BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM LIGHTNING 7

    MDR report key: 16268941 · Received January 30, 2023

    Report

    Report Number
    3005168196-2023-00051
    Event Type
    Malfunction
    Date Received
    January 30, 2023
    Date of Event
    December 30, 2022
    Report Date
    March 6, 2023
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEW
    UDI-DI
    00815948022584
    PMA / PMN Number
    K210083
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING SECTION IS BEING UPDATED BASED ON ADDITIONAL INFORMATION PROVIDED BY A PENUMBRA SALES REPRESENTATIVE ON 01/24/2023: SECTION B. BOX 5. DESCRIBE EVENT OR PROBLEM. EVALUATION OF THE RETURNED CAT7 CONFIRMED THAT THE CATHETER WAS FRACTURED. IF THE CAT7 IS MANIPULATED FORCEFULLY OR AT AN ANGLE DURING USE, DAMAGE SUCH AS A KINK AND SUBSEQUENT FRACTURE MAY OCCUR. BASED ON THE REPORTED EVENT, THE DEVICE WAS PINCHED TOO HARD BY THE PHYSICIAN DURING USE. FURTHER EVALUATION REVEALED BENDS THROUGHOUT THE LENGTH OF THE CATHETER SHAFT. THIS DAMAGE WAS INCIDENTAL TO THE REPORTED COMPLAINT AND LIKELY OCCURRED DURING PACKAGING FOR RETURN TO PENUMBRA. DUE TO THE RETURNED DAMAGE THE CAT7 WAS UNABLE TO BE FUNCTIONALLY TESTED. 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.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY USING A LIGHTNING ASPIRATION TUBING (LIGHTNING), INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7), INDIGO SYSTEM SEPARATOR 7 (SEP7), AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN MADE APPROXIMATELY TWO TO THREE PASSES USING THE CAT7 AND SEP7. SUBSEQUENTLY, THE PHYSICIAN USED THE DILATOR TO OPEN THE CAT7 BACK UP AND THEN ATTEMPTED TO LOAD THE SEP7 INTO THE CAT7; HOWEVER, THE PHYSICIAN PINCHED THE CAT7 TOO HARD AND BROKE IT AT THE HUB. THEREFORE, THE CAT7 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6) AND THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Description of Event or Problem · 0

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY USING A LIGHTNING ASPIRATION TUBING (LIGHTNING), INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7), INDIGO SYSTEM SEPARATOR 7 (SEP7), AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN MADE APPROXIMATELY TWO TO THREE PASSES USING THE CAT7 AND SEP7. SUBSEQUENTLY, THE PHYSICIAN USED THE DILATOR TO OPEN THE CAT7 BACK UP AND THEN ATTEMPTED TO LOAD THE SEP7 INTO THE CAT7; HOWEVER, THE CAT7 BROKE AT THE HUB. THEREFORE, THE CAT7 WAS REMOVED THE PROCEDURE WAS COMPLETED USING AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6) AND THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1033713 INDIGO SYSTEM LIGHTNING 7 QEW QEW PENUMBRA, INC. H00000605 00815948022584

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female