VenaSeal™ VS-402Recalls & reported problems

Summary

The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 00643169986268), received between Mar 16, 2018 and Jul 26, 2024 — classified as 2 deaths, 58 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (17 reports).

1 FDA recall record name this device's identifier.

1 other recall cover devices cleared under the same FDA submission (P140018); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Mar 23, 2021Terminated

   Firm received increased number of reports that VenaSeal dispensing systems are not effectively advancing the adhesive forward through the delivery catheter.

   Z-1564-2021 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 65 reports, in the reporter's own words as published by the FDA.

• InjuryJul 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE A VENASEAL WAS USED TO TREAT THE GREAT SAPHENOUS VEIN. APPROXIMATELY 3 WEEKS POST PROCEDURE PATIENT SUFFERED BACTEREMIA. PRESENTED WITH BACTEREMIA AND FEVER. CULTURES, LABS AND IMAGING OBTAINED. THE EVENT WAS TREATED HOSPITALIZATION/MEDICATION. PATIENT RECOVERED.

  Patient problems: Bacteremia

  MAUDE report 19836223 ↗
• InjuryNov 30, 2023Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE ONE VENASEAL CLOSURE SYSTEM WAS USED TO TREAT A LESION LOCATED IN THE GREAT SAPHENOUS VEIN (GSV) 1, SMALL SAPHENOUS VEIN (SSV). APPROXIMATELY 28 MONTHS POST PROCEDURE PATIENT SUFFERED LEFT SMALL SAPHENOUS VEIN REFLUX. IT WAS REPORTED THAT PATIENT HAD SIGNIFICANT PAIN IN THE LEFT LEG, CONTINUED LEG EDEMA, HYPERPIGMENTATION AND LYMPHEDEMA LEAKING.  DUPLEX ULTRASOUND SHOWED BILATERAL DEEP SYSTEM REFLUX ON THE LEFT FROM MID THIGH TO THE JUNCTION AT THE LEFT GSV AND LEFT SSV REFLUX. THE EVENT WAS TREATED WITH ENDOVENOUS VENASEAL CLOSURE OF THE LEFT SSV. IT WAS STATED THAT THE EVENT IS RELATED TO TARGET LIMB/VEIN. PATIENT RECOVERED.

  Patient problems: Hyperpigmentation; Pain; Swelling/ Edema; Swollen Lymph Nodes/Glands; Valvular Insufficiency/ Regurgitation

  MAUDE report 18236095 ↗
• MalfunctionNov 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PHYSICIAN USED A VENASEAL CLOSURE SYSTEM TO TREAT A PATIENT¿S GREAT SAPHENOUS VEIN (GSV). PATIENT PRESENTED FOR 6 MONTH STUDY REQUIRED ULTRASOUND. A DUPLEX ULTRASOUND WAS PERFORMED ON (B)(6) 2022 AND TECHNICIAN NOTED CLINICALLY INSIGNIFICANT ENDOTHERMAL GLUE INDUCED EXTENSION. PATIENT WAS ASYMPTOMATIC AND NO TREATMENT WAS WARRANTED. THE INVESTIGATOR ASSESSED THE EVENT AS CAUSALLY RELATED TO THE INDEX DEVICE OR PROCEDURE. THE SPONSOR ASSESSED THE EVENT AS NOT RELATED TO PROCEDURE AND CAUSALLY RELATED TO THE DEVICE. ISSUE RESOLVED ON (B)(6) 2022.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 18189440 ↗
• DeathJan 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE ONE VENASEAL CLOSURE SYSTEM WAS USED TO TREAT A LESION LOCATED IN THE POSTERIOR ACCESSORY SAPHENOUS VEIN. APPROXIMATELY 13 MONTHS POST PROCEDURE THE PATIENT DIED.

