BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDIGO SYSTEM SEPARATOR 8

    MDR report key: 8745326 · Received June 28, 2019

    Report

    Report Number
    3005168196-2019-01281
    Event Type
    Injury
    Date Received
    June 28, 2019
    Date of Event
    May 31, 2019
    Report Date
    May 31, 2019
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DXE
    UDI-DI
    00814548017440
    PMA / PMN Number
    K161523
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    RESULTS: THE INDIGO SYSTEM SEPARATOR 8 (B)(6) CORE WIRE AND WRAPPING WIRE WERE FRACTURED DISTAL TO THE BULB. CONCLUSIONS: EVALUATION OF THE RETURNED (B)(6) CONFIRMED THE ATRAUMATIC TIP DISTAL TO THE BULB WAS FRACTURED. IF THE DEVICE IS FORCEFULLY MANIPULATED REPEATEDLY THROUGH TOUGH CLOT BURDEN, DAMAGE SUCH AS THIS MAY OCCUR. IF THE CORE WIRE FRACTURES, THE WRAPPING WIRE MAY FATIGUE AND FRACTURE IF THE DEVICE CONTINUES TO BE USED. PENUMBRA CATHETERS ARE INSPECTED DURING IN-PROCESS INSPECTION AND DURING QUALITY INSPECTION AFTER MANUFACTURING. 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 · 0

    PLEASE NOTE THAT THE FOLLOWING SECTIONS WERE INCORRECTLY REPORTED ON THE INITIAL MFR REPORT AND ARE BEING CORRECTED ON THIS FOLLOW-UP #02 MFR REPORT:3005168196-2019-01281. 1. SECTION B. BOX 1. ADVERSE EVENT AND/OR PRODUCT PROBLEM. 2. SECTION G. BOX 5. 510(K). 3. SECTION H. BOX 1. TYPE OF REPORTABLE EVENT H3 OTHER TEXT : PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION RESULTS ARE PENDING. 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 IN THE PULMONARY ARTERY USING AN INDIGO SYSTEM SEPARATOR 8 (SEP8). DURING THE PROCEDURE, THE PHYSICIAN MADE A SUCCESSFUL PASS USING THE SEP8 WITH AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) AND A NON-PENUMBRA SHEATH. THE PHYSICIAN THEN PLACED THE CAT8 OUT IN THE DISTAL OF THE RIGHT PULMONARY ARTERY AND ATTEMPTED TO MAKE ANOTHER PASS WITH THE SEP8; HOWEVER, THE PHYSICIAN NOTICED THAT THE WIRE DISTAL TO BULB ON THE SEP8 HAD COME OFF IN THE DISTAL BRANCH OF THE PULMONARY ARTERY. THE PHYSICIAN ATTEMPTED TO ASPIRATE THE BROKEN TIP WITH THE CAT8; HOWEVER, WAS UNSUCCESSFUL. THE PROCEDURE WAS THEN COMPLETED USING THE SAME CAT8 TO MAKE A FINAL PASS. IT WAS NOTED THAT TISSUE PLASMINOGEN ACTIVATOR (TPA) DRIP WAS ADMINISTERED OVERNIGHT TO REMOVE THE REST OF THE CLOT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540207 INDIGO SYSTEM SEPARATOR 8 DXE DXE PENUMBRA, INC. SEP8-A F87934 00814548017440

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR