BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET

    MDR report key: 7420803 · Received April 11, 2018

    Report

    Report Number
    1820334-2018-00832
    Event Type
    Injury
    Date Received
    April 11, 2018
    Date of Event
    March 13, 2018
    Report Date
    May 18, 2018
    Manufacturer
    COOK INC
    Product Code
    DYB
    UDI-DI
    00827002355514
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510(K) = K133114. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    INVESTIGATION ¿ EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, INSTRUCTIONS FOR USE, MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL OF THE DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD SHOWS 3 NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE; HOWEVER, ALL NONCONFORMING PRODUCT WAS SCRAPPED AND NOT REPLACED. IT SHOULD BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A VENOGRAM WITH A THROMBOLYSIS PROCEDURE THE WIRE PORTION OF THE MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET MET RESISTANCE AND BECAME KINKED UPON INSERTION. DURING WITHDRAWAL OF THE WIRE THROUGH THE SHEATH, THE DISTAL PORTION OF THE WIRE SHEARED OFF AND WAS RETAINED IN THE PATIENT¿S VEIN. ACCORDING TO INFORMATION RECEIVED, THE PATIENT HAD VERY COMPLICATED ANATOMY WHICH MAY HAVE CONTRIBUTED TO THIS EVENT. THE PATIENT WAS TAKEN TO THE OPERATING ROOM WHERE SUCCESSFUL REMOVAL OF THE SHEARED PORTION WAS PERFORMED.THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT FOR AN UNSPECIFIED LENGTH OF TIME AND WAS SUBSEQUENTLY DISCHARGED HOME. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADDITIONAL ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE INITIAL INFORMATION WAS RECEIVED VIA USER FACILITY REPORT NUMBER 1316394638-2018-2 THAT WAS EMAILED TO COOK INC. BY THE FACILITY. ADDITIONAL INFORMATION WAS OBTAINED LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263530 MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET DYB INTRODUCER, CATHETER DYB COOK INC 00827002355514

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention