BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WOLF THROMBECTOMY SYSTEM

    MDR report key: 17646310 · Received August 29, 2023

    Report

    Report Number
    2124215-2023-45246
    Event Type
    Malfunction
    Date Received
    August 29, 2023
    Date of Event
    August 4, 2023
    Report Date
    November 27, 2023
    Manufacturer
    DEVORO MEDICAL, INC
    Product Code
    QEW
    UDI-DI
    00850029546054
    PMA / PMN Number
    K210911
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVAL BY MFR: THE CATHETER WAS RETURNED WITHIN THE SHEATH, AND THE FUNNEL WAS DEPLOYED WITHIN THE SLEEVE. THE SLEEVE WAS ABLE TO BE REMOVED FROM THE CATHETER, AND THE CATHETER WAS REMOVED FROM THE SHEATH FOR DECONTAMINATION. THE WOLF CATHETER WAS EXAMINED FOR VISUAL ABNORMALITIES. IT WAS FOUND THAT THE SLEEVE WAS DAMAGED AND DETACHED APPROXIMATELY 33CM BETWEEN THE DISTAL END OF THE DEVORTEX SHAFT AND THE PROXIMAL END OF THE SLEEVE. IT WAS ALSO FOUND THAT THE MARKER BAND COATING APPROXIMATELY 68CM FROM THE STRAIN RELIEF WAS FLAKING OFF OF THE CATHETER. THERE WERE NO VISUAL ABNORMALITIES NOTED TO THE SHEATH. THE WOLF CATHETER WAS RELOADED WITH A NEW SLEEVE AND INSERTED INTO THE RETURNED SHEATH. THE CATHETER FUNNEL WAS ABLE TO BE DEPLOYED OUT OF THE END OF THE SHEATH AND A SUCCESSFUL SLEEVE PULL WAS PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SLEEVE DETACHED. A 12MM WOLF VENOUS THROMBECTOMY CATHETER WAS SELECTED FOR USE IS THE DISTAL FEMORAL VEIN. THE 12MM WOLF VENOUS CATHETER WAS SUCCESSFULLY ADVANCED THROUGH THE WOLF SHEATH. HOWEVER, THE FUNNEL ON THE WOLF VENOUS CATHETER COULD NOT DEPLOY AS IT WAS TOO LARGE. THE WOLF VENOUS CATHETER AND SHEATH WERE SUCCESSFULLY REMOVED AND EXCHANGED FOR NEW DEVICES. AN 8MM WOLF VENOUS THROMBECTOMY CATHETER WAS ADVANCED TO THE TARGET LESION AND SUCCESSFULLY USED. AS THE THROMBECTOMY PROCEDURE PROGRESSED INTO LARGER VENOUS ANATOMY (PROXIMAL FEMORAL ARTERY), IT WAS DETERMINED A LARGER WOLF VENOUS CATHETER WAS REQUIRED. A 12MM WOLF VENOUS CATHETER WAS THEN ADVANCED TO THE PROXIMAL FEMORAL VEIN, HOWEVER, IT WAS OBSERVED THAT THE CATHETER WAS TOO LARGE AS WELL. DURING REMOVAL OF THE WOLF VENOUS CATHETER INTO THE WOLF SHEATH, THE 12MM FUNNEL SLEEVE DETACHED. THE 12MM FUNNEL WOLF CATHETER, SLEEVE AND WOLF SHEATH WERE ALL ABLE TO BE REMOVED FROM THE PATIENT EASILY WITH NO HARM TO THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SLEEVE DETACHED. A 12MM WOLF VENOUS THROMBECTOMY CATHETER WAS SELECTED FOR USE IS THE DISTAL FEMORAL VEIN. THE 12MM WOLF VENOUS CATHETER WAS SUCCESSFULLY ADVANCED THROUGH THE WOLF SHEATH. HOWEVER, THE FUNNEL ON THE WOLF VENOUS CATHETER COULD NOT DEPLOY AS IT WAS TOO LARGE. THE WOLF VENOUS CATHETER AND SHEATH WERE SUCCESSFULLY REMOVED AND EXCHANGED FOR NEW DEVICES. AN 8MM WOLF VENOUS THROMBECTOMY CATHETER WAS ADVANCED TO THE TARGET LESION AND SUCCESSFULLY USED. AS THE THROMBECTOMY PROCEDURE PROGRESSED INTO LARGER VENOUS ANATOMY (PROXIMAL FEMORAL ARTERY), IT WAS DETERMINED A LARGER WOLF VENOUS CATHETER WAS REQUIRED. A 12MM WOLF VENOUS CATHETER WAS THEN ADVANCED TO THE PROXIMAL FEMORAL VEIN, HOWEVER, IT WAS OBSERVED THAT THE CATHETER WAS TOO LARGE AS WELL. DURING REMOVAL OF THE WOLF VENOUS CATHETER INTO THE WOLF SHEATH, THE 12MM FUNNEL SLEEVE DETACHED. THE 12MM FUNNEL WOLF CATHETER, SLEEVE AND WOLF SHEATH WERE ALL ABLE TO BE REMOVED FROM THE PATIENT EASILY WITH NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2082707 WOLF THROMBECTOMY SYSTEM PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION QEW DEVORO MEDICAL, INC 0000200071 00850029546054

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown