BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLOSUREFAST CATHETER

    MDR report key: 23877640 · Received December 23, 2025

    Report

    Report Number
    2183870-2025-00598
    Event Type
    Injury
    Date Received
    December 23, 2025
    Date of Event
    April 25, 2025
    Report Date
    December 23, 2025
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    PMA / PMN Number
    K111887
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ACUTE PULMONARY EMBOLISM WITH INFERIOR VENA CAVAL THROMBUS FOLLOWING RADIOFREQUENCY ABLATION OF THE GREAT SAPHENOUS VEIN DESPITE EARLY ULTRASOUND SURVEILLANCE 025 THE AUTHOR(S). PUBLISHED BY ELSEVIER INC. ON BEHALF OF SOCIETY FOR VASCULAR SURGERY. THIS IS AN OPEN ACCESS ARTICLE UNDER THE CC BY LICENSE (HTTP:// CREATIVECOMMONS.ORG/LICENSES/BY/4.0/). HTTPS://DOI.ORG/10.1016/J.JVSCIT.2025.101825 B3 DATE OF PUBLICATION 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

    A 69-YEAR-OLD WOMAN PRESENTED WITH SYMPTOMATIC RIGHT LEG VARICOSE VEINS. HER SYMPTOMS INCLUDED PAIN, ACHING, HEAVINESS, AND EDEMA (CLINICAL ETIOLOGICAL ANATOMICAL PHYSIOLOGICAL CLINICAL CLASS 3). HER SYMPTOMS WERE PRESENT FOR MANY YEARS, AND SHE WAS COMPLIANT WITH COMPRESSION STOCKINGS FOR THE PAST YEAR. HER SYMPTOMS INTERFERED WITH PROLONGED STANDING, EXERCISE, AND OTHER ACTIVITIES OF DAILY LIVING. HER MEDICAL HISTORY WAS SIGNIFICANT FOR INVASIVE DUCTAL CARCINOMA OF THE RIGHT BREAST (STAGE III, T1A, N0, ESTROGEN RECEPTOR POSITIVE) TREATEDWITH LUMPECTOMY AND RADIATION 7 YEARS PRIOR. SHE WASMONITORED YEARLY AND CANCER-FREE SINCE HER LUMPECTOMY. SHE HADNO PRIOR HISTORY OF PHLEBITIS OR DVT. HER FAMILY HISTORY WAS NEGATIVE FOR ANY KNOWN HYPERCOAGULABLE DISORDERS. SHE HAD A 30 PACK-YEAR SMOKING HISTORY, BUT QUIT 20 YEARS PRIOR. MEDICATIONS INCLUDED AN ETONOGESTREL/ETHINYL ESTRADIOL-SECRETING VAGINAL RING (0.120 MG/ 0.015 MG/DAY) CHANGED MONTHLY, PRESCRIBED BY PER PRIMARY CARE PHYSICIAN FOR INCONTINENCE AND VAGINAL DRYNESS.4 SHE ALSO TOOK LEVOTHYROXINE (SYNTHROID) 75 MG/DAY. HER BODY MASS INDEX WAS 31 KG/M2 . ON PHYSICAL EXAMINATION, SHE HAD SUPERFICIAL VARICOSITIES, MOST PROMINENT ON THE RIGHT MEDIAL THIGH, AND RIGHT ANKLE EDEMA. A PREPROCEDURAL DUPLEX ULTRASOUND DEMONSTRATED AN INCOMPETENT RIGHT SAPHEN OFEMORAL JUNCTION (SFJ) WITH 3 SECONDS OF REFLUX (FIG 1, A). HER GSV DIAMETER MEASURED 20 MM IMMEDIATELY CAUDAL TO THE SFJ AND UPPER THIGH AND 10 MM IN THE MID-THIGH (FIG 1, B). A 5-MM ANTERIOR SUPERFICIAL TRIBUTARY VEIN BRANCHED IN THE DISTAL THIGH AND BECAME ANA TOMICALLY SUPERFICIAL. CAUDAL TO THIS POINT, THE GSV BECAME SMALL (3 MM) TO THE LEVEL OF THE DISTAL CALF. RIGHT COMMON FEMORAL VEIN (CFV) REFLUX (>0.5 SECONDS) WAS ALSO PRESENT. RFA OF THE RIGHT GSV WAS PERFORMED IN THE AMBULATORY PROCEDURE UNIT UNDER LOCAL ANESTHESIA. ULTRASOUND-GUIDED PERCUTANEOUS ACCESS WAS OBTAINED IN THE DISTAL THIGH, WHERE THE GSV BRANCHED WITH A MICROPUNCTURE NEEDLE AND WIRE. A 7F SHEATH WAS INSERTED INTO THE GSV OVER THE WIRE. A 7F CLOSUREFAST RFA CATHETER (MEDTRONIC, MINNEAPOLIS, MN) WITH A 7-CM TREATMENT LENGTH WAS ADVANCED INTO THE GSV, AND ITS TIP WAS SECURED 2.5 CM CAUDAL TO THE SFJ. A SPINAL NEEDLE WAS USED TO INJECT A TUMESCENT SOLUTION (NORMAL SALINE, 500 ML: 1% LIDOCAINE 50 ML: SODIUM BICARBONATE 5 ML) INTO THE PERIVENOUS TISSUE SURROUNDING THE GSV. APPROXIMATELY 100 ML OF TOTAL TUMESCENT