  Patient problems: Insufficient Information; Septic Shock

  MAUDE report 16136594 ↗
• InjuryDec 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE VENASEAL CLOSURE SYSTEM WAS USED TO TREAT A LESION LOCATED IN THE GREAT SAPHENOUS VEIN 1. APPROXIMATELY 1 MONTH POST PROCEDURE THE PATIENT SUFFERED FROM A FLARE UP OF EDEMA, DISCOMFORT AND SWELLING IN THE LEFT KNEE. THE PATIENT WENT TO THE ER AND WAS PRESCRIBED MEDICATION. IT WAS STATED THAT THE EVENT IS RELATED TO TARGET LIMB BUT NOT RELATED TO THE TARGET VEIN. THE PATIENT RECOVERED.

  Patient problems: Discomfort; Swelling/ Edema; Vasculitis

  MAUDE report 16012485 ↗
• InjuryDec 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PHYSICIAN USED THE VENASEAL CLOSURE SYSTEM TO TREAT THE PATIENT¿S LEFT GREAT SAPHENOUS VESSEL (GSV). LOCAL ANESTHESIA WAS USED. THE LUMEN WAS FLUSHED PRIOR TO USE AND A GUIDEWIRE WAS USED FOR INSERTION OF THE CATHETER. IFU WAS FOLLOWED. COMPRESSION WAS NOT USED POST PROCEDURE. THE VEIN WAS CLOSED. IT WAS REPORTED THAT AN ADVERSE EVENT OCCURRED AFTER THE VENASEAL WAS IMPLANTED. AT FOLLOW-UP 4 DAYS AFTER IMPLANT, NO DVT WAS NOTED. EGIT 1 WAS DOCUMENTED. PATIENT PRESENTED TO THE ED 8 DAYS POST IMPLANT C/O PAIN WITH DEEP INSPIRATION. CT WAS DONE 9 DAYS AFTER IMPLANT AND PULMONARY EMBOLISM (PE) NOTED. VENOUS DUPLEX DONE 9 DAYS AFTER IMPLANT, NO DVT NOTED. THE PHYSICIAN HAS RULED OUT DEEP VEIN THROMBOSIS IN THE PATIENT'S LEGS TWICE. NO CLOT EXTENSION INTO THE JUNCTION, BUT IT IS UNCLEAR IF IT WAS THE SFJ OR SPJ. THERE IS AN EGIT 1 NOTED, SUPERFICIAL CLOT. THE PATIENT IS ALIVE AND DIAGNOSED WITH A PULMONARY EMBOLISM (PE).

  Patient problems: Pain; Pulmonary Embolism; Thrombosis/Thrombus

  MAUDE report 13008886 ↗
• InjuryDec 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE A VENASEAL CLOSURE SYSTEM WAS USED TO TREAT A LESION LOCATED IN THE SMALL SAPHENOUS VEIN. APPROXIMATELY 5 WEEKS POST PROCEDURE PATIENT SUFFERED FROM THROMBOPHLEBITIS OF THE TARGET VEIN. THE PATIENT WAS TREATED WITH MANUAL EXPRESSION OF THE CLOTS AND A MEDICATION CHANGE. IT WAS STATED THAT THE EVENT IS RELATED TO TARGET LIMB/VEIN. PATIENT HAS NOT RECOVERED.

  Patient problems: Discomfort; Swelling/ Edema; Thrombosis/Thrombus; Vasculitis

  MAUDE report 12966990 ↗
• InjuryOct 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE ONE VENASEAL CLOSURE SYSTEM WAS USED TO TREAT A LESION LOCATED IN THE GREAT SAPHENOUS VEIN 1. APPROXIMATELY 4 DAYS POST PROCEDURE PATIENT SUFFERED FROM SEPTIC SHOCK. THE PATIENT WAS TREATED WITH MEDICATION. IT WAS STATED THAT THE EVENT IS NOT RELATED TO TARGET LIMB.

