW SUPPLIED: UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED. IT IS POSSIBLE THAT USE ERROR CONTRIBUTED TO THE FAILURE. BASED ON THE SHAPE OF THE HOLE, THE USER MAY HAVE ACCIDENTALLY PUNCTURED THE TUBING OF THE CATHETER WITH THE NEEDLE. THE CUSTOMER ALSO REPORTED THAT THIS FAILURE OCCURRED PRIOR TO USE IN THE PATIENT, BUT THERE WAS BIOLOGICAL MATTER PRESENT THROUGHOUT THE DEVICE SO DAMAGED INCURRED DURING USE CANNOT BE RULED OUT. RELATED TO THIS, THE DEVICE WAS REPORTED TO BE USED TO GAIN RIGHT FEMORAL ACCESS FOR A AAA ENDOLEAK PROCEDURE. PER THE IFU THIS DEVICE IS INTENDED FOR TRANSJUGULAR LIVER ACCESS, SO IT MAY HAVE BEEN EXPOSED TO AND / OR DAMAGED BY CONDITIONS IT WAS NOT DESIGNED FOR. BASED ON THE INFORMATION PROVIDED, INSPECTION OF THE RETURNED PRODUCT, AND THE RESULTS OF THE INVESTIGATION, A DEFINITIVE CAUSE COULD NOT BE DETERMINED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, 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: UNKNOWN. PMA/510(K) #: K171820. 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 RING TRANSJUGULAR INTRAHEPATIC ACCESS SET WAS USED IN A FEMALE PATIENT FOR A ENDOLUMINAL GRAFT ABDOMINAL AORTIC ANEURYSM ENDOLEAK REPAIR PROCEDURE. THE OPERATOR NOTICED A HOLE ON THE TEFLON CATHETER "A COUPLE CENTIMETERS FROM THE TIP". THE TIP OF THE CATHETER HAD "A LITTLE PIECE SHEER-OFF" OUTSIDE OF THE PATIENT, AND THE PHYSICIAN "CLIPPED OFF THE PIECE". A NEW, 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
    1122209 RING TRANSJUGULAR INTRAHEPATIC ACCESS SET DYB INTRODUCER, CATHETER DYB COOK INC N/A 9393065 00827002065413

    Patients

    Seq Age Sex Outcome Treatment
    1