AngioDynamics 25186Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI H965251860), received between Apr 20, 2016 and May 14, 2021 — classified as 16 deaths, 11 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  AN ANGIODYNAMICS SENIOR CLINICAL SCIENCE LIASON REPORTED AN ISSUE WITH AN ANGIOVAC CANNULA WITH DILATOR (20 DEGREE ANGLE). THE FOLLOWING WAS REPORTED: (B)(6) YEAR OLD MALE, WHO RECEIVED THE MODERNA COVID-19 VACCINE ON (B)(6) 2021. PATIENT PRESENTED TO THE ER WITH SWELLING IN HIS LEFT LEG THAT STARTED 3 DAYS PRIOR. CTA OF THE CHEST SHOWED EXTENSIVE BILATERAL PULMONARY EMBOLI IN THE DISTAL MAIN PULMONARY ARTERIES EXTENDING INTO THE SUB-SEGMENTAL BRANCHES. CT OF THE ABDOMEN AND PELVIS SHOWED EXTENSIVE VENOUS THROMBOSIS, INVOLVING THE IVC, LEFT COMMON ILIAC VEIN, AND LEFT FEMORAL VEIN. THE GEN 2. ANGIOVAC CANNULA BALLOON WAS PREPPED UTILIZING THE "DOUBLE NEGATIVE" METHOD, TO INSURE THE AIR HAD BEEN REMOVED FROM THE BALLOON. THE CANNULA WAS INSERTED FROM THE RIJ AND POSITIONED AT THE SVC/RA JUNCTION. THE BALLOON WAS INFLATED TO 1.5 ATM. AND FLOW WAS ESTABLISHED AT 2.2 L/MIN. INITIALLY UNDER FLUORO, THE BALLOON FULLY EXPANDED AND FUNNEL PETALS WERE OPPOSED, BUT NOT FULLY OPENED. THE BALLOON WAS DEFLATED, A "DOUBLE NEGATIVE" WAS PERFORMED A SECOND TIME, THEN THE BALLOON WAS REINFLATED. THE CANNULA FUNNEL SHOWED THE "PETALS" TO BE OPEN, BUT NOT FULLY OPPOSED. FLOE RATES WERE GOOD, SO THE P

  Patient problems: Decreased Respiratory Rate

  MAUDE report 11824420 ↗
• MalfunctionOct 20, 2020Break; Break

  AN ANGIODYNAMICS TERRITORY MANAGER REPORTED THAT DURING A PATIENT'S PROCEDURE USING THE ANGIOVAC 20 DEGREE CANNULA, THE PHYSICIAN INFLATED THE FUNNEL (BALLOON) TO <2 ATMOSPHERES, AND THE FUNNEL (BALLOON) APPEARED TO HAVE TORN WHILE INSIDE THE PATIENT. (OVER INFLATION OF BALLOON, CAUSING IT TO BURST/TEAR). NONE OF THE BALLOON FRAGMENTED OFF DURING THE DEFLATION. THE DEVICE WAS WITHDRAWN AND SET ASIDE AND A NEW CANNULA WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT DUE TO THIS EVENT. THE REPORTED DEVICE HAS BEEN RETURNED TO THE MANUFACTURER AND AN INVESTIGATION INTO THE ROOT CAUSE FOR EVENT IS CURRENTLY IN PROGRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10706801 ↗
• InjurySep 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ANGIODYNAMICS CLINICAL SPECIALIST REPORTED A PATIENT ISSUE WITH AN ANGIOVAC CANNULA, WITH DILATOR. DURING A PROCEDURE, WHEN THE OPERATOR ACTIVATED THE PUMP FOR ASPIRATION, THE PATIENT'S BLOOD PRESSURE (BP) CRASHED WITHIN 60 SECONDS. THE PATIENT WAS MANAGED BY ANESTHESIA AND THE ANGIOVAC WAS USED FOR ABOUT 45 SECONDS, AT ONLY 0.5LPM WITH A FLOW 800RPM. AT THIS TIME, THE PATIENT'S BP CRASHED AGAIN, REQUIRING AV TO BE SHUT OFF AND REMOVED WHILE ANESTHESIA AND STAFF MANAGED AND STABILIZED THE PATIENT AGAIN. A CT SCAN DISCOVERED THAT THE PATIENT HAD A RETROPERITONEAL BLEED IN THE GROIN, WHICH IS ASSUMED TO BE FROM A PREVIOUS STICK THE DAY BEFORE. ONCE THE PATIENT WAS STABILIZED WITH MEDICATION, BLOOD AND FLUID VOLUME, THEY WERE SENT TO THE CCU. THE PATIENT STILL REQUIRED SURGERY ON ANOTHER DAY. IT WAS INDICATED THAT THE REPORTED DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION AS THERE WAS NO INDICATION OF A DEVICE MALFUNCTION OR FAILURE.

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

  MAUDE report 10540801 ↗
• InjuryApr 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CLINICAL SPECIALIST REPORTED THAT A PATIENT CAME IN INTUBATED WITH KNOWN EFFUSION, AND UNRESPONSIVE. AN ANGIOVAC TEE WAS PLACED AND HEART VISUALIZED PRIOR TO DRAPING. THE MATERIAL WAS STILL PRESENT UPON INVESTIGATION. MATERIAL WAS MASSIVE IN APPEARANCE ON BASE OF TV WITH MOBILE PIECES AS WELL. PATIENT WAS THEN PREPPED AND DRAPED IN A STERILE MANNER. THE RFV AND LFV ACCESS WAS OBTAINED WITH MICROPUNCTURE AND ULTRASOUND GUIDANCE. HEPARIN WAS GIVEN AND BOTH SITES WERE UPSIZED RESPECTIVELY. ANGIOVAC PRIMED AND INSERTED INTO RFV AND BASELINE AND THRESHOLD FLOWS WERE ESTABLISHED IN THE IVC/RA JUNCTION AT ROUGHLY 2.7/LPM. THE PHYSICIAN ADVANCED THE ANGIOVAC TOWARDS THE TV TO ENGAGE THE MATERIAL. AFTER SEVERAL PASSES, TEE IMAGING WAS THEN INTERROGATED TO SEE IF MATERIAL WAS STILL THERE. MAJORITY OF THE MATERIAL ON THE TV WAS REMOVED, SO PHYSICIAN MOVED HIS FOCUS TO MATERIAL ON THE SEPTAL WALL. AFTER ENGAGING MATERIAL THERE AND CLEARING AREA, THE PATIENT'S SPO2 FELL TO 80. PHYSICIAN DECIDED TO SWEEP THE TV AGAIN JUST TO SEE IF HE COULD GET ANY ADDITIONAL MATERIAL. ANESTHESIOLOGIST BEGAN TO MANAGE THE LOW SPO2. PHYSICIAN LIKED THE RESULT AND DECIDED TO END PROCEDURE. BLOOD IN CIRCUIT WAS R

  Patient problems: Pneumothorax

  MAUDE report 10004281 ↗
• DeathApr 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ANGIOVAC PROCEDURE FOR A PATIENT WITH A HISTORY OF INTRAVASCULAR METASTATIC CANCER, MATERIAL WAS OBSERVED TO BE MOBILE AND NEAR THE RIGHT ATRIUM (RA) AND DOWN IN THE INFERIOR VENA CAVA (IVC). THE PHYSICIAN'S PLAN WAS TO GO RIGHT FEMORAL VEIN WITH THE ANGIOVAC DEVICE AND RETURN CANNULA IN THE LEFT FEMORAL VEIN. FLOWS OVER 300 WERE NOT ABLE TO BE ACHIEVED IN THE IVC. THEY PASSED WIRE AND CANNULA UP TO RA, AND FLOWS WERE STILL UNABLE TO BE ACHIEVED OVER A LITER. THEY PASSED WIRE AND CANNULA UP TO THE SVC, AND AGAIN FLOWS WERE UNDER A LITER. THE SURGICAL TEAM STARTED PERFORMING CARDIOPULMONARY RESUSCITATION (CPR) ON THE PATIENT. THEY WERE ABLE TO GET RETURN OF SPONTANEOUS CIRCULATION (ROSC). THE PHYSICIAN DECIDED TO GO BACK ON PUMP WHILE IN THE RIGHT ATRIUM. MATERIAL WAS SEEN IN THE FILTER AND THEY WERE ABLE TO PULL OUT ON SUCTION AND GET MATERIAL ON THE SURGICAL FIELD FROM THE ANGIOVAC CANNULA. AGAIN, CPR WAS RESUMED. THEN ROSC WAS ACHIEVED, AND THEY WENT BACK ON PUMP. THIS WAS REPORTED TO HAVE OCCURRED A FEW MORE TIMES, HOWEVER, THE PHYSICIAN PRONOUNCED THE PATIENT DECEASED IN THE OPERATING ROOM. THE TREATING PHYSICIAN REPORTED THAT THERE WAS NO ALLEGAT

