AngioVac 25194Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI H965251940), received between Sep 23, 2020 and Dec 11, 2024 — classified as 7 deaths, 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Air/Gas in Device” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryDec 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ANGIODYNAMICS TERRITORY MANAGER REPORTED A PATIENT ADVERSE EVENT THAT WAS DISCOVERED IMMEDIATELY FOLLOWING A SUCCESSFUL PROCEDURE WITH AN ANGIOVAC C180 WITH OBTURATOR PG. A POST PROCEDURE ECHOCARDIOGRAM WAS PERFORMED AND SHOWED A PERICARDIAL EFFUSION. THIS REQUIRED THE PHYSICIAN TO OPEN THE PATIENT FOR REPAIR AND TO PLACE A DRAIN. THE PHYSICIAN BELIEVES THE PLEURAL EFFUSION MAY BE THE RESULT OF A WIRE PERFORATION THAT OCCURRED DURING INSERTION OF THE WIRE BECAUSE THE HOLE IN THE PATIENT WAS 'NOT LARGE;' HOWEVER, THIS IS NOT CONFIRMED. CURRENTLY, THE PATIENT IS DOING WELL. THE PHYSICIAN HAS BEEN USING ANGIOVAC DEVICES FOR 5 YEARS AND IS A VERY EXPERIENCED USER. THE PROCEDURE WAS PERFORMED IN ACCORDANCE WITH THE DIRECTIONS FOR USE (DFU).

  Patient problems: Pleural Effusion

  MAUDE report 20906758 ↗
• DeathOct 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ANGIODYNAMICS CLINICAL SPECIALIST REPORTED THE FOLLOWING PATIENT ISSUE DURING AN ALPHAVAC PROCEDURE: "A 59-YEAR-OLD FEMALE WITH A HISTORY OF CANCER AND CONCERN FOR METASTASIS PRESENTED WITH MATERIAL IN THE IVC EXTENDING INTO THE RIGHT ATRIUM. IN THE PRE-CASE PLANNING DISCUSSION, THE PHYSICIAN STATED THAT THERE WOULD BE TWO PARTS OF THE PROCEDURE. IN PART ONE, THE CT SURGEON WOULD USE ANGIOVAC TO ASPIRATE MATERIAL IN THE RIGHT ATRIUM. HE PLANNED TO ACCESS THE RIGHT INTERNAL JUGULAR VEIN FOR ASPIRATION WITH ANGIOVAC AND THE LEFT INTERNAL JUGULAR VEIN FOR THE BLOOD RETURN CANNULA. IN PART TWO, THE VASCULAR SURGEON WOULD USE ALPHAVAC TO ASPIRATE MATERIAL IN THE IVC. HE PLANNED TO ACCESS THE RIGHT FEMORAL VEIN FOR ASPIRATION. THE PATIENT WAS BROUGHT TO THE OR FOR THE PROCEDURE. PREPROCEDURAL VITALS WERE STABLE. THE PATIENT WAS PREPPED AND DRAPED IN A STERILE FASHION. TEE PROBE WAS INTRODUCED AND CONFIRMED MOVEABLE MATERIAL IN THE RIGHT ATRIUM EXTENDING DOWN INTO IVC. THE ANGIOVAC CIRCUIT WAS PREPPED AND PRIMED. THE CT SURGEON USED ULTRASOUND GUIDANCE TO GAIN ACCESS INTO THE RIGHT AND LEFT INTERNAL JUGULAR VEINS AND PLACED A SMALL BORE SHEATH IN EACH VEIN. THE PATIENT WAS GIVEN HEPARI

