BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V-14 CONTROL WIRE

    MDR report key: 20798348 · Received November 27, 2024

    Report

    Report Number
    2124215-2024-71409
    Event Type
    Injury
    Date Received
    November 27, 2024
    Date of Event
    June 8, 2023
    Report Date
    December 17, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6 CORRECTION: IMPACT CODE- INTENSIVE CARE REMOVED. E1: INITIAL REPORTER FACILITY NAME- (B)(6). DEWALD, C. L., WACKER, F. K., MAASOUMY, B., & HINRICHS, J. B. (2023). PORTAL VEIN RECANALIZATION-TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (PVR-TIPS) WITH SUPERIOR MESENTERIC VEIN ACCESS AND BALLOON-ASSISTED SHUNT PLACEMENT. CVIR ENDOVASCULAR, 6(33), 1-6. HTTPS://DOI.ORG/10.1186/S42155-023-00379-6.

    Additional Manufacturer Narrative · 0

    E1: INITIAL REPORTER FACILITY NAME- (B)(6). DEWALD, C. L., WACKER, F. K., MAASOUMY, B., & HINRICHS, J. B. (2023). PORTAL VEIN RECANALIZATION-TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (PVR-TIPS) WITH SUPERIOR MESENTERIC VEIN ACCESS AND BALLOON-ASSISTED SHUNT PLACEMENT. CVIR ENDOVASCULAR, 6(33), 1-6. HTTPS://DOI.ORG/10.1186/S42155-023-00379-6.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LITERATURE ARTICLE THAT AN INTERNAL DEVICE BREAK OCCURRED. A V-14 CONTROL WIRE WAS SELECTED FOR USE IN A CASE OF BALLOON-ASSISTED PVR-TIPS USING PERCUTANEOUS ULTRASOUND-GUIDED SUPERIOR MESENTERIC VEIN (SMV) ACCESS TO TREAT PORTAL VEIN (PV) THROMBOSIS. THE STERLING WAS POSITIONED IN THE MAIN STEM OF THE RIGHT PV TO SERVE AS TARGET FOR THE TIPS NEEDLE. THE NEEDLE WAS THEN ADVANCED, AND PUNCTURE WAS ACHIEVED. THE V-14 CONTROL WIRE WAS ADVANCED THROUGH THE NEEDLE AND LOCKED WITHIN THE BALLOON COVER BY DEFLATION OF THE BALLOON. IN ORDER TO ESTABLISH THROUGH AND THROUGH ACCESS, THE BALLOON CATHETER WAS PULLED INTO THE DIRECTION OF THE SMV SHEATH, BUT THE WIRE COULD NOT BE RETRIEVED DUE TO SEVERE KINKING WITHIN THE BALLOON AND EVENTUALLY BROKE. THE DISTAL END OF THE WIRE WAS SECURED THROUGH THE SHEATH. THE 4-FR SHEATH IN THE SMV WAS REPLACED BY A 6-FR SHEATH AND A 6-FR MULTI SNARE CATHETER WAS INSERTED TO SNARE THE WIRE. NONETHELESS, THE PROXIMAL END OF THE WIRE COULD NOT BE RETRIEVED, AND THE WIRE HAD TO BE REMOVED VIA THE JUGULAR ACCESS. NOW WITH THE 6F SHEATH IN PLACE THE MANEUVER WAS REPEATED USING ANOTHER BALLOON CATHETER POSITIONED IN THE RIGHT HEPATIC VEIN AND INFLATED AS FLUOROSCOPIC TARGET. DIRECT TIPS NEEDLE-GUIDED PUNCTURE OF THE BALLOON WAS PERFORMED WITHOUT COMPLICATIONS, AND A NON- BOSTON SCIENTIFIC 0.035 WIRE WAS USED TO SUCCESSFULLY ACHIEVE THROUGH AND THROUGH ACCESS. THE FOLLOWING DAY, COMPUTED TOMOGRAPHY (CT) SHOWED A PATENT TIPS AND NO SIGNS OF INTESTINAL DAMAGE OR INTRAABDOMINAL HEMORRHAGE. CONSECUTIVE