BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAWKONE

    MDR report key: 4905447 · Received July 10, 2015

    Report

    Report Number
    2183870-2015-00236
    Event Type
    Malfunction
    Date Received
    July 10, 2015
    Date of Event
    June 4, 2015
    Report Date
    July 2, 2015
    Manufacturer
    COVIDIEN
    Product Code
    MCW
    PMA / PMN Number
    K141801
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING SUBMITTED AS A PART OF A RETROSPECTIVE REVIEW / REMEDIATION EFFORT PERFORMED AT THE COVIDIEN (B)(4) LOCATION, FOLLOWING MEDTRONIC¿S ACQUISITION OF COVIDIEN. A CAPA HAS BEEN OPENED TO MANAGE THE ACTIONS RELATED TO REMEDIATION OF COMPLAINT FILES AND ANY REQUIRED MDR REPORTING.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURE RECORDS FOR THIS DEVICE DID NOT REVEAL ANY DISCREPANCIES RELEVANT TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    THIS PROCEDURE WAS PERFORMED ON THE LEFT PROXIMAL SFA BY CONTRALATERAL APPROACH. THE LESION WAS SOFT BLACK WITH NO CALCIUM NOTED. DURING THE FIRST INSERTION (WITH THE DEVICE WITH THE LOT NUMBER OF A045627) SEVERAL CUTS WERE MADE IN THE DEVICE WAS REMOVED TO BE CLEANED. THE DEVICE WAS DIFFICULT TO REMOVE THROUGH THE SHEATH AND A BULGING AREA IN THE MIDDLE OF THE NOSECONE WAS NOTED. A NEW DEVICE (WITH THE LOT NUMBER A073025) WAS OPEN TO PERFORM THE REMAINDER OF THE CASE BUT A SIMILAR OCCURRENCE HAPPENED AND THE DEVICE CANNOT BE REMOVED THROUGH THE SHEATH WITHOUT REMOVING THE SHEATH AND HAWKONE DEVICE, THEN REINSERTING THE SHEATH. THERE WAS A RADIOGRAPHIC DEFORMITY VISIBLE ON THE IMAGE ACCORDING TO THE PHYSICIAN. UPON INSPECTION, THERE SEEM TO BE A PERFORATION AT THE DISTAL PORTION OF THE TIP ABOVE THE NOSECONE AREA. IT WAS DECIDED AT THIS POINT TO PLACE A STENT ACROSS THE DISEASED AREA AND THE CASE WAS FINISHED WITHOUT FURTHER INCIDENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PROCEDURE NOTES, STATING, "A 6MM SPIDER WIRE WAS DEPLOYED INTO THE MOST DISTAL POPLITEAL ARTERY AND THE FIRST OF TWO HAWKONE DEVICES WAS APPLIED ACROSS THE TCO FOR A TOTAL OF FOUR CUTS, EACH AT ABOUT 90 DEGREES FROM EACH OTHER. THERE WAS MILD DIFFICULTY AND WITHDRAWING THIS DEVICE THROUGH THE SHEATH BUT A CONSIDERABLE AMOUNT OF WHITE ATHEROMA WAS REMOVED FROM THE NOSECONE. FOLLOWING THIS HOWEVER THE DEVICE WOULD NOT SUCCESSFULLY DEPLOY OUT OF THE BODY AND IT WAS EXCHANGED FOR A SECOND HAWKONE DEVICE. THIS DEVICE WAS APPLIED DIRECTIONALLY AGAINST RESIDUAL OCCLUSIVE DISEASE IN THE TCO AS WELL AS SOME SEGMENTS OF THE MORE PROXIMAL PARTIALLY OCCLUSIVE DISEASE. PRIOR TO EVEN FILLING OF THE NOSECONE HOWEVER THIS DEVICE WAS WITHDRAWN BUT IT WOULD NOT WITHDRAW THROUGH THE SHEATH. ANGIOGRAMS DEMONSTRATED A ROUND FILLING DEFECT DENSELY ADHERENT TO THE DISTAL PORTION OF TH NOSECONE AND IT WAS POSTULATED THAT THIS WAS ATHEROMA WHICH HAD BALLOONED OUT INTO THE CASING OF THE NOSECONE PRECLUDING SAFE WITHDRAWAL OF THE NOSECONE THROUGH THE ARTERY. A 5X20 MM BALLOON WAS ADVANCED ALONGSIDE THIS BOLUS OF DEBRIS AND IT WAS ANGIOPLASTY FROM SEVERAL DIFFERENT DIRECTIONS HOPING TO INCREASE THE MALLEABILITY OF THIS BOLUS OF DEBRIS AND IT WAS ANGIOPLASTY FROM SEVERAL DIFFERENT DIRECTIONS HOPING TO INCREASE THE MALLEABILITY OF THIS BOLUS OF ATHEROMA. THIS DID ALLOW FOR REMOVAL WITH SOME FORCE OF THE NOSECONE THROUGH THE SHEATH BUT UPON EXAMINATION...THERE WAS A RUPTURED BLOWN-OUT AREA IN THE DISTAL NOSECONE CONSISTENT WITH THE LESION...AND IT WAS ERUPTING ATHEROMA THROUGH THE RUPTURED NOSECONE PLASTIC. ASPIRATING THROUGH THE SHEATH REMOVED ADDITIONAL ATHEROMA." REFERENCE MDR 2183870-2015-00237 FOR THE OTHER HAWKONE USED IN THIS PROCEDURE.

    Description of Event or Problem · 1

    EVALUATION SUMMARY: THE HAWKONE DEVICE WAS RECEIVED IN TWO BIO-HAZARDOUS POUCHES WITH THE LOT STICKER APPLIED. THE LOT NUMBER INDICATED ON THE STICKER WAS (B)(4). THE DISTAL ASSEMBLY SHOWED A BURST OR SLICE APPROXIMATELY 1CM FROM THE CUTTER WINDOW. THE DAMAGED PORTION OF THE DISTAL ASSEMBLY WAS INSPECTED UNDER MICROSCOPE. THE TECOTHANE APPEARS TO HAVE BURST OR SLICED OPEN. WITHIN THE SLICE AND CLOSE PROXIMITY THE STAINLESS STEEL COILS ARE BENT INWARD AND SHOW SIGNS OF FRACTURING. NO OTHER DAMAGE TO THE DISTAL ASSEMBLY OR OTHER COMPONENTS OF THE HAWKONE WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449633 HAWKONE ATHERECTOMY PERIPHERAL CATHETER MCW COVIDIEN H1-LS A045627

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other