  Patient problems: Death

  MAUDE report 9939845 ↗
• InjuryFeb 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: ANGIOVAC (AV, GENERATION 2) CASE WITH MATERIAL IN THE RV. ADHERED TO THE WALL. NON MOBILE. ALMOST OBSTRUCTING THE RVOT. NO PRE-CASE PLANNING OR IMAGES WERE REVIEWED BEFORE THE PROCEDURE. BOTH SURGEON AND I WERE UNAVAILABLE TO PRE-CASE PLAN. I RECEIVED A TEXT LATE THE NIGHT BEFORE ON NEW YEARS DAY ABOUT THE CASE AND IT WAS SCHEDULED FOR FIRST THING IN THE MORNING. THIS WAS THE DOCTORS SECOND/THIRD CASE. PATIENT HAS A HISTORY OF CANCER ALONG WITH OTHER COMORBIDITIES. PREVIOUS SURGERIES - CABG X4 (18 YEARS AGO) (B)(6) MALE. THE PATIENT DID NOT WANT TO HAVE OPEN HEART SURGERY AGAIN. ONCE TEE PROBE WAS INSERTED WE DISCUSSED THE CASE. HIS GOAL WAS TO DEBULK AS MUCH AS POSSIBLE. I EXPLAINED THE DIFFICULTIES OF THE CASE WITH CONCERNS ABOUT CROSSING THE VALVE AND SET EXPECTATIONS LOW FOR THE PROCEDURE DUE TO THE APPEARANCE AND LOCATION OF THE MASS THAT IT WOULD NOT BE LIKELY THAT THIS WOULD BE A SUCCESSFUL CASE. SURGEON DISCUSSED HIS PLAN FOR THE CASE WHICH WAS TO PLACE A WIRE ACROSS THE TRICUSPID VALVE, THROUGH THE RVOT AND INTO THE PA AND GO ON PUMP IN THE RV TO GET OUT AS MUCH MATERIAL AS POSSIBLE. ACCESS POINTS WERE 26F GDS SHEATH THROUGH THE RIJ AND RETURN IN THE LFV. ACCE

  Patient problems: Bradycardia; Cardiac Arrest; Low Blood Pressure/ Hypotension; Ventricular Tachycardia

  MAUDE report 9701008 ↗
• MalfunctionJan 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: ANGIOVAC (AV, GENERATION 2) CASE WITH MATERIAL IN THE RV. ADHERED TO THE WALL. NON MOBILE. ALMOST OBSTRUCTING THE RVOT. NO PRE-CASE PLANNING OR IMAGES WERE REVIEWED BEFORE THE PROCEDURE. BOTH SURGEON AND I WERE UNAVAILABLE TO PRE-CASE PLAN. I RECEIVED A TEXT LATE THE NIGHT BEFORE ON NEW YEARS DAY ABOUT THE CASE AND IT WAS SCHEDULED FOR FIRST THING IN THE MORNING. THIS WAS THE DOCTORS SECOND/THIRD CASE. PATIENT HAS A HISTORY OF CANCER ALONG WITH OTHER COMORBIDITIES. PREVIOUS SURGERIES CABG X4 (18 YEARS AGO) (B)(6) MALE. THE PATIENT DID NOT WANT TO HAVE OPEN HEART SURGERY AGAIN. ONCE TEE PROBE WAS INSERTED WE DISCUSSED THE CASE. HIS GOAL WAS TO DEBULK AS MUCH AS POSSIBLE. I EXPLAINED THE DIFFICULTIES OF THE CASE WITH CONCERNS ABOUT CROSSING THE VALVE AND SET EXPECTATIONS LOW FOR THE PROCEDURE DUE TO THE APPEARANCE AND LOCATION OF THE MASS THAT IT WOULD NOT BE LIKELY THAT THIS WOULD BE A SUCCESSFUL CASE. SURGEON DISCUSSED HIS PLAN FOR THE CASE WHICH WAS TO PLACE A WIRE ACROSS THE TRICUSPID VALVE, THROUGH THE RVOT AND INTO THE PA AND GO ON PUMP IN THE RV TO GET OUT AS MUCH MATERIAL AS POSSIBLE. ACCESS POINTS WERE 26F GDS SHEATH THROUGH THE RIJ AND RETURN IN THE LFV. ACCESS

  Patient problems: Cardiac Arrest

  MAUDE report 9611618 ↗
• MalfunctionOct 11, 2019Unsealed Device Packaging; Unsealed Device Packaging

  AS REPORTED: ANGIOVAC STERILE PACKAGE HAD AN OPEN SEAL ALONG THREE SIDES OF THE HARDPACK TRAY. KIT WAS SET ASIDE AND A NEW OF THE SAME WAS USED TO COMPLETE THE PROCEDURE. NO HARM OR INJURY TO THE PATIENT DUE TO THIS EVENT. THE REPORTED DEFECTIVE DISPOSABLE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9179121 ↗
• InjurySep 12, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  AS REPORTED: RIJ/LFV ACCESS WAS OBTAINED AND THE AV CANNULA WAS ADVANCED TO THE SVC/RA JUNCTION AND PERFUSION CAME ON PUMP. 1L OF FLOW WAS ACHIEVED AND MATERIAL WAS ENGAGED WITH SOME SUCCESS OF EXTRACTION, HOWEVER THE PATIENT DID NOT TOLERATE WELL. BP IMMEDIATELY BEGAN TO DROP EVERY TIME FLOW WAS ATTEMPTED. AFTER GIVING FLUIDS AND PRESSORS, SHE CONTINUED TO DECLINE. AFTER FURTHER INSPECTION, IT WAS NOTICED THAT THERE WAS SOME ABDOMEN SWELLING AND A VENOGRAM WAS PERFORMED THROUGH THE ARTERIAL RETURN CANNULA IN THE LFV TO DISCOVER A DISSECTED EXTERNAL ILIAC VEIN. THE PROCEDURE WAS ABORTED AT THIS TIME AND THE PHYSICIAN WAS ABLE TO SUCCESSFULLY TAMPONADE THE AREA OF THE DISSECTION WITH THE PATIENT STABILIZING. IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 9005926 ↗
• InjuryAug 26, 2019Gas/Air Leak; Gas/Air Leak

