BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM ASPIRATION CATHETER 6

    MDR report key: 8786928 · Received July 12, 2019

    Report

    Report Number
    3005168196-2019-01353
    Event Type
    Malfunction
    Date Received
    July 12, 2019
    Date of Event
    June 12, 2019
    Report Date
    June 12, 2019
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DXE
    UDI-DI
    00814548016245
    PMA / PMN Number
    K160533
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THE FOLLOWING SECTIONS WERE INCORRECTLY REPORTED ON THE INITIAL MFR REPORT AND IS BEING INCLUDED ON THIS FOLLOW-UP #01 MFR REPORT:3005168196-2019-01353. 1. SECTION B. BOX 1. ADVERSE EVENT AND/OR PRODUCT PROBLEM. 2. SECTION B. BOX 2. OUTCOMES ATTRIBUTED TO ADVERSE EVENT (SELECT ALL THAT APPLY). 3. SECTION B. BOX 5. DESCRIBE EVENT OR PROBLEM. 4. SECTION H. BOX 1. TYPE OF REPORTABLE EVENT. 5. SECTION H. BOX 6. EVALUATION CODES PATIENT CODE 1. RESULTS: THE RETURNED CAT6 WAS OVALIZED AT APPROXIMATELY 99.0 CM, 132.0 CM AND 135.0 CM FROM THE HUB. THE DEVICE WAS KINKED AT APPROXIMATELY 119.0 CM AND 128.0 CM FROM THE HUB. DURING FUNCTIONAL TESTING, AN 0.070¿ TEST MANDREL WAS ATTEMPTED TO ADVANCE THROUGH THE CAT6, AND RESISTANCE WAS ENCOUNTERED AT OVALIZED LOCATION. THE CAT6 WAS CONNECTED TO A DEMONSTRATION PUMP IN ATTEMPT TO ASPIRATE WATER. HOWEVER, THE CATHETER WAS UNABLE TO ASPIRATE WATER AS INTENDED DUE TO THE OVALIZATION ON THE CATHETER. CONCLUSIONS: EVALUATION OF THE RETURNED CAT6 CONFIRMED THE DISTAL TIP DAMAGE AND INABILITY TO ASPIRATE. THE OBSERVED DISSECTION WAS REPORTED TO HAVE POSSIBLY CONTRIBUTED TO THE DISTAL CAT6 DAMAGE. IF THE CAT6 IS REPEATEDLY MANIPULATED WITHIN DIFFICULTY PATIENT ANATOMY, THE CATHETER MAY BECOME DAMAGED. THE INABILITY TO ASPIRATE EXPERIENCED DURING THE PROCEDURE AND FUNCTIONAL TESTING WAS LIKELY A RESULT OF THE DISTAL OVALIZATIONS ON THE CAT6. FURTHER EVALUATION REVEALED KINKS ON THE CAT6 THAT WERE LIKELY INCIDENTAL TO THE REPORTED COMPLAINT. 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.

    Description of Event or Problem · 0

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE COMMON ILIAC ARTERY (CIA) USING AN INDIGO SYSTEM CAT 6 ASPIRATION CATHETER (CAT6). IT WAS REPORTED THAT THE PATIENT HAD A NON-PENUMBRA VENTRICULAR ASSIST DEVICE (VAD) REMOVED 48 HOURS PRIOR TO THE PROCEDURE. THE PHYSICIAN BELIEVED THE DEVICE MAY HAVE DAMAGED THE ILIAC ARTERY CAUSING THE OCCLUSION. DURING THE PROCEDURE, THE PHYSICIAN WAS ABLE TO GET A GUIDEWIRE THROUGH THE OCCLUSION AND INPUT A DISTAL PROTECTION DEVICE IN THE PROXIMAL PORTION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) TO PROTECT FROM DISTAL EMBOLI. THE PHYSICIAN PROCEEDED WITH A CAT6 TO ASPIRATE THE CLOT AND AFTER TWO PASSES, THE CAT6 WAS REMOVED DUE TO NO FLOW IN THE CANISTER. UPON REMOVAL, IT WAS FOUND THAT THE TIP OF THE CAT6 WAS FLAT AND LOOKED TWISTED. A SECOND CAT6 WAS USED TO OPEN THE TARGET VESSEL AND A DISSECTION WAS NOTICED DURING AN ANGIOGRAM. IT WAS REPORTED THAT THE DISSECTION WAS TREATED USING BALLOON ANGIOPLASTY AND A COVERED STENT AND WAS LIKELY THE DAMAGED CAUSED BY THE VAD. THE PHYSICIAN BELIEVES THIS MAY HAVE CONTRIBUTED TO THE FIRST CAT6 TO BECOMING DAMAGED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THE SECOND CAT6 AND THE VESSEL WAS COVERED USING A STENT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    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 COMMON ILIAC ARTERY (CIA) USING AN INDIGO SYSTEM CAT 6 ASPIRATION CATHETER (CAT6). THE PATIENT HAD A NON-PENUMBRA DEVICE REMOVED 48 HOURS PRIOR TO THE PROCEDURE. THE PHYSICIAN BELIEVED THE DEVICE MAY HAVE DAMAGED THE ILIAC ARTERY CAUSING THE OCCLUSION. THE PHYSICIAN WAS ABLE TO GET A GUIDEWIRE THROUGH THE OCCLUSION AND INPUT A DISTAL PROTECTION DEVICE IN THE PROXIMAL PORTION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) TO PROTECT FROM DISTAL EMBOLI. THE PHYSICIAN PROCEEDED WITH A CAT6 TO ASPIRATE THE CLOT AND AFTER TWO PASSES, THE CAT6 WAS REMOVED DUE TO NO FLOW IN THE CANISTER. THEREFORE, THE CAT6 WAS REMOVED AND IT WAS FOUND THAT THE TIP WAS FLAT AND LOOKED TWISTED. A SECOND CAT6 WAS USED TO OPEN THE TARGET VESSEL AND A DISSECTION WAS NOTICED DURING AN ANGIOGRAM. IT WAS REPORTED THAT THE DISSECTION WAS REPAIRED USING BALLOON ANGIOPLASTY AND A COVERED STENT. THE PHYSICIAN BELIEVES THIS MAY HAVE CAUSED THE FIRST CAT6 TO BE FLATTENED AND TWISTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING THE SECOND CAT6 AND THE VESSEL WAS COVERED USING A STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578865 INDIGO SYSTEM ASPIRATION CATHETER 6 DXE DXE PENUMBRA, INC. F78588 00814548016245

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other