BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER

    MDR report key: 8262259 · Received January 18, 2019

    Report

    Report Number
    1820334-2019-00122
    Event Type
    Malfunction
    Date Received
    January 18, 2019
    Date of Event
    January 9, 2019
    Report Date
    April 16, 2019
    Manufacturer
    COOK INC
    Product Code
    DQO
    UDI-DI
    00827002093126
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. INVESTIGATION ¿ EVALUATION. REVIEWS OF THE DIMENSIONAL VERIFICATION, COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), MANUFACTURER¿S INSTRUCTIONS, QUALITY CONTROL, AND A FUNCTIONAL TEST & VISUAL INSPECTION OF THE RETURNED DEVICE AS WELL AS AN INSPECTION OF UNUSED PRODUCT WERE CONDUCTED DURING THE INVESTIGATION. THE VISUAL INSPECTION OF THE RETURNED PACKAGE CONFIRMED THAT ONE UNOPENED HNBR CATHETER WAS RETURNED FOR INVESTIGATION. THERE WERE NO DEFECTS NOTED ON THE DEVICE PACKAGING. UPON OPENING THE POUCH, NO DEFECTS OR DAMAGE WAS NOTED ON THE CATHETER. DURING THE FUNCTIONAL TEST, A .032¿ WIRE GUIDE WAS PASSED ALL THE WAY THROUGH THE LUMEN OF THE CATHETER WITH NO ISSUES, INDICATING THERE WERE NO OBSTRUCTIONS. THE LENGTH OF THE CATHETER WAS MEASURED WITHIN SPECIFICATIONS. INVESTIGATION WAS UNABLE TO RECREATE THE REPORTED FAILURE MODE ON THIS UNOPENED DEVICE. ADDITIONALLY, 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 SHOWED NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. IT SHOULD ALSO BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. FURTHERMORE, REVIEWS OF THE MANUFACTURES INSTRUCTIONS AND QUALITY CONTROL PROCEDURES WERE CONDUCTED, AND NO GAPS WERE DISCOVERED. THROUGH THIS REVIEW, COOK HAS CONCLUDED THAT APPROPRIATE CONTROLS ARE IN PLACE TO PREVENT THIS REPORTED FAILURE MODE. MOREOVER, AN IFU IS PROVIDED WITH THE DEVICE WHICH SPEAKS FOR THE REPORTED FAILURE MODE. IN THE PRECAUTIONS, IT STATES ¿IF RESISTANCE IS ENCOUNTERED DURING MANIPULATION, STOP AND DETERMINE THE CAUSE BEFORE PROCEEDING ANY FURTHER.¿ THEN LATER IN THE INSTRUCTIONS SECTION, IT NOTES ¿FLUSH THE DEVICE PRIOR TO USE. UNDER FLUOROSCOPIC GUIDANCE, ADVANCE THE CATHETER OVER AN APPROPRIATELY SIZED WIRE GUIDE OR THROUGH AN APPROPRIATELY SIZED SHEATH INTRODUCER TO THE INTENDED LOCATION. NOTE: IF RESISTANCE IS ENCOUNTERED DURING MANIPULATION, STOP AND DETERMINE THE CAUSE BEFORE PROCEEDING ANY FURTHER.¿ BASED ON THE INFORMATION PROVIDED AND THE EXAMINATION OF THE RETURNED PRODUCT, INVESTIGATION HAS CONCLUDED THAT THIS EVENT CAN BE TRACED TO A ONE-OFF COMPONENT FAILURE WITHOUT ANY DESIGN OR MANUFACTURING ISSUE. 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

    PMA/510(K) NUMBER: K173289. 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 THAT DURING AN EMBOLIZATION PROCEDURE FOR GASTROINTESTINAL BLEEDING, THE HUB OF A BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER SEPARATED FROM THE DEVICE. THE HUB WAS REPORTED TO SEPARATE WHILE THE DEVICE WAS BEING ADVANCED ONTO ANOTHER MANUFACTURER'S 0.035 GUIDE WIRE WITH LITTLE FORCE. THE DEVICE DID NOT MAKE PATIENT CONTACT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER UNKNOWN CATHETER. 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
    54215 BEACON TIP TORCON NB ADVANTAGE ANGIOGRAPHIC CATHETER DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO COOK INC G09312 9033467 00827002093126

    Patients

    Seq Age Sex Outcome Treatment
    1 TERUMO GLIDEWIRE 0.035