BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM SEPARATOR D

    MDR report key: 11822627 · Received May 13, 2021

    Report

    Report Number
    3005168196-2021-01034
    Event Type
    Malfunction
    Date Received
    May 13, 2021
    Date of Event
    April 15, 2021
    Report Date
    July 28, 2021
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEW
    PMA / PMN Number
    K161523
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THE DEVICE ASSOCIATED WITH THIS COMPLAINT WAS EXPECTED TO BE RETURNED; HOWEVER, ADDITIONAL INFORMATION RECEIVED FROM THE PENUMBRA SALES REPRESENTATIVE INDICATED THAT THE DEVICE WAS LOST IN TRANSIT AND IS NO LONGER AVAILABLE FOR RETURN. THEREFORE, WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED. BASED ON THIS INFORMATION, CORRECTIONS WERE MADE TO: 1. SECTION D. BOX 10. DEVICE AVAILABLE FOR EVALUATION? (DO NOT SEND TO FDA). 2. SECTION H. BOX 3. REASON FOR NON-EVALUATION. 3. SECTION H. BOX 3. ''OTHER'' REASON FOR NON-EVALUATION. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS. H3 OTHER TEXT : PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS AVAILABLE FOR RETURN. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT A DIALYSIS ARTERIOVENOUS FISTULA (AVF) USING AN INDIGO SYSTEM SEPARATOR D (SEPD) AND AN INDIGO SYSTEM CATD ASPIRATION CATHETER (CATD). IT WAS NOTED THAT THERE WAS SOME STENOSIS IN THE FISTULA. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED TWO PASSES USING THE SEPD AND CATD. WHILE ADVANCING THE SEPD INTO THE CATD FOR EITHER THE THIRD OR FOURTH PASS, IT WAS NOTICED UNDER X-RAY THAT THE ATRAUMATIC TIP OF THE SEPD BROKE OFF. THEREFORE, THE BROKEN ATRAUMATIC TIP OF THE SEPD WAS ASPIRATED OUT USING THE CATD. THE PROCEDURE WAS COMPLETED BY ONE ADDITIONAL PASS USING THE SAME CATD. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717104 INDIGO SYSTEM SEPARATOR D QEW QEW PENUMBRA, INC. F91232

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR