BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM ASPIRATION CATHETER 7D

    MDR report key: 16103628 · Received January 5, 2023

    Report

    Report Number
    3005168196-2023-00006
    Event Type
    Malfunction
    Date Received
    January 5, 2023
    Date of Event
    December 12, 2022
    Report Date
    April 2, 2023
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEW
    UDI-DI
    00815948023987
    PMA / PMN Number
    K210083
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    ADDITIONAL 510(K)# THAT ALSO APPLY TO THIS COMPLAINT: K193595. EVALUATION OF THE RETURNED CAT7D CONFIRMED THAT THE CATHETER WAS FRACTURED NEAR THE HUB. IF THE CAT7D IS ADVANCED AGAINST RESISTANCE, DAMAGE SUCH AS A KINK AND SUBSEQUENT FRACTURE MAY OCCUR. THE KINK NEAR THE HUB IN THE NON-PENUMBRA SHEATH MAY HAVE CONTRIBUTED TO RESISTANCE IF THE KINK WAS PRESENT PRIOR TO THE CAT7D FRACTURING DURING THE PROCEDURE. THE NON-PENUMBRA SHEATH WAS KINKED NEAR THE HUB AND DAMAGED AT THE DISTAL TIP. BASED ON THE REPORTED COMPLAINT, THIS DAMAGE OCCURRED WHEN THE CAT7D FRACTURED. DUE TO THE DAMAGE ON THE NON-PENUMBRA SHEATH, A DEMONSTRATION CAT7D WAS NOT FUNCTIONALLY TESTED THROUGH THE NON-PENUMBRA SHEATH DURING EVALUATION. 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.

    Description of Event or Problem · 0

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT A THROMBOSED ARTERIOVENOUS (AV) FISTULA GRAFT IN THE BRACHIAL ARTERY AND CEPHALIC VEIN USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7), A NON-PENUMBRA SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED A PASS USING THE CAT7. WHILE ADVANCING THE CAT7 DURING THE SECOND PASS, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE CAT7 WOULD NOT ADVANCE WELL THROUGH THE GRAFT. SUBSEQUENTLY, THE PHYSICIAN KINKED THE PROXIMAL END OF THE CAT7. THEREFORE, THE CAT7 WAS REMOVED. THE PHYSICIAN THEN ADVANCED A NEW CAT7 OVER THE GUIDEWIRE AND THROUGH THE SHEATH INTO THE TARGET LOCATION AND COMPLETED TWO PASSES. THEN, WHILE ADVANCING THE CAT7 FOR THE THIRD PASS, THE PHYSICIAN BROKE THE PROXIMAL END OF THE CAT7 IN HALF. THEREFORE, THE PHYSICIAN REMOVED THE PROXIMAL BROKEN HALF OF THE CAT7 AND THEN REMOVED THE SHEATH CONTAINING THE DISTAL BROKEN HALF OF THE CAT7. IT WAS REPORTED THAT THE SHEATH BECAME DAMAGE WHEN THE CAT7 BROKE. THE PROCEDURE WAS COMPLETED BY ANGIOPLASTY USING A NEW NON-PENUMBRA SHEATH AND TRAWLING BALLOONS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Description of Event or Problem · 0

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT A THROMBOSED ARTERIOVENOUS (AV) FISTULA GRAFT IN THE BRACHIAL ARTERY AND CEPHALIC VEIN USING AN INDIGO SYSTEM ASPIRATION CATHETER 7D (CAT7D), A NON-PENUMBRA SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED A PASS USING THE CAT7D. WHILE ADVANCING THE CAT7D DURING THE SECOND PASS, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE CAT7D WOULD NOT ADVANCE WELL THROUGH THE GRAFT. SUBSEQUENTLY, THE PHYSICIAN KINKED THE PROXIMAL END OF THE CAT7D. THEREFORE, THE CAT7D WAS REMOVED. THE PHYSICIAN THEN ADVANCED A NEW CAT7D OVER THE GUIDEWIRE AND THROUGH THE SHEATH INTO THE TARGET LOCATION AND COMPLETED TWO PASSES. THEN, WHILE ADVANCING THE CAT7D FOR THE THIRD PASS, THE PHYSICIAN FRACTURED THE PROXIMAL END OF THE CAT7D IN HALF. THEREFORE, THE PHYSICIAN REMOVED THE PROXIMAL FRACTURED HALF OF THE CAT7D AND THEN REMOVED THE SHEATH CONTAINING THE DISTAL FRACTURED HALF OF THE CAT7D. IT WAS REPORTED THAT THE SHEATH BECAME DAMAGE WHEN THE CAT7D FRACTURED. THE PROCEDURE WAS COMPLETED BY ANGIOPLASTY USING A NEW NON-PENUMBRA SHEATH AND TRAWLING BALLOONS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1645529 INDIGO SYSTEM ASPIRATION CATHETER 7D QEW QEW PENUMBRA, INC. H12753 00815948023987

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female