BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAWKONE 6FR

    MDR report key: 10777677 · Received November 3, 2020

    Report

    Report Number
    9612164-2020-04213
    Event Type
    Malfunction
    Date Received
    November 3, 2020
    Date of Event
    October 23, 2020
    Report Date
    December 23, 2020
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MCW
    UDI-DI
    00643169968332
    PMA / PMN Number
    K161361
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT ANALYSIS: THE HAWKONE CONNECTED TO A CUTTER DRIVER WAS RETURNED INSIDE A PREVIOUSLY OPENED HAWKONE BOX AND POUCH WHICH BOTH INDICATED LOT 0010 252169. A 0.014" GW WAS LOADED THE DISTAL ASSEMBLY. NO ANCILLARY DEVICES WERE INCLUDED. A VISUAL INSPECTION OF THE RETURNED HAWKONE SHOWED THE TORQUE SHAFT WAS BENT AT AN APPROXIMATE 90 DEGREE ANGLE BENEATH THE STRAIN RELIEF. IT IS LIKELY THIS DAMAGE WAS NOT AFFILIATED WITH THE AS REPORTED EVENT AND OCCURRED DURING HANDLING POST-PROCEDURE. THE 0.014" GW WAS LOADED THROUGH THE GW LUMEN OF THE ROTATING TIP AND THE COILED HOUSING ASSEMBLY. THE PROXIMAL END OF THE GW TUBING SHOWED THE ONSET OF ZIPPER TEARING. BUCKLING OF TUBING WAS NOTED AND A TEAR WAS OBSERVED AT THE APPROXIMATE AREA OF THE ANCHOR POCKETS OF THE HOUSING. THE GUIDEWIRE EXPOSED OUTSIDE THE PROXIMAL END OF THE GW TUBING OF THE HAWKONE WAS BEND AT AN APPROXIMATE 100-DEGREE ANGLE AT APPROXIMATELY 1 CM PROXIMAL TO THE GW TUBING. NO OTHER DAMAGES TO THE DEVICE WERE OBSERVED. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PHYSICIAN WAS ATTEMPTING TO USE A HAWKONE DIRECTIONAL ATHERECTOMY WITH A 6FR NON-MEDTRONIC SHEATH AND A NON-MEDTRONIC GUIDEWIRE DURING A PROCEDURE TO TREAT A LESION IN THE POPLITEAL ARTERY. IFU WAS FOLLOWED. GUIDEWIRE ADVANCEMENT/ LOCK-UP/ PROLAPSE/ LUMEN TORN/RIPPED OCCURRED. THE GUIDEWIRE WAS HYDRATED AT PREPARATION. THE GUIDEWIRE LUMEN WAS TORN FROM THE DISTAL TIP. RESISTANCE WAS FELT DURING ADVANCEMENT OF THE HAWK OVER THE GUIDEWIRE AT THE END. THE HAWK WOULD NOT TRACK THE NOSECONE. THE WIRE FRACTURED AND GOT STUCK IN THE DEVICE. THE WIRE WAS REMOVED IN TANDEM AND VESSEL ACCESS WAS LOST. THE ISSUE OCCURRED AFTER MULTIPLE PASSES WITH HAWK IN FIRST INSERTION. A PTA BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1244126 HAWKONE 6FR CATHETER, PERIPHERAL, ATHERECTOMY MCW MEDTRONIC IRELAND H1-M 0010252169 00643169968332

    Patients

    Seq Age Sex Outcome Treatment
    1