  Patient problems: Perforation of Vessels

  MAUDE report 18041484 ↗
• DeathJul 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ANGIODYNAMICS SENIOR TERRITORY MANAGER REPORTED A PATIENT ADVERSE OUTCOME, FOLLOWING AN ANGIOVAC PROCEDURE. THE ANGIOVAC C180 WAS CHOSEN TO REMOVE TRICUSPID VALVE VEGETATION IN A CHRONICALLY ILL PATIENT. THERE WAS NO DEVICE MALFUNCTION AND THE PROCEDURE WAS PERFORMED IN ACCORDANCE WITH THE IFU (INSTRUCTIONS FOR USE.) THE ANGIOVAC WAS REPORTED TO HAVE BEEN VERY SUCCESSFUL IN REMOVING VEGETATION AND PERFORMED AS INTENDED. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE; HOWEVER, 6 HOURS FOLLOWING COMPLETION, THE PATIENT EXPERIENCED A PULMONARY BLEED/ HEMORRHAGE. THE PATIENT RECOVERED UNTIL A SECOND HEMORRHAGE OCCURRED APPROXIMATELY 24 HOURS LATER, RESULTING IN THE PATIENT ULTIMATELY EXPIRING. PATIENT WAS REPORTED TO BE AN IV DRUG USER WITH SEVERAL COMORBIDITIES INCLUDING: INFECTIVE ENDOCARDITIS OF TRICUSPID VALVE CAUSING STENOSIS OF PROSTHETIC VALVE, HIV, HEPATITIS C, MRSA AND MULTIPLE LUNG ABSCESSES AS A RESULT OF "THROWING" A BLOOD CLOT. THE PHYSICIAN BELIEVES THAT THE ADVERSE OUTCOME IS A RESULT OF THE PATIENT'S MULTIPLE COMORBIDITIES AND IS UNRELATED TO THE ANGIODYNAMICS DEVICE.

  Patient problems: Exsanguination

  MAUDE report 17364255 ↗
• DeathJun 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CLINICAL SPECIALIST REPORTED AN THAT DURING A PROCEDURE AND POST USE OF AN ANGIOVAC C180 WITH OBTURATOR, THE PATIENT EXPIRED. THERE WAS NO DEVICE MALFUNCTION AS THE ANGIOVAC DEVICE PORTION OF THE PROCEDURE HAD BEEN SUCCESSFUL. 76/F PRESENTED WITH SHORTNESS OF BREATH FOR SEVERAL MONTHS. FOUND TO HAVE CLOT COMPLETELY OCCLUDING THE RIGHT PULMONARY ARTERY AND A LARGE CLOT IN TRANSIT IN THE RIGHT ATRIUM. DR. (B)(6) REACHED OUT TO US FOR REMOVAL OF RIGHT ATRIAL CLOT IN TRANSIT AND POSSIBLE REMOVAL OF PULMONARY EMBOLISM. STATED HE WANTED TO USE ANGIOVAC FOR PE DUE TO PATIENT'S POOR RENAL FUNCTION AND INABILITY TO TOLERATE CONTRAST. I INFORMED DR. (B)(6) THAT PE PORTION OF CASE WOULD BE AN OFF-LABEL USE OF THE DEVICE AND HE WISHED TO PROCEED ANYWAY. PATIENT WAS TAKEN TO CATH LAB AT (B)(6) HOSPITAL ON (B)(6)2023. PLAN WAS FOR LEFT FORMAL VEIN REINFUSION USING 17F CANNULA, RIGHT IJ ACCESS WITH 26F SHEATH FOR ASPIRATION WITH THE ANGIOVAC C180 CANNULA. THE RIGHT FEMORAL VEIN AND ARTERY WERE ACCESSED FOR ECMO CANNULATION, WHICH DR. (B)(6) BELIEVED TO BE POSSIBLY NEEDED DURING THE PROCEDURE DUE TO THE PATIENT'S POOR CONDITION. ALL ACCESS WAS GAINED WITHOUT ISSUE AFTER ACT CONFIRMED >300. PATIE

