BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VORTEX

    MDR report key: 13577585 · Received February 22, 2022

    Report

    Report Number
    13577585
    Event Type
    Injury
    Date Received
    February 22, 2022
    Date of Event
    November 16, 2021
    Report Date
    February 7, 2022
    Manufacturer
    NAVILYST MEDICAL, INC.
    Product Code
    LJT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHEN SURGEON WENT TO REMOVE THE VORTEX MP TITANIUM LOW-PROFILE PORT SYSTEM, THE CATHETER PORTION BROKE APART. THE BREAKING OF THE SILICONE CATHETER OCCURRED AS THE SURGEON ATTEMPTED TO PULL IT OUT. THE SURGEON'S OPERATIVE NOTE DESCRIBES THE INCIDENT: "THE THREE ANCHORING PROLENE SUTURES WERE DIVIDED AND REMOVED. THE PORT WAS TAKEN OUT OF ITS SUBCUTANEOUS POCKET. THE CATHETER HAD ROUGH SURFACE. WITH TRACTION THE CATHETER CAME OUT OF THE TUNNEL BUT IT FRACTURED IN THE SUBCLAVICULAR AREA AND ONLY THE PORTION FROM THE TUNNEL CAME OUT. WE HAD A RETAINED INTRAVASCULAR CATHETER FRAGMENT. THERE WAS NO BLEEDING FROM THE SITE. C-ARM WAS USED, AND THE CATHETER WAS FOUND TO BE FRACTURED AT THE MIC-CLAVICLE LEVEL¿TOO DEEP TO EXPLORE FROM A SUBCLAVIAN APPROACH. CATHETER SEEMED TO BE IN A STABLE POSITION." THE SURGICAL WOUND WAS THEN CLOSED. SURGEON THEN DISCUSSED THE CASE WITH INTERVENTIONAL RADIOLOGIST (IR). IR AGREED TO TAKE THE CHILD FOR ENDOVASCULAR RETRIEVAL OF THE FRAGMENT. USING RIGHT FEMORAL ARTERY APPROACH, THE FOREIGN BODY WAS RETRIEVED USING A SNARE. PATIENT RECOVERED AND WENT HOME LATER THAT EVENING.

    Description of Event or Problem · 0

    WHEN SURGEON WENT TO REMOVE THE VORTEX MP TITANIUM LOW-PROFILE PORT SYSTEM, THE CATHETER PORTION BROKE APART. THE BREAKING OF THE SILICONE CATHETER OCCURRED AS THE SURGEON ATTEMPTED TO PULL IT OUT. THE SURGEON'S OPERATIVE NOTE DESCRIBES THE INCIDENT: "THE THREE ANCHORING PROLENE SUTURES WERE DIVIDED AND REMOVED. THE PORT WAS TAKEN OUT OF ITS SUBCUTANEOUS POCKET. THE CATHETER HAD ROUGH SURFACE. WITH TRACTION THE CATHETER CAME OUT OF THE TUNNEL BUT IT FRACTURED IN THE SUBCLAVICULAR AREA AND ONLY THE PORTION FROM THE TUNNEL CAME OUT. WE HAD A RETAINED INTRAVASCULAR CATHETER FRAGMENT. THERE WAS NO BLEEDING FROM THE SITE. C-ARM WAS USED, AND THE CATHETER WAS FOUND TO BE FRACTURED AT THE MIC-CLAVICLE LEVEL¿TOO DEEP TO EXPLORE FROM A SUBCLAVIAN APPROACH. CATHETER SEEMED TO BE IN A STABLE POSITION." THE SURGICAL WOUND WAS THEN CLOSED. SURGEON THEN DISCUSSED THE CASE WITH INTERVENTIONAL RADIOLOGIST (IR). IR AGREED TO TAKE THE CHILD FOR ENDOVASCULAR RETRIEVAL OF THE FRAGMENT. USING RIGHT FEMORAL ARTERY APPROACH, THE FOREIGN BODY WAS RETRIEVED USING A SNARE. PATIENT RECOVERED AND WENT HOME LATER THAT EVENING.

    Description of Event or Problem · 0

    WHEN SURGEON WENT TO REMOVE THE VORTEX MP TITANIUM LOW-PROFILE PORT SYSTEM, THE CATHETER PORTION BROKE APART. THE BREAKING OF THE SILICONE CATHETER OCCURRED AS THE SURGEON ATTEMPTED TO PULL IT OUT. THE SURGEON'S OPERATIVE NOTE DESCRIBES THE INCIDENT: "THE THREE ANCHORING PROLENE SUTURES WERE DIVIDED AND REMOVED. THE PORT WAS TAKEN OUT OF ITS SUBCUTANEOUS POCKET. THE CATHETER HAD ROUGH SURFACE. WITH TRACTION THE CATHETER CAME OUT OF THE TUNNEL BUT IT FRACTURED IN THE SUBCLAVICULAR AREA AND ONLY THE PORTION FROM THE TUNNEL CAME OUT. WE HAD A RETAINED INTRAVASCULAR CATHETER FRAGMENT. THERE WAS NO BLEEDING FROM THE SITE. C-ARM WAS USED, AND THE CATHETER WAS FOUND TO BE FRACTURED AT THE MIC-CLAVICLE LEVEL¿TOO DEEP TO EXPLORE FROM A SUBCLAVIAN APPROACH. CATHETER SEEMED TO BE IN A STABLE POSITION." THE SURGICAL WOUND WAS THEN CLOSED. SURGEON THEN DISCUSSED THE CASE WITH INTERVENTIONAL RADIOLOGIST (IR). IR AGREED TO TAKE THE CHILD FOR ENDOVASCULAR RETRIEVAL OF THE FRAGMENT. USING RIGHT FEMORAL ARTERY APPROACH, THE FOREIGN BODY WAS RETRIEVED USING A SNARE. PATIENT RECOVERED AND WENT HOME LATER THAT EVENING.

    Description of Event or Problem · 0

    WHEN SURGEON WENT TO REMOVE THE VORTEX MP TITANIUM LOW-PROFILE PORT SYSTEM, THE CATHETER PORTION BROKE APART. THE BREAKING OF THE SILICONE CATHETER OCCURRED AS THE SURGEON ATTEMPTED TO PULL IT OUT. THE SURGEON'S OPERATIVE NOTE DESCRIBES THE INCIDENT: "THE THREE ANCHORING PROLENE SUTURES WERE DIVIDED AND REMOVED. THE PORT WAS TAKEN OUT OF ITS SUBCUTANEOUS POCKET. THE CATHETER HAD ROUGH SURFACE. WITH TRACTION THE CATHETER CAME OUT OF THE TUNNEL BUT IT FRACTURED IN THE SUBCLAVICULAR AREA AND ONLY THE PORTION FROM THE TUNNEL CAME OUT. WE HAD A RETAINED INTRAVASCULAR CATHETER FRAGMENT. THERE WAS NO BLEEDING FROM THE SITE. C-ARM WAS USED, AND THE CATHETER WAS FOUND TO BE FRACTURED AT THE MIC-CLAVICLE LEVEL¿TOO DEEP TO EXPLORE FROM A SUBCLAVIAN APPROACH. CATHETER SEEMED TO BE IN A STABLE POSITION." THE SURGICAL WOUND WAS THEN CLOSED. SURGEON THEN DISCUSSED THE CASE WITH INTERVENTIONAL RADIOLOGIST (IR). IR AGREED TO TAKE THE CHILD FOR ENDOVASCULAR RETRIEVAL OF THE FRAGMENT. USING RIGHT FEMORAL ARTERY APPROACH, THE FOREIGN BODY WAS RETRIEVED USING A SNARE. PATIENT RECOVERED AND WENT HOME LATER THAT EVENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799625 VORTEX PORT CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LJT NAVILYST MEDICAL, INC. MP-P5SAT 5128249

    Patients

    Seq Age Sex Outcome Treatment
    1 1460 DA Female Hospitalization| R| O