BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROPUNCTURE TRANSITIONLESS ACCESS SET

    MDR report key: 8713539 · Received June 19, 2019

    Report

    Report Number
    1820334-2019-01482
    Event Type
    Injury
    Date Received
    June 19, 2019
    Date of Event
    May 23, 2019
    Report Date
    August 30, 2019
    Manufacturer
    COOK INC
    Product Code
    DYB
    UDI-DI
    00827002438699
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. INVESTIGATION - EVALUATION. REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, MANUFACTURER¿S INSTRUCTIONS, AND QUALITY CONTROL PROCEDURES OF THE DEVICE WERE 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. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD SHOWS 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 MANUFACTURER¿S INSTRUCTIONS, QUALITY CONTROL PROCEDURES, AND THE OVERALL DEVICE HISTORY FILE WERE CONDUCTED, AND NO GAPS WERE DISCOVERED. BASED ON THE INFORMATION PROVIDED AND NO PRODUCT RETURNED, INVESTIGATION HAS CONCLUDED THAT A ROOT CAUSE FOR THIS EVENT COULD NOT BE ESTABLISHED. 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 = CPHRM. 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 ATHERECTOMY PROCEDURE INVOLVING A PATIENT OF UNKNOWN AGE AND GENDER, A MICROPUNCTURE TRANSITIONLESS ACCESS SET WIRE UNRAVELED AND SEPARATED. THIS REPORTEDLY OCCURRED WHILE BEING PASSED THROUGH THE NEEDLE UPON INITIAL PLACEMENT OF THE DEVICE INTO THE FEMORAL ARTERY; ALTHOUGH, THE PHYSICIAN WAS PULLING BACK ON THE WIRE WHEN THE SMALL PORTION DETACHED. THE DEVICE WAS USED TO FACILITATE PLACEMENT OF A LARGER DIAMETER WIRE. THE ACCESS SITE WAS DESCRIBED AS NORMAL AND IT IS UNKNOWN IF RESISTANCE WAS ENCOUNTERED. THE DETACHED PORTION, LOCATED JUST UNDER THE SKIN, WAS NOT RETRIEVED AND NO INTERVENTION IS CURRENTLY PLANNED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER DEVICE OF THE SAME TYPE. 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
    505451 MICROPUNCTURE TRANSITIONLESS ACCESS SET DYB INTRODUCER, CATHETER DYB COOK INC G43869 9622051 00827002438699

    Patients

    Seq Age Sex Outcome Treatment
    1 Other