  Patient problems: Aneurysm; Cardiac Arrest

  MAUDE report 17071834 ↗
• DeathMay 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ANGIODYNAMICS' CLINICAL SPECIALIST REPORTED AN ADVERSE EVENT THAT OCCURRED DURING A PROCEDURE USING AN ANGIOVAC C180 WITH OBTURATOR. 44 YO FEMALE WITH A HISTORY OF SLEEVE GASTRECTOMY, ESOPHAGEAL ULCERS, UPPER GASTROINTESTINAL BLEED, PRIOR COLON PERFORATION (B)(6) 2023) S/P COLECTOMY, AND RECENT ADMISSION (B)(6) 2023) FOR PE WITH SEPTIC EMBOLI AND AKI. DURING HER PREVIOUS ADMISSION (B)(6) 2023) PATIENT WAS FOUND TO HAVE RIGHT-SIDED ENDOCARDITIS WITH LARGE VEGETATION IN THE CORONARY SINUS WHICH WAS MEDICALLY MANAGED. IN THE CURRENT ADMISSION, THE PATIENT PRESENTED TO THE HOSPITAL WITH ABDOMINAL PAIN, NAUSEA, AND VOMITING. SHE WAS FOUND TO BE TACHYCARDIC AND HYPOTENSIVE AND ADMITTED TO THE MICU FOR HYPOTENSION AND ANEMIA WITH A CONCERN FOR UPPER GASTROINTESTINAL BLEEDING. THE PATIENT RECEIVED AN EGD AND CTA WITH NO BLEEDING SOURCE IDENTIFIED. THE PATIENT RECEIVED A TTE WHICH CONFIRMED THE PRESENCE OF RIGHT ATRIAL MATERIAL. INTERVENTIONAL CARDIOLOGY WAS CONSULTED FOR THROMBECTOMY PROCEDURE. THE PATIENT WAS BROUGHT TO THE HYBRID OR FOR ANGIOVAC PROCEDURE. THE PATIENT CAME FROM THE MICU AND WAS INTUBATED AND SEDATED. THE PATIENT WAS PREPPED AND DRAPED IN A STERILE FASHION. A TEE PROBE

  Patient problems: Cardiac Arrest; Decreased Respiratory Rate; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16933209 ↗
• DeathMay 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ANGIODYNAMICS' CLINICAL SPECIALIST REPORTED A PATIENT DEATH DURING A PROCEDURE IN WHICH AN ANGIOVAC C180 WITH OBTURATOR AND CIRCUIT WITH BUBBLE TRAP WERE BEING USED. AS REPORTED: MALE PATIENT, BROUGHT INTO OR6 FOR AN ANGIOVAC LEAD MASS REMOVAL, FOLLOWED BY A LASER LEAD EXTRACTION. ANESTHESIA SET UP THEIR LINES AND ACCESSES (IJ). DR. HIBBERT AND FELLOW, AS WELL AS EP PHYSICIAN SCRUBBED IN TO GAIN THEIR FEMORAL ACCESSES. ANESTHESIA ASKED FOR PADS, DUE TO ARRYTHMIA AND HYPOTENSION OF PATIENT, THEY WERE NOT USED. 26F GORE DRY-SEAL SHEATH WAS INSTALLED, FOLLOWED BY THE REINFUSION CANNULA. PERFUSION PRIMED THE ANGIOVAC CIRCUIT. THE ANGIOVAC CANNULA WAS THEN ATTACHED TO THE CIRCUIT, AND THE REINFUSION CANNULA WAS ALSO ATTACHED TO THE CIRCUIT. THE CANNULA WAS INSERTED INTO THE PATIENT, THE INTRODUCER AND GUIDEWIRE WERE REMOVED, THE FUNNEL WAS EXTENDED, AND THE CENTRIFUGAL PUMP WAS TURNED ON SLOWLY. ONCE HEMODYNAMICS WERE CONFIRMED STABLE, AND THE CIRCUIT NO LONGER CONTAINED ONLY SALINE, THE PHYSICIANS PROCEEDED TO ASK PERFUSION TO INCREASE THE FLOW OF THE CIRCUIT, AND ADVANCE THE FUNNEL TO THE MASS. THE MASS WAS VISIBLY BEING REDUCED. PERFUSION AND MYSELF (CLINICAL SPECIALIST) NOTED THE