  AS REPORTED: DURING ANGIOVAC PROCEDURE, AIR BUBBLES WERE OBSERVED IN THE RETURN CIRCUIT INSIDE THE PATIENT'S RIGHT ATRIUM (RA). PROCEDURE NOTES: ACCESS SITES: 26FR GORE DRYSEAL SHEATH (2633DSF) - RFV, 19FR RE-INFUSION CANNULA - LFV. 30,000 IU TOTAL HEPARIN HIGHEST MEASURED ACT: 346 SECONDS. TEE WAS ADVANCED BY CARDIAC ANESTHESIA AND THE TV WAS VISUALIZED. TEE IMAGING SHOWED MATERIAL ON THE SUPERIOR AND INFERIOR LEAFLETS OF THE PT'S. TV. THE PT. WAS PREPPED AND DRAPED IN A STERILE MANNER. THE RFV WAS ACCESSED, PRECLOSED AND SERIALLY DILATED UP TO A 26FR DSF. THE LFV WAS ACCESSED, PRECLOSED AND SERIALLY DILATED UP TO AN 19FR RETURN CANNULA. THE AV CANNULA WAS ADVANCED INTO THE INFRAHEPATIC IVC, AND FUNNEL WAS DEPLOYED. AN ACT >300 SECONDS WAS CONFIRMED, CIRCUIT WAS PRIMED, AND THEN OPTIMAL FLOW WAS ACHIEVED (3L). THE PHYSICIAN ADVANCED THE AV CANNULA TO THE TV AND ATTEMPTED TO ENGAGE THE MATERIAL WITH TEE GUIDANCE. THE PHYSICIAN CHOSE TO SUTURE ONE PETAL OF THE ANGIOVAC CANNULA TO AID IN DIRECTING THE CANNULA TOWARDS THE TV MATERIAL. THE CANNULA ENGAGED THE MATERIAL WHICH WAS CONFIRMED BY TEE AND A SHARP DROP IN FLOWS TO .5L, REBOUNDING BACK TO OPTIMAL FLOW WHEN THE CANNULA WAS PULLE

  Patient problems: Air Embolism

  MAUDE report 8932202 ↗
• InjuryMar 29, 2019Human-Device Interface Problem; Human-Device Interface Problem

  AS REPORTED DURING AN ANGIOVAC PROCEDURE THE PHYSICIAN DAMAGED THE FEMORAL VEIN (VESSEL PERFORATION) RESULTING IN BLEEDING IN THE PATIENT'S STOMACH. UPON COMPLETION OF THE CASE, THE CANNULA WAS REMOVED, THE BLOOD RETURNED TO THE PATIENT VIA BOLUS FLUSH AND THE SITES WERE CLOSED WITH LIGHT PRESSURE HELD UNTIL HEMOSTASIS WAS ACHIEVED. THE ANGIODYNAMICS CLINICAL SPECIALIST PRESENT DURING THE CASE INDICATED THAT THERE WAS "NO MALFUNCTION OF THE ANGIOVAC DEVICE.".

  Patient problems: Perforation of Vessels

  MAUDE report 8466010 ↗
• DeathFeb 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, "(B)(6) OBESE MALE PATIENT CAME TO THE HOSPITAL WITH A SADDLE PE, THROMBUS INTO LEFT PA AS WELL AS TUMBLING RIGHT ATRIAL THROMBUS. PLAN WAS TO REMOVE TUMBLING RIGHT ATRIAL THROMBUS WITH ANGIOVAC. SURGERY WAS NOT AN OPTION AS HIS RIGHT VENTRICULAR STRAIN WAS QUITE HIGH AND HE WOULDN'T HAVE SURVIVED OPEN HEART SURGERY ACCORDING TO THE CT SURGEON. THE INTERVENTIONAL CARDIOLOGIST SUCCESSFULLY ASPIRATED OVER 40CM OF THROMBUS AND COMPLETED THE CASE IN THE HOPE OF MINIMIZING ADDITIONAL CLOT BURDEN ON THE LUNGS. THE PATIENT WAS STABLE DURING THE ENTIRE PROCEDURE AND IMMEDIATELY AFTER, BUT CODED UPON ARRIVAL IN THE CVICU. ATTEMPTS TO REVIVE HIM WERE UNSUCCESSFUL. THE PATIENT DEATH IS NOT RELATED TO THE PRODUCT (ANGIOVAC) AT ALL." THE DEVICE USED DURING THE PROCEDURE WAS DISCARDED AT THE HOSPITAL.

