BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATK TURBOHAWK SMOOTH

    MDR report key: 22935948 · Received September 2, 2025

    Report

    Report Number
    9612164-2025-04314
    Event Type
    Malfunction
    Date Received
    September 2, 2025
    Date of Event
    August 1, 2025
    Report Date
    December 5, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MCW
    UDI-DI
    00763000918934
    PMA / PMN Number
    K170191
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    IMAGE ANALYSIS THE IMAGE SHOWS A TURBOHAWK DEVICE WITH THE DRIVESHAFT PROTRUDING OUT THROUGH A HOLE ON THE DISTAL END OF THE TORQUE SHAFT. THE PAPERWORK CONFIRMS THAT THE LOT # IS 0012571509. PRODUCT ANALYSIS A VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THAT THE CUTTER IS POSITIONED IN THE CUTTER WINDOW, (PHOTO 3) AND A HOLE ON THE DISTAL END OF THE TORQUE SHAFT, THE PUSHER/PISTON IS POSITIONED IN THE HOUSING, A CUTTERDRIVER FROM THE LAB WAS ATTACHED, THE THUMBSWITCH WAS ADVANCED AND THE DRIVESHAFT PROTRUDED OUT THROUGH THE HOLE IN THE TORQUE SHAFT, MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DIRECTED RESECTION PROCEDURE USING THE ATHERECTOMY TH-LX-M TURBOHAWK ATK, A PATIENT PRESENTED WITH A 70% STENOSIS LESION IN THE MID LEFT SUPERFICIAL FEMORAL ARTERY CHARACTERIZED AS CALCIFIED, FIBROUS, AND PLAQUE. MODERATE CALCIFICATION WAS NOTED, AND THE ARTERY DIAMETER WAS 6 MILLIMETERS. NO ISSUES DURING PREPARATION. A 5MM SPIDER FX EMBOLIC PROTECTION DEVICE WAS USED. THE VESSEL WAS PRE-DILATED AND POST-DILATED. DURING THE PROCEDURE, A DAMAGED CUTTER COMPONENT WAS DETECTED; HOWEVER, NO RESISTANCE WAS FELT DURING ADVANCEMENT, AND THE DAMAGED COMPONENT DID NOT REQUIRE RETRIEVAL FROM THE PATIENT. AFTER THE DEVICE WAS REMOVED FROM THE BODY, THE CUSTOMER REPEATEDLY INSPECTED THE DAMAGED DEVICE, AND THE PISTON INSIDE THE COLLECTION CHAMBER FELL OUTSIDE (ON THE GROUND). A REPLACEMENT TURBOHAWK LX-M WAS USED TO COMPLETE THE PROCEDURE, AND THE SURGERY PROCEEDED SMOOTHLY WITHOUT IMPACT TO THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2074503 ATK TURBOHAWK SMOOTH CATHETER, PERIPHERAL, ATHERECTOMY MCW MEDTRONIC IRELAND 0012571509 00763000918934

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male