  Patient problems: Cardiac Arrest

  MAUDE report 16897001 ↗
• InjuryApr 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING AN ANGIOVAC C180 WITH OBTURATOR. A 77-YEAR-OLD FEMALE PRESENTS WITH MYXOMA IN THE RIGHT ATRIUM. THE PATIENT WAS BROUGHT INTO THE CATH LAB FOR ANGIOVAC PROCEDURE. THE PATIENT WAS PREPPED AND DRAPED IN A STERILE FASHION. TEE PROBE WAS INTRODUCED AND CONFIRMED MYXOMA ON THE FREE WALL OF THE RIGHT ATRIUM. PRE-PROCEDURE VITALS BP 114/59 (78), HR 50 NSR, SPO2 99%. THE ANGIOVAC CIRCUIT WAS PREPPED AND PRIMED. A MICROPUNCTURE KIT AND ULTRASOUND GUIDANCE WERE USED TO PLACE ONE 6F SHEATH IN THE RIGHT FEMORAL VEIN AND TWO 6F SHEATHS IN THE LEFT FEMORAL VEIN. THE PATIENT WAS GIVEN HEPARIN TO ACHIEVE AN ACT OF 300. THE RIGHT FEMORAL VEIN SHEATH WAS UPSIZED TO A 26F GORE DRYSEAL AND ONE OF THE LEFT FEMORAL VEIN SHEATHS WAS UPSIZED TO A 17F ARTERIAL RETURN CANNULA. A BOSTON SCIENTIFIC "CAPTIVATOR" SNARE WAS PLACED THROUGH THE 6F SHEATH IN THE LEFT FEMORAL VEIN. THE SNARE WAS PLACED AROUND THE 26F GORE DRYSEAL. THE ANGIOVAC CANNULA WITH OBTURATOR WAS PLACED IN THE BODY THROUGH THE 26F GORE DRYSEAL OVER A STIFF WIRE. WIRE AND DILATOR WERE REMOVED FROM THE ANGIOVAC CANNULA. THE ANGIOVAC CANNULA WAS ADVANCED FORWARD TO EXPOSE TH

  Patient problems: Perforation of Vessels

  MAUDE report 16755040 ↗
• InjuryJan 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CLINICAL SPECIALIST REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING AN ANGIOVAC C180 DEVICE. THE PATIENT WAS BROUGHT INTO ROOM AND TEE PERFORMED. TEE IDENTIFIED THE MATERIAL ON THE TRICUSPID VALVE. PRE-CASE, THE PATIENT SATS WERE IN 70'S, HYPOTENSIVE, AND SUFFERING FROM CARDIOGENIC SHOCK. THE PATIENT WAS PREPPED IN STERILE FASHION. ACCESS ATTEMPTED IN RIJ WITH NO SUCCESS, SO THE PHYSICIAN DECIDED TO GO RIGHT FEMORAL VEIN FOR ASPIRATION AND LEFT FEMORAL VEIN FOR RETURN. UPON GAINING ACCESS, THE PHYSICIAN WAS UNABLE TO GET 26FR GORE DRYSEAL TO FIT THE RIGHT FEMORAL VEIN SO HE DECIDED TO PLACE THE RETURN THERE AND THE 26FR GORE DRY SEAL IN THE LEFT FEMORAL VEIN. HEPARIN WAS ADMINISTERED, AND ACT WAS ABOVE 300. ANGIOVAC CONNECTIONS WERE ESTABLISHED AND EVERYTHING WAS CONFIRMED TO BE AIR FREE. ANGIOVAC WAS INSERTED IN THE PATIENT AND POSITIONED ABOVE TRICUSPID VALVE MATERIAL. THE PUMP WAS TURNED ON AND ANGIOVAC BEGAN TO DEBULK THE MATERIAL. AS THEY WENT UP ON FLOWS, MATERIAL WAS STILL CONTINUING TO BE DEBULKED AND SUDDENLY PHYSICIAN REALIZED O2 SATS DROPPED AND COULDN'T FEEL PULSE. THE ANGIOVAC WAS IMMEDIATELY PULLED INTO IVC, EPINEPHRINE GIVEN, AND CPR BEGAN. THE PATIENT APPEARE