  Patient problems: Sudden Cardiac Death

  MAUDE report 8367602 ↗
• DeathFeb 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED BY ANGIODYNAMICS' CLINICAL SPECIALIST WHO WAS PRESENT AT THE PROCEDURE: PATIENT HISTORY: FEMALE (B)(6), REFERRED FROM (B)(6) BY DR. (B)(6), FOR EVALUATION AND RECOMMENDATION FOR A PROBLEM RELATED TO HER PACEMAKER SYSTEM. THE PATIENT'S SCANS, NOTES AND OTHER SPOT INFORMATION, HAVE BEEN REVIEWED. THE PATIENT HAD A RIGHT SIDED SYSTEM, WHICH ARE AROUND 20 YEARS OLD AND HAD FAILED ATTEMPTS AT EXTRACTION IN 2011. THE LEADS ARE CURRENTLY CAPPED. SHE HAS A LEFT-SIDED DUAL CHAMBER PACEMAKER AND LEADS, WHICH WERE IMPLANTED IN 2011 AND SHE IS PACEMAKER DEPENDENT WITH UNDERLYING COMPLETE HEART BLOCK. HER BATTERY IS NEARING COMPLETION. IN ADDITION, SHE HAS DEVELOPED A SUPERIOR VENA CAVA SYNDROME, RELATED TO NARROWING OF THE SUPERIOR VENA CAVA, RELATED TO HER PREVIOUS SURGERIES AND INDWELLING LEADS. THE PATIENT IS VERY UNCOMFORTABLE AT HER FACE IS SWOLLEN. SHE APPARENTLY HAS A RELATIVELY NORMAL EJECTION FRACTION. THE PATIENT HAD A CORONARY ANGIOGRAM IN 2016, WHICH SHOWED NO CRITICAL LESIONS, BUT WAS COMPLICATED, BY BLEEDING IN THE RIGHT FEMORAL ARTERY PSEUDOANEURYSM, WHICH WAS TREATED WITH SURGERY. SHE STILL HAS A HOST OF OTHER COMORBIDITIES. RECOMMENDATION

  Patient problems: Sudden Cardiac Death

  MAUDE report 8355029 ↗
• InjuryNov 27, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  EVENT DESCRIPTION AS PROVIDED BY ANGIODYNAMICS' MEDICAL "LIASON": (B)(6) AFRICAN AMERICAN FEMALE WITH HISTORY OF OBESITY, (B)(6), AND ESRD PRESENTED WITH LARGE MOBILE RIGHT ATRIAL MASS EXTENDING FROM THE SUPERIOR VENA CAVA TO THE TRICUSPID VALVE. TRICUSPID VALVE DOES NOT APPEAR TO BE INVOLVED. MASS SUSPECTED TO BE A FIBRIN SHEATH FROM PREVIOUS DIALYSIS CATHETER. PHYSICIAN STATED INTERNAL "JUGLUARS" ARE NOT ACCESSIBLE. PATIENT IS S/P DIALYSIS CATHETER PLACEMENT IN THE RIGHT FEMORAL VEIN. PATIENT WAS BROUGHT INTO THE OPERATING SUITE AND PLACED SUPINE ON THE PROCEDURE TABLE. PATIENT WAS INTUBATED AND TRANSESOPHAGEAL ECHO PERFORMED CONFIRMING LARGE MOBILE MASS PRESENT. PATIENT'S FULL CHEST AND ABDOMEN WERE PREPPED AND DRAPES APPLIED IN A STERILE FASHION. FLUOROSCOPY IMAGING WILL NOT BE UTILIZED PER PHYSICIAN'S ORDERS. THE ANGIOVAC CIRCUIT WAS ASSEMBLED AND PRIMED PER IFU. THE ANGIOVAC WAS PREPPED AND PRIMED PER IFU. THE BALLOON TIP WAS LUBRICATED WITH STERILE GEL. THE ANGIOVAC WAS PLACED OVER THE AMPLATZ SS 260CM WIRE INTO THE 26FR GORE DRYSEAL IN THE RIGHT FEMORAL VEIN. THE ANGIOVAC WAS ADVANCED OVER THE AMPLATZ SS CURVE TIP 260CM WIRE TO THE LEVEL OF THE IVC/RA JUNCTION. THE DILATOR