SOLUTION WAS USED. THE DISTANCE OF THE CATHETER FROM THE SFJ WAS CONFIRMED WITH ULTRASOUND BEFORE AND AFTER THE TUMESCENCE INJECTION AND COLLAPSE OF THE VEIN AROUND THE CATHETER WAS CONFIRMED PRIOR TO RFA. TWO 20-SECOND TREATMENTS AT 120 CELSIUS WERE PERFORMED IN THE GSV SEGMENT 2.5 CM CAUDAL TO THE SFV. THE CATHETER WAS THEN WITHDRAWN 7 CM, AND TWO ADDITIONAL 20-SECOND TREATMENTS WERE PERFORMED AT THIS LEVEL. THE SHEATH AND CATHETER WERE REMOVED, AND THE LEG WAS COMPRESSED. SHE TOLERATED THE PROCEDURE WITHOUT DIFFICULTY. THE DURATION OF THE PROCEDURE WAS 35MINUTES. PER PATIENT WISH, NO CONCOMITANT PROCEDURES (IE, PHLEBECTOMY, SCLEROTHERAPY) WERE PERFORMED. THE PATIENT RETURNED 2 DAYS LATER FOR A ROUTINE POSTPROCEDURE DUPLEX ULTRASOUND EXAMINATION TO RULE OUT ARTE AND ENSURE GSV CLOSURE. SHE WAS ASYMPTOMATIC. THE ULTRASOUND PERFORMED BY AN ULTRASOUND TECHNICIAN IN OUR ACCREDITED VASCULAR LABORATORY DEMONSTRATED SUCCESSFUL CLOSURE OF THE RIGHT GSV FROM THE SFJ TO THE DISTAL THIGH AND A PATENT CFV WITH NO EVIDENCE OF ARTE OR DVT (FIG 2). A COMPLETE ULTRASOUND STUDY WAS PERFORMED AND DEMONSTRATED NO EVIDENCE OF INFRAINGUINAL DVT FROM THE GROIN TO THE ANKLE. THE PATIENT WAS INSTRUCTED TO AMBULATE AS TOLERATED, AND THE PATIENT WAS WEARING POSTPROCEDURE COMPRESSION WITH COMPLIANCE PER THE GUIDELINES OF THE SOCIETY FOR VASCULAR SURGERY AND THE AMERICAN VENOUS FORUM. FIVE DAYS LATER, SHE PRESENTED TO OUR CLINIC WITH SHORTNESS OF BREATH AND COUGH, WHICH DEVELOPED 1 DAY AFTER HER INITIAL DUPLEX ULTRASOUND EXAMINATION A ND WAS PERSISTENT FOR 4 DAYS. SHE WAS TACHYPNEIC AND WAS NOTED TO HAVE 98% OXYGEN SATURATION ON ROOM AIR. A REPEAT DUPLEX ULTRASOUND EXAMINATION DEMONSTRATED ARTE IN THE CFV (FIG 3). SHE WAS SENT IMMEDIATELY TO THE EMERGENCY ROOM FOR A HIGHER LEVEL OF CARE. A HEPARIN BOLUS (71 MG/KG) WAS ADMINISTERED, AND A HEPARIN DRIP WAS TITRATED TO A GOAL PARTIAL THROMBOPLASTIN TIME OF 50 TO 80 SECONDS. CO MPUTED TOMOGRAPHY ANGIOGRAPHY DEMONSTRATED ACUTE MULTIFOCAL BILATERAL PE (FIG 4). THROMBUS BURDEN IN THE INFERIOR VENA CAVA EXTENDING INTO THE RIGHT ATRIUM WAS ALSO VISUALIZED (FIG 5). HER HORMONAL THERAPY WAS DISCONTINUED. TRANSTHORACIC ECHOCARDIOGRAM DEMONSTRATED MILD RIGHT ATRIAL ENLARGEMENT WITH NO EVIDENCE OF RIGHT HEART STRAIN AND A NORMAL EJECTION FRACTION. HER TACHYPNEA IMPROVED SIGNIFICANTLY WITH SYSTEMIC ANTICOAGULATION, AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE. THUS, THROMBOLYSIS AND ASPIRATION THROMBECTOMY WERE NOT PERFORMED. THE HEMATOLOGY SERVICE WAS CONSULTED, AND AN EXTENSIVE HYPERCOAGULABLE WORKUP WAS CONDUCTED, WHICH WAS NEGATIVE. MAGNETIC RESONANCE VENOGRAPHY OF THE CHEST WAS PERFORMED ON HOSPITAL DAY 3, AND PERSISTENT BILATERAL PULMONARY EMBOLI WERE DEMONSTRATED, BUT THERE WAS RESTORATION OF PATENCY AND RESOLUTION OF THROMBUS IN THE IVC. THE PATIENT WAS DISCHARGED HOME ON HOSPITAL DAY 4 AND TRANSITIONED TO ORAL COUMADIN BRIDGED WITH ENOXAPARIN SODIUM (LOVENOX). AT HER 6-MONTH FOLLOW-UP VISIT, SHE WAS ASYMPTOMATIC. REPEAT COMPUTED TOMOGRAPHY ANGIOGRAPHY 6 MONTHS LATER DEMONSTRATED RESOLUTION OF HER BILATERAL PES. HER ORAL ANTICOAGULATION WAS DISCONTINUED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2476234 CLOSUREFAST CATHETER ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI COVIDIEN UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Required Intervention