BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WOLF THROMBECTOMY SYSTEM

    MDR report key: 17603461 · Received August 23, 2023

    Report

    Report Number
    2124215-2023-44830
    Event Type
    Injury
    Date Received
    August 23, 2023
    Date of Event
    July 26, 2023
    Report Date
    September 15, 2023
    Manufacturer
    DEVORO MEDICAL, INC
    Product Code
    QEW
    UDI-DI
    00850029546030
    PMA / PMN Number
    K210911
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE ANALYSIS BY MFR: THE DEVICE WAS RETURNED AND ANALYSIS COMPLETED. A 14F WOLF SYSTEM 8MM X 60CM X 110CM WAS RETURNED FOR ANALYSIS. FOUR DEVORTEX SHAFTS WERE RETURNED WITHOUT THE WOLF CATHETER. VISUAL ANALYSIS WAS PERFORMED ON THE FOUR DEVORTEX SHAFTS. NO DAMAGE OR ABNORMALITIES WERE IDENTIFIED TO ANY OF THE FOUR DEVORTEX SLEEVES OR SHAFTS. THE 4 DEVORTEX ALL HAD BIOMATTER WITHIN THEIR SLEEVES. FUNCTIONAL TESTING COULD NOT BE PERFORMED SINCE THE WOLF CATHETER WAS NOT RETURNED FOR ANALYSIS, AND THE 4 DEVORTEX WERE ALREADY USED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A VESSEL PERFORATION OCCURRED. A WOLF VENOUS THROMBECTOMY CATHETER WAS SELECTED FOR USE. TO BEGIN THE PROCEDURE, A VENOGRAM WAS PERFORMED AND IVUS WAS UTILIZED TO CONFIRM CLOT WAS ACUTE AND MEASURE VESSEL SIZE FROM IVC DOWN TO PROXIMAL POPLITEAL-DISTAL SFV (10MM VESSEL). THROUGH THE 14FR WOLF SHEATH, THE PHYSICIAN ADVANCED WOLF CATHETER INTO CLOT AND WAS ABLE TO PULL IN CLOT WITH ABOUT 20CM OF THE SLEEVE. UPON 3RD 1CM ADVANCEMENT, THE PHYSICIAN MET A LOT OF RESISTANCE AND NOTED THAT THE CATHETER WOULD BOUNCE BACKWARDS. THE PHYSICIAN STOPPED AND THEN ATTEMPTED TO PULL ON THE SLEEVE, THINKING HE WAS IN CLOT. HE DID THIS AND ALSO APPLIED FORWARD PRESSURE ON THE CATHETER. ONCE HE FULLY ARTICULATED THE SLEEVE, HE REMOVED FOR INSPECTION AND DID A VENOGRAM WHEN A VESSEL PERFORATION WAS NOTED. HE REWIRED, ADVANCED THE SHEATH PAST THE PERFORATION, AND OPTED TO GO DOWN TO A 6MM FUNNELED WOLF CATHETER. HE DID 2 SUCCESSFUL SLEEVE PULLS UP TO THE COMMON FEM VEIN AND THEN DID A FINAL SLEEVE PULL BACK WITH THE 8MM WOLF CATHETER. NEXT, A WOLF THROMBECTOMY SHEATH WAS SELECTED FOR USE. THREE ASPIRATIONS WERE PERFORMED WITH THE WOLF SHEATH. IT WAS OBSERVED A FEW TIMES THAT THE VACUUM WOULD NOT RELEASE ON THE WOLF SHEATH. AFTER HIS FINAL ASPIRATION, THEY NOTICED AN ABNORMALITY IN THE SHEATH ABOUT 7-10CM AWAY FROM DISTAL TIP. THE WOLF SHEATH WAS REMOVED. AN ANGIOJET ZELANTE AND TWO EKOS CATHETERS WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO FURTHER PATIENT COMPLICATIONS. IT WAS CORRECTED THAT AN ANGIOJET ZELANTE, TWO EKOS CATHETERS, AND A VIABAHN STENT PLACED OVER THE PERFORATION WERE USED TO COMPLETE THE PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A VESSEL PERFORATION OCCURRED. A WOLF VENOUS THROMBECTOMY CATHETER WAS SELECTED FOR USE. TO BEGIN THE PROCEDURE, A VENOGRAM WAS PERFORMED AND IVUS WAS UTILIZED TO CONFIRM CLOT WAS ACUTE AND MEASURE VESSEL SIZE FROM IVC DOWN TO PROXIMAL POPLITEAL-DISTAL SFV (10MM VESSEL). THROUGH THE 14FR WOLF SHEATH, THE PHYSICIAN ADVANCED WOLF CATHETER INTO CLOT AND WAS ABLE TO PULL IN CLOT WITH ABOUT 20CM OF THE SLEEVE. UPON 3RD 1CM ADVANCEMENT, THE PHYSICIAN MET A LOT OF RESISTANCE AND NOTED THAT THE CATHETER WOULD BOUNCE BACKWARDS. THE PHYSICIAN STOPPED AND THEN ATTEMPTED TO PULL ON THE SLEEVE, THINKING HE WAS IN CLOT. HE DID THIS AND ALSO APPLIED FORWARD PRESSURE ON THE CATHETER. ONCE HE FULLY ARTICULATED THE SLEEVE, HE REMOVED FOR INSPECTION AND DID A VENOGRAM WHEN A VESSEL PERFORATION WAS NOTED. HE REWIRED, ADVANCED THE SHEATH PAST THE PERFORATION, AND OPTED TO GO DOWN TO A 6MM FUNNELED WOLF CATHETER. HE DID 2 SUCCESSFUL SLEEVE PULLS UP TO THE COMMON FEM VEIN AND THEN DID A FINAL SLEEVE PULL BACK WITH THE 8MM WOLF CATHETER. NEXT, A WOLF THROMBECTOMY SHEATH WAS SELECTED FOR USE. THREE ASPIRATIONS WERE PERFORMED WITH THE WOLF SHEATH. IT WAS OBSERVED A FEW TIMES THAT THE VACUUM WOULD NOT RELEASE ON THE WOLF SHEATH. AFTER HIS FINAL ASPIRATION, THEY NOTICED AN ABNORMALITY IN THE SHEATH ABOUT 7-10CM AWAY FROM DISTAL TIP. THE WOLF SHEATH WAS REMOVED. AN ANGIOJET ZELANTE AND TWO EKOS CATHETERS WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO FURTHER PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1364529 WOLF THROMBECTOMY SYSTEM PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION QEW DEVORO MEDICAL, INC 0000200069 00850029546030

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention