BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROPUNCTURE TRANSITIONLESS ACCESS SET

    MDR report key: 9125091 · Received September 26, 2019

    Report

    Report Number
    1820334-2019-02432
    Event Type
    Injury
    Date Received
    September 26, 2019
    Date of Event
    September 19, 2019
    Report Date
    February 21, 2020
    Manufacturer
    COOK INC
    Product Code
    DYB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION - EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURER¿S INSTRUCTIONS, AND THE QUALITY CONTROL PROCEDURES OF THE DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THIS DEVICE IS PROVIDED TO US BY A SUPPLIER, AS SUCH A SUPPLIER INVESTIGATION WAS PERFORMED. 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 SPECIFICATIONS CONFIRMED THAT THE PRODUCT WAS MANUFACTURED TO SPECIFICATION. THE SUPPLIER REVIEWED THE DEVICE HISTORY RECORD AND NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE WERE NOTED. ADDITIONALLY, COOK PERFORMED A REVIEW OF THE QUALITY CONTROL PROCEDURES AS WELL AS THE MANUFACTURING INSTRUCTIONS, AND NO GAPS WERE DISCOVERED. WHILE THE EXACT REASON FOR THE FAILURE COULD NOT BE DETERMINED BASED ON THE INFORMATION PROVIDED, A LIKELY REASON FOR THE FAILURE MAY INCLUDE DIFFICULTY ENCOUNTERED DUE TO PATIENT ANATOMY. 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 = UNKNOWN. PMA/510(K) NUMBER = K171275. (B)(4). 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 FISTULOPLASTY OF AN ARTERIOVENOUS FISTULA INVOLVING A PATIENT WITH A HISTORY OF HEMODIALYSIS, THE MICROPUNCTURE TRANSITIONLESS ACCESS SET DILATOR SEPARATED INSIDE THE PATIENT. ACCESS WAS OBTAINED "DOWN STREAM", DISTAL TO THE PERIANASTOMOTIC REGION. A VENOGRAM DEMONSTRATED STENOSIS, AND THE DILATOR SEPARATED UPON REMOVAL OF THE DEVICE. THE USER ATTEMPTED TO REMOVE THE SEPARATED PORTION OVER AN UNKNOWN 7 FRENCH SHEATH, WHICH WAS NOT SUCCESSFUL, AND THE DILATOR MIGRATED TO THE DISTAL CEPHALIC VEIN. AN "UPSTREAM" PROCEDURE WAS PERFORMED USING A 10 FRENCH SHEATH. AN UNKNOWN 4 MILLIMETER MICROSNARE WAS USED TO RETRIEVE THE SEPARATED PORTION OF THE DEVICE. REPORTEDLY, STENOSIS OF THE SUBCLAVIAN FACILITATED RETRIEVAL. MANUAL COMPRESSION WAS APPLIED TO THE "UPSTREAM" PUNCTURE SITE. ACCORDING TO THE REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    919693 MICROPUNCTURE TRANSITIONLESS ACCESS SET DYB INTRODUCER, CATHETER DYB COOK INC 9864640

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR UNKNOWN J WIRE