ULTRASOUND EXAMS ON THE SUBSEQUENT DAYS WERE ALSO UNREMARKABLE. THE PATIENT SPENT ONE NIGHT IN INTENSIVE CARE AND WAS DISCHARGED FOUR DAYS AFTER THE PROCEDURE. AT THE FIRST FOLLOW-UP ONE MONTH AFTER THE PROCEDURE, THE TIPS WAS PATENT; MOREOVER, NO BLEEDING EPISODE OR SIGNS OF HEPATIC ENCEPHALOPATHY WERE OBSERVED. A SNARE WAS USED TO RETRIEVE THE WIRE; HOWEVER, THE PROXIMAL END OF THE WIRE COULD NOT BE RETRIEVED, AND THE WIRE HAD TO BE REMOVED VIA JUGULAR ACCESS. THE PROCEDURE WAS COMPLETED WITH NEW DEVICES, AND NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LITERATURE ARTICLE THAT AN INTERNAL DEVICE BREAK OCCURRED. A V-14 CONTROL WIRE WAS SELECTED FOR USE IN A CASE OF BALLOON-ASSISTED PVR-TIPS USING PERCUTANEOUS ULTRASOUND-GUIDED SUPERIOR MESENTERIC VEIN (SMV) ACCESS TO TREAT PORTAL VEIN (PV) THROMBOSIS. THE STERLING WAS POSITIONED IN THE MAIN STEM OF THE RIGHT PV TO SERVE AS TARGET FOR THE TIPS NEEDLE. THE NEEDLE WAS THEN ADVANCED, AND PUNCTURE WAS ACHIEVED. THE V-14 CONTROL WIRE WAS ADVANCED THROUGH THE NEEDLE AND LOCKED WITHIN THE BALLOON COVER BY DEFLATION OF THE BALLOON. IN ORDER TO ESTABLISH THROUGH AND THROUGH ACCESS, THE BALLOON CATHETER WAS PULLED INTO THE DIRECTION OF THE SMV SHEATH, BUT THE WIRE COULD NOT BE RETRIEVED DUE TO SEVERE KINKING WITHIN THE BALLOON AND EVENTUALLY BROKE. THE DISTAL END OF THE WIRE WAS SECURED THROUGH THE SHEATH. THE 4-FR SHEATH IN THE SMV WAS REPLACED BY A 6-FR SHEATH AND A 6-FR MULTI SNARE CATHETER WAS INSERTED TO SNARE THE WIRE. NONETHELESS, THE PROXIMAL END OF THE WIRE COULD NOT BE RETRIEVED, AND THE WIRE HAD TO BE REMOVED VIA THE JUGULAR ACCESS. NOW WITH THE 6F SHEATH IN PLACE THE MANEUVER WAS REPEATED USING ANOTHER BALLOON CATHETER POSITIONED IN THE RIGHT HEPATIC VEIN AND INFLATED AS FLUOROSCOPIC TARGET. DIRECT TIPS NEEDLE-GUIDED PUNCTURE OF THE BALLOON WAS PERFORMED WITHOUT COMPLICATIONS, AND A NON- BOSTON SCIENTIFIC 0.035 WIRE WAS USED TO SUCCESSFULLY ACHIEVE THROUGH AND THROUGH ACCESS. THE FOLLOWING DAY, COMPUTED TOMOGRAPHY (CT) SHOWED A PATENT TIPS AND NO SIGNS OF INTESTINAL DAMAGE OR INTRAABDOMINAL HEMORRHAGE. CONSECUTIVE ULTRASOUND EXAMS ON THE SUBSEQUENT DAYS WERE ALSO UNREMARKABLE. THE PATIENT SPENT ONE NIGHT IN INTENSIVE CARE AND WAS DISCHARGED FOUR DAYS AFTER THE PROCEDURE. AT THE FIRST FOLLOW-UP ONE MONTH AFTER THE PROCEDURE, THE TIPS WAS PATENT; MOREOVER, NO BLEEDING EPISODE OR SIGNS OF HEPATIC ENCEPHALOPATHY WERE OBSERVED. A SNARE WAS USED TO RETRIEVE THE WIRE; HOWEVER, THE PROXIMAL END OF THE WIRE COULD NOT BE RETRIEVED, AND THE WIRE HAD TO BE REMOVED VIA JUGULAR ACCESS. THE PROCEDURE WAS COMPLETED WITH NEW DEVICES, AND NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2383969 V-14 CONTROL WIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Required Intervention