  Patient problems: Pericardial Effusion

  MAUDE report 8106288 ↗
• DeathSep 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: " PATIENT EXPIRED DURING ANGIOVAC PROCEDURE. A WIRE WAS ADVANCED THROUGH THE 16FR SHEATH AND A NEW SHEATH WAS ADVANCED OVER THE WIRE. WHILE ADVANCING THE NEW SHEATH THE PHYSICIAN HAD DIFFICULTY ADVANCING INTO THE IVC, BUT AFTER SOME MANIPULATION THE SHEATH WAS POSITIONED IN THE IVC SUPERIOR TO THE IVC FILTER AND PAST THE RA/IVC JUNCTION. DURING PLACEMENT THE PT.'S SYSTOLIC PRESSURE BEGAN TO DROP INTO THE 50'S MM/HG. ANESTHESIA GAVE A PRESSOR TO BOOST THE SYSTOLIC PRESSURE BUT IT CONTINUED TO DROP. WHEN THE SYSTOLIC PRESSURE DROPPED INTO THE 40'S MM/HG THE PT. BEGAN TO DROP HER O2 SATS. O2 SATURATION DROPPED TO 50%-60% AND PHYSICIAN CALLED A FULL CODE. PHYSICIAN ENDED THE ANGIOVAC PROCEDURE AND LIFE SAVING MEASURES WERE INITIATED BY THE CODE TEAM." RESPONSE FROM DR. (B)(6)- CAUSE OF DEATH MOST LIKELY " HEMORRHAGE RELATED TO IVC AND ANTICOAGULATION."

  Patient problems: Death

  MAUDE report 7842699 ↗
• DeathJun 26, 2018Material Rupture; Aspiration Issue; Material Rupture; Aspiration Issue

  DESCRIPTION: A (B)(6) MORBIDLY OBESE MALE WITH HISTORY OF MVA SPINAL TRAUMA AND REPAIR ON (B)(6) 2018. A PREVENTATIVE CONICAL IVC FILTER PLACED ON DATE OF TRAUMA. THE IVC FILTER WAS TILTED WITH THE HOOK EXTENDING INTO THE RIGHT RENAL VEIN. CT EXAM PERFORMED APPROXIMATELY TWO WEEKS AFTER PLACEMENT REVEALED LARGE THROMBUS FROM BILATERAL FEMORALS EXTENDING CEPHALICALLY TO THE RENAL VEINS. THE PATIENT WAS BROUGHT INTO THE IR SUITE AND PLACED SUPINE. AFTER PREP AND DRAPE OF THE BILATERAL INTERNAL JUGULAR REGION. MICROPUNCTURE ACCESS PERFORMED ON BOTH LEFT AND RIGHT INTERNAL JUGULARS. TWELVE-THOUSAND ("12,0000") UNITS OF HEPARIN WAS GIVEN. SERIAL DILATATION PERFORMED IN THE LEFT INTERNAL JUGULAR. AN 18FR EDWARDS FEM FLEX ARTERIAL RETURN CANNULA WAS PLACED AND SECURED WITH SUTURE IN THE LEFT INTERNAL JUGULAR VEIN. THE RETURN CANNULA WAS CONNECTED TO THE PRIMED CIRCUIT. SERIAL DILATATION OF THE RIGHT INTERNAL JUGULAR PERFORMED. A 26FR GORE DRYSEAL WAS PLACED IN THE RIGHT INTERNAL JUGULAR EXTENDING TO THE RA/IVC JUNCTION. ACT PERFORMED RESULTING IN A 268 SECOND RESULT. ADDITIONAL 5,000 UNITS OF HEPARIN GIVEN. A 260 CM AMPLATZ WIRE WAS PLACED IN THE GORE DRYSEAL AND EXTENDED TO THE LEFT FEMO

  Patient problems: Death; Pulmonary Embolism

  MAUDE report 7637269 ↗
• InjuryMar 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, "MIDDLE AGED FEMALE, HX OF BREAST CA AND RECENTLY DISCOVERED INFECTED ICD (PACER AND LEAD WIRES). UPON ANGIOVAC CLINICAL ARRIVAL, THE PATIENT WAS POSITIONED SUPINE ON THE OPERATING TABLE, ANESTHETIZED. PLAN TO REMOVE PACER BODY AND LEAD WIRES WHILE USING ANGIOVAC TO REMOVE THE UIM FROM PACER LEAD WIRE. PATIENT WAS ANESTHETIZED AND STABLE. USING TEE, THE UIM APPEARED TO BE MOBILE AND FRIABLE, APPROXIMATELY 1.5 CM IN LENGTH AND LOCATED ON THE PACER LEAD WIRE IN THE RA. ACCESS WAS OBTAINED IN THE RIJ AND RFV. A 26F X 33CM GORE DRYSEAL SHEATH WAS PLACED IN THE RIJ USING A STIFF AMPLATZ WIRE. A 17F MAQUET FEMORAL ARTERIAL RE-INFUSION CANNULA WAS PLACED USING A STIFF WIRE IN THE RFV. THE ANGIOVAC CANNULA AND OBTURATOR WERE INSERTED INTO THE DRYSEAL SHEATH OVER THE STIFF AMPLATZ WIRE AND PARKED IN THE SVC. DURING THE PLACEMENT OF THE ANGIOVAC CANNULA, ANOTHER PHYSICIAN WAS OPENING THE POCKET, ACCESSING THE ICD BODY AND PACER LEAD WIRES. THE PATIENT WAS GIVEN 14,000 U OF HEPARIN, SYSTEMICALLY TO PRODUCE AN ACT OF 338. A FLOW RATE OF 2.5 L/MIN WAS ACHIEVED WITH THE ANGIOVAC BEING UTILIZED IN THE SVC AND RA TO ENGAGE THE UIM. AT SEVERAL POINTS DURING THE PROCEDURE, THE PATIENT'S