  Patient problems: Septic Shock; Unspecified Infection

  MAUDE report 12560152 ↗
• InjuryAug 10, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PHYSICIAN USED VENASEAL FOR PATIENT TREATMENT OF THE GREAT SAPHENOUS VEIN (GSV). TRANSDUCER COMPRESSION WAS USED. IFU WAS FOLLOWED. ONE SEGMENT WAS TREATED. THE VEIN WAS REPORTED TO HAVE CLOSED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED HYPERSENSITIVITY REACTION POST-PROCEDURE. THE PATIENT HAD A "BAD" TYPE 4 DELAYED HYPERSENSITIVITY FOLLOWING THE PROCEDURE. IT WAS REPORTED 6 DAYS AFTER, THE PATIENT EXPERIENCED SYMPTOMS. 12 DAYS AFTER, THE PATIENT HAD ANGIOEDEMA AND HAD TO GO TO THE EMERGENCY DEPARTMENT. THE PATIENT RECEIVED IV STEROID AND WAS DISCONNECTED WITH PREDNISONE ORAL MEDICATION. THE PATIENT IS FEELING BETTER AND DECIDED TO BE MONITORED FOR NOW. THE PATIENT IS EXPECTED FOR A FOLLOW UP WITH THE ALLERGIST.

  Patient problems: Hypersensitivity/Allergic reaction; Swelling/ Edema

  MAUDE report 12300685 ↗
• InjuryAug 4, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  PATIENT UNDERWENT A VENASEAL PROCEDURE GREAT SAPHENOUS VEIN (GSV). THE PROCEDURE WAS COMPLETED AS PER THE IFU. ON THE DAY OF THE PROCEDURE THE PATIENT PRESENTED WITH AN ACTIVE VENOUS ULCER. LOCATION WAS JUST ABOVE THE RIGHT ANKLE. THE PHYSICIAN GAINED ACCESS TO THE GSV JUST ABOVE THE SITE OF THE ULCER AND SUCCESSFULLY TREATED A 32-34CM LENGTH OF VEIN. THE PLAN WAS TO SHUT OFF THE PRESSURE OF THE GSV ABOVE THE ULCER TO HELP IN THE HEALING OF THAT AREA OF THE PATIENT¿S RIGHT LEG. IT HAS BEEN REPORTED 5 MONTHS POST PROCEDURE, GLUE (OR GLUE-LIKE CLEAR SUBSTANCE) IS BEING PUSHED FROM THE PATIENT'S VEIN TO THE OUTSIDE OF THE BODY ALONG THE TRACK OF THE VEIN THAT WAS TREATED. PATIENT IS NOT EXPERIENCING ANY PAIN ASSOCIATED WITH THIS EVENT. NO ADDITIONAL TREATMENT REQUIRED.

  Patient problems: Foreign Body Reaction; Granuloma; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12273671 ↗
• InjuryJul 7, 2021Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  PHYSICIAN USED VENASEAL OCCLUDING DEVICE DURING PROCEDURE TO TREAT A SEGMENT IN THE GREAT SAPHENOUS VEIN (GSV). LOCAL ANESTHESIA WAS USED. TRANSDUCER WAS USED FOR COMPRESSION. THE LUMEN WAS FLUSHED PRIOR TO USE. IFU WAS FOLLOWED. A GUIDEWIRE WAS USED FOR THE INSERTION OF THE CATHETER. PHYSICIAN REPORTED "ONE OF MY PATIENTS HAD VENASEAL PROCEDURE AND HAD DELAYED HYPERSENSITIVITY REACTION WITH REDNESS AND SWELLING OF RIGHT LEG." PHYSICIAN GAVE MEDTROL DOSEPAK 8 DAYS LATER AND PATIENT FINISHED 5 DAYS LATER. PATIENT DEVELOPED ITCHING, HIVES AND HEAD SWELLING, 2 WEEKS POST PROCEDURE. PATIENT WAS SEEN IN ER AND GIVEN EPI INJECTION AND DISCHARGED ON PO STEROIDS. THE PROCEDURE WAS COMPLETED NORMALLY. PATIENT REACTION OCCURRED POST-OP. THE VEIN CLOSED. APPROXIMATELY ONE MONTH POST PROCEDURE, PATIENT RETURNED FOR FOLLOW UP. PHYSICIAN REPORTED PATIENT IS DOING BETTER BUT STILL ON PREDNISONE. PHYSICIAN STATED HAS NO PRIOR ALLERGIES. NO FURTHER INJURY REPORTED.

  Patient problems: Hypersensitivity/Allergic reaction; Local Reaction; Swelling/ Edema

  MAUDE report 12128412 ↗
• InjuryJun 23, 2021Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN USED A VENASEAL CLOSURE SYSTEM TO TREAT A PATIENT¿S GREAT SAPHENOUS VEIN (GSV) AND SHORT SAPHENOUS VEIN (SSV). THE RIGHT LEG WAS INITIALLY TREATED, FOLLOWED BY THE LEFT 1 DAY LATER. THE IFU WAS NOT FOLLOWED, DID NOT USE BLUE SHEATH. NO GUIDEWIRE USED FOR THE INSERTION OF THE CATHETER. NO COMPRESSION USED. TUMESCENT INFILTRATION WAS NOT UTILIZED. LOCAL ANAESTHESIA WAS USED. THERE WERE NO ISSUES DURING PROCEDURE. 2 SEGMENTS WERE TREATED, AND THE VEIN IS REPORTED TO HAVE CLOSED. IT IS REPORTED THE PATIENT EXPERIENCED PAIN AROUND THE TREATED AREAS AFTER SIX MONTHS, NONE EXISTED BEFORE THEN. NO ADDITIONAL TREATMENT WAS CONDUCTED. ONE MONTH LATER THE PATIENT CAME IN FOR THEIR FOLLOW UP APPOINTMENT AND THE RIGHT SSV MIDCALF AND THE LEFT GSV PROXIMAL THIGH WERE OF CONCERN. THE PATIENT WAS COMPLAINING OF LEG PAIN AND KNOTS IN THESE AREAS. ADDITIONAL INFORMATION RECEIVED INDICATES THE PATIENT THE PATIENT IS IN NO PAIN AND DOES NOT REQUIRE ANY FURTHER TREATMENT. POST PROCEDURAL IMAGES WERE RECEIVED WHICH REVEALED MASSES WHICH MAY BE A FOREIGN BODY GRANULOMA FORMATION, OR A MIXED ECHOGENICITY FLUID FILLED MASS.

  Patient problems: Granuloma; Pain

  MAUDE report 12049038 ↗
• InjuryJun 18, 2021Biocompatibility; Biocompatibility

  PATIENT RECEIVED VENASEAL TREATMENT TO TREAT A LESION IN THE RIGHT LEG GREAT SAPHENOUS VEIN (GSV). NO ISSUES NOTED DURING THE PROCEDURE. POST PROCEDURE THE PATIENT PRESENTED WITH A HYPERSENSITIVITY REACTION. THE PATIENT HAD SYMPTOMS OF REDNESS, ITCHINESS, AND INFLAMMATION. THE PATIENT WAS PRESCRIBED A SOLU-MEDROL DOSE PACK FOR 1 WEEK TAPERED DOWN. THE PATIENT IS REPORTED TO BE DOING GOOD NOW. NO FURTHER INJURY REPORTED.

  Patient problems: Hypersensitivity/Allergic reaction; Inflammation; Local Reaction

  MAUDE report 12023740 ↗
• InjuryMay 18, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  VENASEAL WAS USED FOR TREATMENT OF THE GREAT SAPHENOUS VEIN (GSV). THE PROCEDURE WAS COMPLETED AS PER IFU WITHOUT ANY ISSUES NOTED. THE VEIN IS REPORTED TO HAVE CLOSED. APPROXIMATELY 25 DAYS POST IMPLANT IRRITATION IS PRESENT NEAR THE ACCESS POINT. A HYPERSENSITIVITY REACTION IS PRESENT OVER THE TREATED VEIN SEGMENT. THE PATIENT¿S HYPERSENSITIVITY REACTION HAS PERSISTED FOR OVER 9 WEEKS POST IMPLANT. THE PATIENT WAS PRESCRIBED ONE COURSE OF TAPERED ORAL STEROIDS WHICH HELPED BUT DID NOT RESOLVE THE ISSUE. THE PHYSICIAN WAS RECOMMENDED TO CONTINUE THE STEROIDS FOR 3 CYCLES AS WELL AS USE OF TRIAMCINOLONE (STEROID) CREAM TO THE LOCAL AREA. NO FURTHER INJURY REPORTED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 11841576 ↗
• DeathMay 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN INDEX PROCEDURE A IN A CLINICAL STUDY A VENASEAL CLOSURE SYSTEM WAS USED TO TREAT A LESION LOCATED IN THE SAPHENOUS VEIN. POST PROCEDURE THE PATIENT EXITED THE STUDY PER PHYSICIAN DECISION. IT IS REPORTED THAT THE PATIENT DIED AFTER STUDY EXIT. AS THE PATIENT HAD EXITED THE STUDY NO DETAILS OF THE PATIENT DEATH CAN BE COLLECTED. THE CAUSE OF DEATH IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 11824220 ↗
• InjuryMay 11, 2021Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE A VENA SEAL CLOSURE SYSTEM WAS USED TO TREAT A LESION LOCATED IN THE GREAT SAPHENOUS VEIN 1. APPROXIMATELY 18 DAYS POST PROCEDURE, PATIENT SUFFERED FROM HYPERSENSITIVITY ON TARGET LIMB, WHICH WAS NOTED FROM THE CREASE ON THE KNEE THROUGH THE UPPER THIGH ON THE TREATED LEG. THE EVENT WAS TREATED WITH PRESCRIBED MEDICATION. PATIENT HAS NOT RECOVERED.

  Patient problems: Hypersensitivity/Allergic reaction; Vasculitis

  MAUDE report 11804969 ↗
• InjuryMay 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE A VENA SEAL CLOSURE SYSTEM WAS USED TO TREAT A LESION LOCATED IN THE GREAT SAPHENOUS VEIN 1. APPROXIMATELY FIVE DAYS POST PROCEDURE, PATIENT SUFFERED FROM A PHLEBITIS, CELLULITIS WHICH WAS NOTED OVER THE RIGHT THIGH. IT WAS STATED THAT THE EVENT WAS RELATED TO TARGET LIMB AND TO TARGET VEIN (GREAT SAPHENOUS VEIN 1). THE PHLEBITIS STEMMING FROM THE TARGET VEIN LED TO SEPTIC SHOCK. THE EVENT WAS TREATED WITH INTERVENTION INVOLVING TARGET VEIN, ANTIBIOTICS AND OXYGEN. PATIENT HAS NOT RECOVERED.

  Patient problems: Cellulitis; Septic Shock; Vasculitis

  MAUDE report 11768308 ↗
• InjuryApr 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE A VENA SEAL CLOSURE SYSTEM WAS USED TO TREAT A LESION LOCATED IN THE GREAT SAPHENOUS VEIN 1. APPROXIMATELY SIX DAYS POST PROCEDURE, PATIENT SUFFERED SEPTIC SHOCK. IT WAS STATED THAT THE EVENT WAS RELATED TO TARGET LIMB / VEIN (GREAT SAPHENOUS VEIN 1). THE PATIENT WAS HOSPITALIZED AND TREATED WITH MEDICATION AND INTERVENTION INVOLVING THE TARGET LIMB/VEIN. PATIENT RECOVERED.

  Patient problems: Septic Shock

  MAUDE report 11699584 ↗
• InjuryApr 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE A VENA SEAL CLOSURE SYSTEM WAS USED TO TREAT A LESION LOCATED IN THE GREAT SAPHENOUS VEIN 1. APPROXIMATELY TWENTY SEVEN DAYS POST PROCEDURE, PATIENT SUFFERED FROM A PULMONARY EMBOLISM SECONDARY TO DEEP VEIN THROMBOSIS. THE EVENT WAS TREATED WITH MEDICATION. PATIENT RECOVERED.

  Patient problems: Pulmonary Embolism; Thrombosis/Thrombus

  MAUDE report 11698937 ↗
• InjuryApr 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE A VENA SEAL CLOSURE SYSTEM WAS USED. APPROXIMATELY SIX DAYS POST PROCEDURE, PATIENT SUFFERED OF QUADRIPLEGIA SECONDARY TO CERVICAL EPIDURAL ABSCESS WITH CORD HEMATOMA. THE EVENT WAS TREATED WITH LAMINECTOMY OF CERVICAL SPINE AND CHANGE OF MEDICATION. PATIENT HAS NOT RECOVERED.

  Patient problems: Abscess; Hematoma; Quadriplegia

  MAUDE report 11698929 ↗
• InjuryApr 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PHYSICIAN USED VENASEAL FOR TREATMENT OF THE PATIENT¿S SHORT SAPHENOUS VEIN (SSV). PROCEDURE WAS COMPLETED AS PER IFU. A GUIDEWIRE WAS USED FOR INSERTION OF THE CATHETER. THE PHYSICIAN CONFIRMED CATHETER TIP 5CM FROM DEEP SYSTEM VIA ULTRASOUND BEFORE DISPENSING GLUE. THE VEIN IS REPORTED TO HAVE CLOSED. UPON FOLLOW UP A GLUE EXTENSION WAS NOTICED IN THE POPLITEAL VEIN EXTENDING 0.33MM. THE PATIENT WAS PUT ON XARELTO FOR 2 WEEKS THEN RESCANNED. THE GLUE EXTENSION WAS STILL PRESENT AND WAS THE SAME SIZE AT 0.33MM, PATIENT EXPERIENCED SIDE EFFECTS OF XARELTO AND IS NOW TAKING ASPIRIN. ADDITIONAL ULTRASOUND SCANS WERE REQUIRED TO CHECK GLUE EXTENSION INTO POPLITEAL VEIN AND PATIENT WAS PRESCRIBED ANTIPLATELET MEDICATION. NO FURTHER INJURY REPORTED.

  Patient problems: Thrombosis/Thrombus; Unspecified Tissue Injury

  MAUDE report 11654965 ↗
• InjuryApr 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT VENASEAL TREATMENT OF THE RIGHT GREAT SAPHENOUS VEIN (GSV). THE PROCEDURE WAS COMPLETED AS PER IFU WITHOUT ISSUE. STERILE TECHNIQUES WERE FOLLOWED DURING THE PROCEDURE. THE VEIN IS REPORTED TO HAVE CLOSED, WITH NO ISSUES NOTED. ONE-MONTH POST PROCEDURE IT IS REPORTED THAT THE PATIENT WAS ADMITTED TO HOSPITAL WITH A FEVER OF 104 DEGREES AND A POSITIVE BLOOD CULTURE FOR STAPH. IT IS UNKNOWN IF THIS IS RELATED TO THE IMPLANT. THE PATIENT HAD BEEN UNDER THE CARE OF AN INFECTIOUS DISEASE SPECIALISTS AND WAS ON IV AND ORAL ANTIBIOTICS. THE INFECTION RESPONDED TO ANTIBIOTICS OVER A TWO WEEK PERIOD. THE PATIENT IS NOW ON AN ORAL ANTIBIOTIC. THE INFECTION HAS RESOLVED. THE PATIENT IS STILL IN THE REHAB FACILITY WORKING ON AMBULATION AND LYMPHEDEMA. THESE ARE ISSUES THAT THE PATIENT WAS DEALING WITH LONG BEFORE THE ABLATION PROCEDURES. AS FAR AS THE CELLULITIS GOES, THE PATIENT HAS BEEN TAKEN OFF IV ANTIBIOTICS AND CONTINUE ON AN ORAL ANTIBIOTIC. CELLULITIS IS NO LONGER EVIDENT ON PHYSICAL EXAMINATION. THE PATIENT HAS AN APPOINTMENT WITH THE INFECTIOUS DISEASE SPECIALIST IN EARLY MAY AND IT IS BELIEVED THE PATIENT WILL BE ON ORAL ANTIBIOTICS UNTIL THEN. NO FURTHER INJURY RE

  Patient problems: Unspecified Infection

  MAUDE report 11654558 ↗
• InjuryMar 19, 2021Defective Device; Defective Device

  PHYSICIAN INTENDED TO USE A VENASEAL KIT DURING TREATMENT OF THE PATIENT¿S GREAT SAPHENOUS VEIN (GSV). IFU WAS FOLLOWED. A GUIDEWIRE WAS USED FOR INSERTION OF THE CATHETER. IT IS REPORTED THE GLUE GUN WOULD NOT PROPERLY ENGAGE. A SECOND KIT WAS OPENED TO COMPLETE THE PROCEDURE. 1 SEGMENT WAS TREATED, AND THE VEIN IS REPORTED TO HAVE CLOSED. IT WAS REPORTED THAT THERE WERE GAPS IN TREATMENT ALONG THE VEIN. THIS LED TO THE PATIENT DEVELOPING THROMBOPHLEBITIS. THE PATIENT WAS PRESCRIBED NSAIDS AND INSTRUCTED TO APPLY WARM COMPRESS TO THE AREA.

  Patient problems: Thrombosis/Thrombus; Vasculitis

  MAUDE report 11524274 ↗
• InjuryMar 5, 2021Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  THE PHYSICIAN USED A VENASEAL KIT DURING TREATMENT OF THE PATIENT¿S GREAT SAPHENOUS VEIN, 50CM WAS TREATED (5CM FROM SFJ DOWN TO DISTAL CALF). THE IFU WAS FOLLOWED. LOCAL ANESTHESIA AND TRANSDUCER COMPRESSION WERE USED. THE PHYSICIAN TREATED THE VEIN AS PER THE IFU AND THE PROCEDURE WAS COMPLETED WITH NO ISSUES. THE VEIN IS REPORTED TO HAVE CLOSED. THE PATIENT WAS FINE AT THE POST OP FOLLOW UP SCAN, THE VEIN WAS CLOSED AND NO DEEP VEIN THROMBOSIS. WHEN THE PATIENT CAME FOR ANOTHER FOLLOW UP APPOINTMENT IT WAS REPORTED THAT A RED ITCHY RASH WITH SLIGHT SWELLING AND SOME TENDERNESS HAD DEVELOPED ALONG THE COURSE OF THE TREATED VEIN. THE PATIENT DEVELOPED A POSSIBLE HYPER SENSITIVITY REACTION TO CYANOACRYLATE. THE PHYSICIAN PRESCRIBED A MEDROL DOSE PACK. THE PATIENT RETURNED FOR A FOLLOW UP AND EVERYTHING HAD RESOLVED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 11420451 ↗
• InjuryFeb 17, 2021Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  PHYSICIAN USED A VENASEAL KIT DURING TREATMENT OF THE PATIENT¿S SHORT SAPHENOUS VEIN (SSV). IFU WAS FOLLOWED. IT IS REPORTED THE PATIENT EXPERIENCED ANAPHYLAXIS REACTION POST VENASEAL PROCEDURE. THE PATIENT WAS TAKEN VIA AMBULANCE FROM THE CLINIC THE PROCEDURE WAS PERFORMED AT TO HOSPITAL. ACCORDING TO PHYSICIAN WHO CARRIED OUT THE VENASEAL PROCEDURE, THE PATIENT IS DOING WELL. PATIENT SUFFERED DIFFICULTY BREATHING, SWOLLEN LIPS AND DIZZINESS. AT THE VEIN CENTER, THE PATIENT WAS PROVIDED SUPPLEMENTAL OXYGEN, AND GIVEN BENADRYL AND EPINEPHRINE. PATIENT HAS NO KNOWN ALLERGIES HOWEVER, THE PATIENT HAD TWO PREVIOUS TREATMENTS WITH VENASEAL AND NO REACTIONS IN EITHER SCENARIO. NO FURTHER INJURY REPORTED.

  Patient problems: Dizziness; Local Reaction

  MAUDE report 11336381 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P140018. One submission often covers many models, so check the product and lot details in each record.

• Z-1599-2015 · Apr 28, 2015 · Terminated
  VenaSeal, Sapheon Closure System, Model # SP-101, VS-301 and VS-402. For vascular use.