  Patient problems: Cardiac Arrest; Decreased Respiratory Rate; Pulmonary Embolism

  MAUDE report 13257472 ↗
• InjuryFeb 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ANGIODYNAMICS CLINICAL SPECIALIST REPORTED THE FOLLOWING EVENT, DURING A PROCEDURE, WITH AN ANGIOVAC CANNULA: "(B)(6) YO FEMALE PATIENT. POST CABG IN DECEMBER. PATIENT HAD EXISTING PULMONARY EMBOLUS AND CHRONIC RA THROMBUS. PATIENT ALSO HAD HEPARIN INDUCED THROMBOCYTOPENIA AND WAS ON ARGATROBAN. DURING ANGIOVAC PROCEDURE IN THE RIGHT ATRIUM, UIM OCCLUDED THE FUNNEL TIP. THE TEE SHOWED THAT THE MATERIAL WAS ON THE FUNNEL AND THAT THE RIGHT ATRIUM WAS CLEAR. THE PHYSICIANS REMOVED THE ANGIOVAC AND THE GORE DRY SEAL WHILE ON PUMP/SUCTION. DURING THIS PROCESS, THE MATERIAL DISLODGED AND COULD BE SEEN TUMBLING IN THE RIGHT ATRIUM, THEN QUICKLY EMBOLIZED TO THE LUNGS. ANGIOVAC WAS REMOVED AND THE INARI FLOWTRIEVER WAS INSERTED TO TRY AND CHASE THE PULMONARY EMBOLUS. THEY WERE UNSUCCESSFUL AND DURING THIS TIME THE PATIENT'S OXYGEN SATURATION BEGAN TO DROP AND THEY CODED THE PATIENT AND BEGAN COMPRESSIONS. THEY WERE DISCUSSING AND PREPARING TO GO INTO AN OPEN PROCEDURE ON THE PATIENT TO REMOVE THE EMBOLUS AS WE STEPPED OUT OF THE ROOM. THE FOLLOWING DAY, THE SALES REP RECEIVED INFORMATION FROM ONE OF THE PERFORMING PHYSICIANS THAT THE PATIENT WAS STABLE, ON ECMO, AND AWAKE/ALERT." THE D

  Patient problems: Pulmonary Embolism

  MAUDE report 11387199 ↗
• DeathJan 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ANGIODYNAMICS SENIOR TM REPORTED AN EVENT DURING A CASE WHERE AN ANGIOVAC DEVICE WAS USED TO ASSIST IN TRICUSPID VEGETATION REMOVAL WITH LEAD EXTRACTION. THE TM WAS ATTENDING THE PROCEDURE. PER HER EVENT DESCRIPTION: TODAY WE DID OUR FIRST ANGIOVAC CASE USING THE NEW C180 CANNULA. THE PATIENT WAS A MALE WHO WAS PACEMAKER DEPENDENT, HAD DIABETES, FOOT ULCERS, HAD KIDNEY FAILURE REQUIRING DIALYSIS, AND A VERY POOR LV EJECTION FRACTION OF ONLY 12%. THE PATIENT HAD FOUR LEADS THAT NEEDED TO BE LASER EXTRACTED AND VEGETATION WAS NOTED ON TWO AREAS OF THE TRICUSPID VALVE. THE SURGEON'S PLAN WAS TO USE ANGIOVAC TO REMOVE THE VEGETATION FROM THE TRICUSPID VALVE (WHICH IT DID VERY WELL) AND THEN KEEP THE ANGIOVAC IN THE RA WHILE THE LASER LEAD EXTRACTION WAS OCCURRING TO SUCTION UP ANY DEBRIS THAT ESCAPED FROM THE LEADS WHILE BEING EXTRACTED. DURING THE LEAD EXTRACTION, THE PATIENT'S PRESSURE AND HEART RATE STARTED TO DECLINE. THERE WAS BLOOD LOSS ASSOCIATED WITH THE LEAD EXTRACTION AND THE PATIENT WAS QUITE ILL AS NOTED ABOVE TO START WITH. DESPITE EFFORTS TO INCREASE BOTH THE PATIENT'S PRESSURE AND HEART RATE, HE SUBSEQUENTLY SUCCUMBED DURING THE PROCEDURE. THIS IS NOT A PRODUCT COMPLA

  Patient problems: Exsanguination

  MAUDE report 11182949 ↗
• DeathJan 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ANGIODYNAMICS REPRESENTATIVE REPORTED THE FOLLOWING EVENT IN WHICH AN ANGIOVAC WAS BEING USED. PER THE REPRESENTATIVE, "CALLED TO HOSPITAL FOR A CLOT IN TRANSIT CASE. PATIENT BEGAN TO DECOMPENSATE WHEN THEY LAID HER FLAT AND INTUBATED HER (70S) WE PROCEEDED WITH ANGIOVAC (FEM/FEM) AND WERE ON PUMP FOR 4 MINUTES AND SUCCESSFULLY REMOVED THE LARGE, 7 INCH PIECE OF CLOT. WE RETURNED THE BLOOD TO THE PATIENT AND ENDED THE ANGIOVAC PORTION. THE DOCTOR THEN USED ANOTHER MEDICAL DEVICE (INARI FLOWTRIEVER) TO GO AFTER THE PE AND THE PATIENT'S SATS DROPPED MORE (50S) AND THEY BEGAN CHEST COMPRESSIONS. THE PATIENT DID NOT IMPROVE SO THE SURGEON DECIDED TO OPEN THE CHEST AND DO AN OPEN, PULMONARY EMBOLECTOMY. I STAYED FOR A COUPLE HOURS. THEY WERE STILL WORKING WHEN I LEFT." ADDITIONAL INFORMATION PROVIDED REPORTED THE PATIENT EXPIRED. THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Exsanguination

  MAUDE report 11182940 ↗
• MalfunctionDec 17, 2020Loss of or Failure to Bond; Detachment of Device or Device Component; Loss of or Failure to Bond; Detachment of Device or Device Component

  AN ANGIODYNAMICS TERRITORY MANAGER REPORTED AN ISSUE WITH AN ANGIOVAC C180 WITH OBTURATOR. AFTER THE INITIAL TYPICAL SETUP AND PREP OF THE ANGIOVAC CIRCUIT, THE BRAND NEW CANNULA WAS OPENED ON THE TABLE IN STERILE FASHION. UPON OPENING THE CANNULA IT WAS NOTED THAT THE STOPCOCK ON THE OUTER SLEEVE WAS NOT ATTACHED AT ALL, IT APPEARED AS IF IT WAS NOT CONSTRUCTED PROPERLY DURING MANUFACTURING PROCESS. SINCE THIS WAS THE FIRST TIME I (B)(6) EXPERIENCED THIS, I TOLD THE PHYSICIAN TO GIVE ME A MINUTE SO THAT I COULD ASK THE SENIORS ON THE CLINICAL TEAM IF THEY'VE EXPERIENCED THIS PHENOMENON. I CALLED (B)(6), AND HE SUGGESTED THAT HE'S SEEN PHYSICIANS IN THE PAST PLACE A TEGADERM OVER THE PORT TO FIX THE ISSUE. I MENTIONED THAT TO THE PHYSICIAN AND HE PROCEEDED TO USE PETROLEUM JELLY / "BACITRACIN WAS HIS EXACT WORDS" ON THE PORT DISREGARDING MY ADVICE AT THE TIME. PHYSICIAN THEN INSERTED THE ANGIOVAC CAME ON PUMP AND SHORTLY AFTER WE EXPERIENCED MICRO BUBBLES IN THE CIRCUIT AND SAW MICRO BUBBLES IN THE RIGHT ATRIUM. WE THEN CAME OFF PUMP, CLEARED THE CIRCUIT OF BUBBLES AND THEN HE DECIDED TO PLACE A TEGADERM ON THE AFFECTED AREA. THE PATIENT TOLERATED THE MICRO BUBBLES WITHOUT ANY HEMO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11028169 ↗
• InjuryNov 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS MEDWATCH IS NOT TO REPORT A PRODUCT MALFUNCTION, BUT TO REPORT AND ADVERSE PATIENT EVENT THAT OCCURED WHEN AN ANGIODYNAMICS PRODUCT WAS IN USE. AN ANGIODYNAMICS CLINICAL SPECIALIST REPORTED AN EMBOLIC EVENT OCCURRED WHILE SUPPORTING A CASE VIA (B)(6). THE FOLLOWING WAS REPORTED: "AGE OF PATIENT NOT CONFIRMED. HISTORY OF BREAST CANCER. CAME IN FOR CHEMO AND RESTLESS LEGS AND DVT FOUND. ADMITTED TO THE HOSPITAL AND WAS SCREENED FOR PULMONARY EMBOLISMS. FOUND TUMBLING RIGHT ATRIAL MATERIAL. ANGIOVAC PROCEDURE SCHEDULED FOR FOLLOWING DAY. TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) PROBE WAS IN PLACE. THE MATERIAL WAS STILL PRESENT UPON INVESTIGATION. MATERIAL APPEARED TO BE ATTACHED TO THE SUBVALULAR PORTION OF THE TRICUSPID VALVE AND SITTING IN THE RIGHT VENTRICLE (RV). PFO PRESENT PER MD AND THE POTENTIAL OF MATERIAL EMBOLIZING ACROSS IT WAS KNOWN BY ALL AND PROCEDURE ROOM IF PROCEDURE CONTINUED. THE RIGHT INTERNAL JUGULAR (RIJ) VEIN WAS ACCESSED AND A 6FR SHEATH WAS ESTABLISHED WHILE PHYSICIAN WORKED ON RIGHT FEMORAL VEIN (RFV) ACCESS. RIGHT FEMORAL VEIN (RFV) ACCESS WAS OBTAINED AND THEN UPSIZED TO ARTERIAL REINFUSION CANNULA. RIJ WAS UPSIZED TO A 26FR GORE DRY SEAL (GDS) SHEATH. HE

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 10828903 ↗
• InjuryNov 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ANGIODYNAMICS CLINICAL SPECIALIST REPORTED AN ISSUE DURING AN ANGIOVAC PROCEDURE, WHILE USING AN ANGIOVAC C180 WITH OBTURATOR. THE PATIENT WAS BEING TREATED FOR CHRONIC THROMBUS ON THEIR ARTERIAL LEADS. EMBOLIZATION OCCURRED AFTER THE THROMBUS MATERIAL WAS CAPTURED BY THE ANGIOVAC AND WAS TOO LARGE IN SIZE TO FIT INTO THE CANNULA. THE MATERIAL WAS WEDGED IN THE 26FR GORE WIRE AND EMBOLIZED. THE PHYSICIAN ACCIDENTLY PUSHED THE MATERIAL OUT OF THE GORE DRY SEAL WHEN ATTEMPTING TO USE WALL SECTION AND WEDGE THE MATERIAL IN MORE. ANGIOVAC WAS PULLED INTO THE GDS AND OUT OF THE BODY. THERE WAS NO MATERIAL FOUND IN THE FILTER OR IN THE ANGIOVAC CANNULA OR CIRCUIT. THE GDS DID NOT BLEED BACK WHICH GAVE THE INDICATION THAT THE MATERIAL WAS POTENTIALLY LODGED IN THE GDS. BEFORE REMOVING THE GDS, THE PHYSICIAN WANTED TO REASSURE THAT THE MATERIAL WASN'T JUST SITTING AT THE DISTAL TIP, AND DECIDED TO USE WALL SUCTION TO HELP PULL THE MATERIAL FURTHER INTO THE GDS, PRIOR TO REMOVAL. DURING THAT PROCESS, THE MATERIAL WAS INADVERTENTLY DISLODGED FROM GDS. IT WAS IDENTIFIED ON TEE IN THE RA AND THEN MADE ITS WAY TO THE LEFT PULMONARY ARTERY. THE PATIENTS HEMODYNAMICS DID NOT CHANGE AND APPEARE

  Patient problems: Pulmonary Embolism

  MAUDE report 10777224 ↗
• MalfunctionNov 3, 2020Fluid/Blood Leak; Air/Gas in Device; Fluid/Blood Leak; Air/Gas in Device

  AN ANGIODYNAMICS SENIOR CLINICAL SCIENCE LIAISON REPORTED AN ISSUE WITH A ANGIOVAC C180 WITH OBTURATOR. WHEN THE C180 CANNULA WAS REMOVED FROM THE PACKAGE AND THE SIDE PORT WAS FLUSHED, IT WAS NOTICED THAT THERE WAS A LEAK, WHERE THE SIDE PORT ATTACHED TO THE OVER SHEATH. THIS LEAK WAS SIGNIFICANT ENOUGH, THAT WHEN THE SIDE PORT WAS FLUSHED, A JET OF SALINE, EXITED THE ATTACHMENT. DUE TO THE FACT THAT THIS WAS A BORROWED CANNULA AND THERE WAS NO REPLACEMENT OPTION, THE LIAISON SUGGESTED USING DERMABOND TO GLUE/SEAL THE LEAK. AFTER WAITING APPROXIMATELY 5 MINUTES, THE SIDE PORT WAS FLUSHED AGAIN, AND THE LEAK APPEARED TO BE FIXED. THE CANNULA WAS INSERTED, FLOW WAS ESTABLISHED, AND THE MATERIAL WAS ENGAGED. AFTER APPROXIMATELY 10 MINUTES OF BEING ON PUMP, THE LIASON NOTICED THAT THE CIRCUIT (BLUE SIDE) LEADING TO THE BUBBLE TRAP FILTER WAS FULL OF AIR. THE PERFUSIONIST CLAMPED OFF THE LINE AND AFTER SEARCHING FOR THE CAUSE OF THE AIR, IT WAS NOTICED THAT THE SIDE PORT HAD BROKEN OFF. AIR WAS BEING SUCKED INTO THE CIRCUIT THROUGH THE HOLE, WHERE THE SIDE PORT HAD BEEN ATTACHED. DERMABOND GLUE WAS, AGAIN, PLACED OVER THE HOLE IN THE OVER SHEATH. THE CIRCUIT WAS RE-PRIMED AND AFTER 10

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10777214 ↗
• InjurySep 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ANGIODYNAMICS CLINICAL SPECIALIST REPORTED AN ISSUE WITH AN ANGIOVAC C180, WITH OBTURATOR, DURING A PROCEDURE. THE PATIENT HAS A HISTORY OF ACTIVE IVDU, INFECTIVE TRICUSPID VALVE ENDOCARDITIS WITH LARGE VEGETATION ON THE POSTERIOR LEAFLET. 63.5KG. ETCO 29. ARTERIAL B/P 113/70 MAP 84. PATIENT WAS BROUGHT INTO THE CATH LAB AND PREPPED IN A STERILE FASHION. ANESTHESIOLOGISTS HAD DIFFICULTY ACCESSING FOR A CENTRAL LINE AND ASKED THE INTERVENTIONAL CARDIOLOGIST TO OBTAIN ACCESS FOR THEM. AFTER SUCCESSFULLY INTUBATING THE PATIENT, A TEE PROBE WAS INTRODUCED CONFIRMING PRESENTS OF LARGE TV VEGETATIONS AND LARGE PFO. REMAINING SURGICAL EQUIPMENT WAS OPENED AND ANGIOVAC CIRCUIT WAS PRIMED USING NORMALSOL. THE RIGHT INTERNAL JUGULAR WAS ACCESSED UNDER ULTRASOUND WITH A 6FR SHEATH. ACCESS WAS OBTAINED BY ULTRASOUND GUIDANCE IN THE RIGHT AND LEFT FEMORAL VEINS USING 6FR SHEATHS. THE RIGHT FEMORAL VEIN WAS ATTACHED TO EXTENSION TUBING FOR ANESTHESIOLOGISTS USE. THE RIGHT AND LEFT FEMORAL ARTERIES WERE ACCESSED WITH ULTRASOUND AND 6FR X 90CM SHEATHS WERE PLACED. A 0.014 300CM RUNTHROUGH NS WIRE (TERUMO MEDICAL) WAS PLACED INTO THE RIGHT BRACHIOCEPHALIC ARTERY EXTENDING THROUGH THE RIGHT COMMO

  Patient problems: Diminished Pulse Pressure

  MAUDE report 10572192 ↗