  Patient problems: Cardiac Arrest

  MAUDE report 7317957 ↗
• DeathJan 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT DEATH FOLLOWING ANGIOVAC PROCEDURE. INDICATION FOR PROCEDURE - SVC LINE THROMBUS EXTENDING INTO THE RA (FROM DIALYSIS CATHETER). A (B)(6)-YEAR-OLD FEMALE WITH A HISTORY OF ESRD PRESENTED TO THE HOSPITAL WITH A PERSISTENT INFECTION AFTER BEING ON ANTIBIOTICS. A CT SCAN SHOWED MATERIAL IN THE SVC EXTENDING INTO THE RA. A TEE CONFIRMED THE SVC WAS APPROXIMATELY (B)(6) OCCLUDED, AND A LARGE MOBILE PORTION OF THE MATERIAL WAS EXTENDING INTO THE RA. PT. WAS ALSO MORBIDLY OBESE. ANY DEVICE MODIFICATION? - NONE. PT. HEMODYNAMICS AT ONSET OF PROCEDURE (STABLE, UNSTABLE, CRITICAL) - UNSTABLE, PT. HAD A SYSTOLIC IN THE MID 80'S AND WAS GIVEN PRESSORS TO BRING UP PRESSURE PRIOR TO GOING ON PUMP. CHRONICITY OF MATERIAL? - ACUTE / SEMI-ACUTE. ACCESS SITES? - RFV / LFV / RFA. CANNULA LOCATION IN BODY? - RA / SVC JUNCTION. ADJUNCTIVE DEVICES AND HOW WERE THEY USED? - NONE. DURATION OF CASE? - 5 MIN PUMP TIME. BRIEF SUMMARY OF CASE: ACCESS SITES: 26FR GORE DRYSEAL SHEATH ((B)(4)) - RFV, 5FR SHEATH - RFA (CENTRAL LINE ACCESS), 17FR RE-INFUSION CANNULA - LFV. PT. WAS PREPPED AND DRAPED IN A STERILE MANNER. THE PT. WAS PLACED UNDER CONSCIOUS SEDATION AND THE TTE IMAGES WERE OBTAINED AT THE SVC

  Patient problems: Death; Unspecified Infection

  MAUDE report 7225944 ↗
• DeathNov 21, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY ANGIODYNAMICS' CLINICAL SPECIALIST: HX: THROMBOSED IVC FILTER TO SUPERFICIAL FEMORAL VEIN SFV BILATERALLY. PATIENT HAD BILATERAL POPLITEAL SHEATHS IN PLACE PRIOR TO START OF CASE. PROCEDURE NOTES: THE PATIENT WAS PREPPED AND DRAPED IN STERILE FASHION AND THE EXISTING POPLITEAL SHEATHS WERE PREPPED AS WELL FOR ACCESS DURING THE CASE. HR, BP AND O2 SATS WERE STABLE (O2 SATS WERE RUNNING 99-100%) ACCESS POINTS WERE GAINED W NEEDLE, UNDER ULTRASOUND GUIDANCE. EACH ACCESS POINT WAS THEN DILATED UP TO THE REQUIRED FRENCH SIZE AS DISCUSSED IN THE PRE-CASE PLAN. ONCE THE 9FR SHEATH WAS IN PLACE IN THE LT IJ, THE SUPRA RENAL FILTER WAS PLACED AND REMAINED TETHERED DURING THE CASE. THE REINFUSION CANNULA WAS ATTACHED TO THE RETURN SIDE OF THE CIRCUIT USING A WET TO WET CONNECTION AND WAS FLUSHED. THE ANGIOVAC WAS THEN ATTACHED AND ALSO FLUSHED PRIOR TO INSERTING THROUGH THE DRY SEAL SHEATH AND INTO THE IVC. THE AV WAS THEN TURNED ON AND FLOW RATES WERE MAXIMIZED AT A RATE OF 2.5LPM. IT WAS THEN ADVANCED THROUGH THE INFRA RENAL FILTER AND PASSES WERE MADE FROM THE PROXIMAL IVC TO THE DISTAL IVC TO REMOVE THE THROMBUS. A VENOGRAM WAS DONE SHOWING THE IVC TO BE CLEAR OF THROMBUS.

