BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDIGO SYSTEM LIGHTNING 7

    MDR report key: 12716249 · Received October 28, 2021

    Report

    Report Number
    3005168196-2021-02429
    Event Type
    Injury
    Date Received
    October 28, 2021
    Date of Event
    October 2, 2021
    Report Date
    January 14, 2022
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEW
    UDI-DI
    00815948022584
    PMA / PMN Number
    K210323
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THIS COMPLAINT WAS SUBMITTED TO THE FDA BY THE USER FACILITY WITH THE FOLLOWING REFERENCE NUMBER: MW5104544. THE FOLLOWING SECTIONS ARE BEING UPDATED BASED ON ADDITIONAL INFORMATION INCLUDED IN THE USER FACILITY REPORT SUBMITTED TO THE FDA: 1. SECTION E. BOX 4. INITIAL REPORTER ALSO SENT REPORT TO FDA. 2. SECTION G. BOX 3. REPORT SOURCE. EVALUATION OF THE RETURNED CAT7 CONFIRMED A FRACTURE ON THE DISTAL SHAFT. FURTHER EVALUATION REVEALED STRETCHING NEAR THE FRACTURE SITE, INDICATING THAT THE DEVICE WAS LIKELY RETRACTED AGAINST RESISTANCE. IT WAS REPORTED THAT A THROMBOSED STENT WAS BEING TREATED AND THE TARGET ANATOMY WAS TORTUOUS. INTERACTION WITH THE STENT MAY HAVE CONTRIBUTED TO RESISTANCE DURING MANIPULATION OF THE DEVICE DURING THE PROCEDURE. IF THE CAT7 IS FORCEFULLY RETRACTED AGAINST RESISTANCE, DAMAGE SUCH AS FRACTURES MAY OCCUR. FURTHER EVALUATION REVEALED AN ADDITIONAL FRACTURE, DISTAL KINKS, BENDS ALONG THE LENGTH OF THE CATHETER. THIS DAMAGE WAS LIKELY INCIDENTAL TO THE REPORTED COMPLAINT AND MAY HAVE OCCURRED DURING THE RETRIEVAL OF THE DISTAL FRACTURED SEGMENT. 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 SECTION WAS INCORRECTLY REPORTED ON THE INITIAL MFR REPORT AND IS BEING CORRECTED ON THIS FOLLOW-UP #02 MFR REPORT:3005168196-2021-024291.SECTION D. BOX 1. BRAND NAME. 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 IN THE SUPERFICIAL FEMORAL ARTERY (SFA) USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7), A NON-PENUMBRA GUIDE SHEATH AND A GUIDEWIRE. IT WAS NOTED THAT THE VESSEL WHICH WAS LINED WITH THE ALREADY IMPLANTED STENT WAS SLIGHTLY TORTUOUS AND THE STENT HAD THROMBOSED. DURING THE PROCEDURE, THE PHYSICIAN MADE THREE PASSES USING THE CAT7. WHILE RETRACTING THE CAT7 AFTER COMPLETION OF THE THIRD PASS IN ORDER TO FLUSH THE CAT7, THE DISTAL END OF THE CAT7 BROKE. THEREFORE, THE PHYSICIAN REMOVED THE BROKEN CAT7 FROM THE PATIENT VIA OPEN SURGERY. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1610236 INDIGO SYSTEM LIGHTNING 7 QEW QEW PENUMBRA, INC. LITNG7XTORQ130-A F104728 00815948022584

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention