BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET

    MDR report key: 9539643 · Received January 2, 2020

    Report

    Report Number
    1820334-2020-00041
    Event Type
    Malfunction
    Date Received
    January 2, 2020
    Report Date
    January 2, 2020
    Manufacturer
    COOK INC
    Product Code
    DYB
    UDI-DI
    00827002480032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: INVESTIGATION ¿ EVALUATION. REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, DRAWING, MANUFACTURER¿S INSTRUCTIONS, QUALITY CONTROL PROCEDURES, SPECIFICATIONS, AND A VISUAL INSPECTION OF THE RETURNED DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE VISUAL INSPECTION OF THE RETURNED PACKAGE CONFIRMED THAT ONE MPIS INTRODUCER WAS PROVIDED FOR INVESTIGATION. THE INNER AND OUTER CATHETERS WERE RETURNED ASSEMBLED. THE OUTER CATHETER WAS SEPARATED AT 3.4CM FROM THE FITTING LEAVING 6.4CM OF THE DISTAL END. BOTH SEPARATED ENDS SHOWED SIGNS OF ELONGATION AND MATERIAL STRESS. 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. REVIEWS OF THE MANUFACTURER¿S INSTRUCTIONS, DRAWINGS, SPECIFICATIONS, AND QUALITY CONTROL PROCEDURES WERE CONDUCTED, AND NO GAPS WERE DISCOVERED. BASED ON THE INFORMATION PROVIDED AND THE EXAMINATION OF THE RETURNED PRODUCT, INVESTIGATION HAS CONCLUDED THE POTENTIAL CAUSE CAN BE TRACED TO PATIENT CONDITION, AS IT WAS STATED THAT THE PATIENT¿S ANATOMY WAS SCARRED WHICH COULD HAVE BEEN A CONTRIBUTING FACTOR THAT RESULTED IN THE REPORTED FAILURE MODE. 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

    ADDITIONAL INFORMATION WAS RECEIVED NOTING THAT THE PROCEDURE BEING PERFORMED WAS A ANGIOGRAM WITH FEMORAL ACCESS. REPORTEDLY, THE ACCESS SITE PRESENTED WITH SCAR TISSUE, AND RESISTANCE WAS NOTED. HOWEVER, NO SECTION OF THE DEVICE REMAINED IN THE PATIENT, NO ADDITIONAL INTERVENTIONS WERE NEEDED, NO KINKS WERE NOTED, AND NO HEMOSTATIC VALVE WAS ATTACHED. ACCORDING TO THE INITIAL REPORTER, IT WAS THE OUTER CANNULA THAT SEPARATED DURING THE INSERTION OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    OCCUPATION = UNKNOWN. PMA/510(K) NUMBER = K171275. 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 AN UNKNOWN PROCEDURE, A MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET CATHETER SEPARATED IN THE MIDDLE OF THE DEVICE. THE DEVICE WAS REPORTEDLY INTACT UPON REMOVAL FROM THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3382 MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET DYB INTRODUCER, CATHETER DYB COOK INC G48003 10096244 00827002480032

    Patients

    Seq Age Sex Outcome Treatment
    1