BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET

    MDR report key: 9812291 · Received March 10, 2020

    Report

    Report Number
    1820334-2020-00583
    Event Type
    Malfunction
    Date Received
    March 10, 2020
    Date of Event
    February 26, 2020
    Report Date
    April 16, 2020
    Manufacturer
    COOK INC
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORT. IT WAS REPORTED THAT THE WIRE OF A MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET UNRAVELED IN A PATIENT DURING REMOVAL. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED. ADDITIONAL INFORMATION REGARDING THE PATIENT, DEVICE AND EVENT HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE. INVESTIGATION - EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DRAWING, 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 PROVIDED PHOTO SHOWS AN UNRAVELED WIRE. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. THE EVIDENCE INDICATES THE PRODUCT WAS MADE TO SPECIFICATIONS. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; ACCORDINGLY, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. REVIEWS OF THE MANUFACTURER¿S INSTRUCTIONS, DRAWINGS, AND QUALITY CONTROL PROCEDURES WERE CONDUCTED, AND NO GAPS WERE DISCOVERED. AN IFU IS PROVIDED WITH THIS DEVICE, WHICH STATES ¿WHEN INSERTING, MANIPULATING OR WITHDRAWING A DEVICE THROUGH AN INTRODUCER, ALWAYS MAINTAIN INTRODUCER POSITION. DO NOT ATTEMPT TO INSERT OR WITHDRAW THE WIRE GUIDE AND/OR INTRODUCER IF RESISTANCE IS FELT.¿ THE IFU GOES ON TO WARN ¿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, THE CONCLUSION DRAWN IS THE POTENTIAL CAUSE CAN BE TRACED TO THE PROCEDURE AS RESISTANCE WAS FELT WHEN REMOVING THE WIRE WHILE IT WAS THROUGH THE NEEDLE WHICH AS SHOWN IN THE INCLUDED LABEL AND INSTRUCTIONS FOR USE. 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. 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

    OCCUPATION: MANAGER. PMA/510(K) #: 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

    IT WAS REPORTED THAT THE WIRE OF A MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET UNRAVELED IN A PATIENT DURING REMOVAL. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED. ADDITIONAL INFORMATION REGARDING THE PATIENT, DEVICE AND EVENT HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273535 MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET DYB INTRODUCER, CATHETER DYB COOK INC N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1