BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAWKONE

    MDR report key: 4905448 · Received July 10, 2015

    Report

    Report Number
    2183870-2015-00237
    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. (B)(4).

    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 A073025. THE DEVICE WAS REMOVED FROM THE BAG AND VISUALLY INSPECTED. THE DISTAL ASSEMBLY SHOWED THE STAINLESS STEEL COIL DEFORMED/ELONGATED AT VARIOUS SEGMENTS OF THE ASSEMBLY. THE DISTAL ASSEMBLY SHOWED DAMAGE TO THE TECOTHANE COATING APPROXIMATELY 5CM FROM THE CUTTER WINDOW, WHICH SHOWS AN ENLARGED DIAMETER. AT THE APEX OF THE DAMAGED TECOTHANE IT APPEARS TO HAVE BEEN RIPPED AND THE COIL BENEATH THE DAMAGED TECOTHANE APPEARS BENT. IMMEDIATELY PROXIMAL TO THE EXPANDED DIAMETER AT THE DISTAL END ANOTHER LOCATION ON THE DISTAL ASSEMBLY APPEARS TO HAS BEEN SLICED, THE COIL BENEATH IS ALSO BENT. IT SHOULD BE NOTED THE OVERALL STRUCTURAL INTEGRITY SEEMED TO BE COMPROMISED; THE DISTAL ASSEMBLY WAS ABLE TO BEND WITH LITTLE TO NO RESISTANCE. THE GUIDEWIRE TUBING JUST BELOW THE DAMAGED TECOTHANE HAD A SMALL TEAR. THE TEAR WAS BIG ENOUGH TO HAVE A 0.014" GUIDE WIRE PROTRUDE. IT SHOULD BE NOTED THE TEAR DOES NOT CONTINUE THROUGHOUT THE GUIDEWIRE TUBING. IT WAS ALSO OBSERVED THE TECOTHANE COATING APPEARS TO HAVE RETRACTED APPRO XIMATELY 1MM.

    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. THE 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 THE 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 2183870-2015-00236 FOR THE OTHER HAWKONE USED IN THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450363 HAWKONE ATHERECTOMY PERIPHERAL CATHETER MCW COVIDIEN H1-LS A073025

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other