  Patient problems: Death

  MAUDE report 7048913 ↗
• DeathNov 2, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED PATIENT UNDERWENT A PROCEDURE UTILIZING AN ANGIOVAC DUE TO A PULMONARY EMBOLISM. ANGIODYNAMICS SALES REPRESENTATIVE WAS PRESENT DURING THE CASE, AND AN ANGIODYNAMICS CLINICAL SPECIALIST PROVIDED FACETIME SUPPORT. THE RIGHT IJ WAS ACCESSED FOR THE 26F SHEATH AND THE REINFUSION CANNULA WAS PLACED IN THE LEFT GROIN. THE REINFUSION SIDE OF THE CIRCUIT WAS CONNECTED TO THE REINFUSION CANNULA. ONCE THE ANGIOVAC WAS POSTIONED IN THE PA, THE BALLOON FUNNEL TIP WAS INFLATED AND THEY WENT ON PUMP. NO EVIDENCE OF DEVICE MALFUNCTION WAS PRESENT DURING THE CASE. AFTER A FEW MINUTES OF ATTEMPTING TO REMOVED THE MATERIAL WITH THE ANGIOVAC DEVCIE, AND THE PHYSICIANS FELT THAT THEY HAD ACCOMPLISHED EVERYTHING THAT THEY WERE GOING TO ACCOMPLISH, THE CANNULA WAS REMOVED. AT THIS TIME THE PATIENT CODED, THEN EXPIRED. NO DEVICE SAMPLE WILL BE RETURNED. DEVICE MALFUNCTION WAS NOT INDICATED.

  Patient problems: Death; Pulmonary Embolism

  MAUDE report 6997073 ↗
• InjuryOct 2, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY ANGIODYNAMICS CLINICAL SPECIALIST: "APPROXIMATELY (B)(6) YO MALE BROUGHT TO THE CATH LAB FOR ANGIOVAC ASSISTED EXTRACTION OF TRICUSPID VALVE VEGETATION. LABS DISCUSSED WERE (VALUES APPROXIMATE FROM RECOLLECTION) A POTASSIUM OF 5.6, A HGB OF 7.8 AND AN ELEVATED CREATININE. THE PATIENT MISSED DIALYSIS THE DAY BEFORE, THE PHYSICIANS CHOSE TO PROCEED WITH PROCEDURE AND DIALYZE AFTER. ALSO CHOSE TO GIVE BLOOD DURING DIALYSIS DUE TO PATIENTS ELEVATED POTASSIUM, WILL SUPPORT WITH SALINE DURING THE PROCEDURE FOR VOLUME. PATIENT WAS PLACED UNDER GENERAL ANESTHESIA AND INTUBATED. THE PATIENT'S BLOOD PRESSURE WAS NOTED TO BE IN THE 80'S SYSTOLIC. TEE WAS PERFORMED, SHOWING THE MATERIAL ON THE TV UNCHANGED. THE PHYSICIAN CHOSE TO MOVE FORWARD WITH THE PROCEDURE AT THIS TIME AND ACCESS POINTS TO THE RIGHT INTERNAL JUGULAR VEIN AND THE RIGHT FEMORAL VEIN WERE ESTABLISHED AND HEPARIN WAS ADMINISTERED. THE ANGIOVAC CANNULA DISTAL TIP WAS RESHAPED BY WARMING THE DEVICE TO CREATE A 90 DEGREE CURVE, THEN PLACING IN COOL SALINE TO HELP HOLD THE SHAPE. THE RFV WAS UPSIZED TO A 17FR. ARTERIAL RETURN CANNULA. THE RIJ ACCESS WAS UPSIZED TO A 26FR. GORE DRYSEAL SHEATH, ADVANCED INTO THE IVC

  Patient problems: Cardiac Arrest; Perforation of Vessels

  MAUDE report 6908277 ↗
• DeathJun 22, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ANGIODYNAMICS HAS BECOME AWARE OF A PATIENT DEATH FROM COMPLICATIONS FROM A PE. THE PE OCCURRED TWO DAYS AFTER AN ELDERLY MALE WAS BEING TREATED FOR SVC SYNDROME WITH AN ANGIOVAC. THE PHYSICIAN, DR. (B)(6) HAS STATED, IN EMAIL, " I DON'T REALLY THINK IT WAS RELATED TO THE DEVICE, I THINK WE DID PRETTY MUCH EVERYTHING WE COULD." WHEN ASKED IF ANYTHING WAS DONE TO RESOLVE THE PE AT THE TIME, HE SAID, "WE JUST PUT HIM ON HEPARIN, THERE WAS NO PROCEDURE THAT WOULD HAVE BEEN ABLE TO RETRIEVE IT OR LYSE IT." DETAILS OF THE PROCEDURE ARE AS FOLLOWS: PRE-CASE DISCUSSIONS INCLUDED ACCESS PLANNING AND POTENTIAL ISSUES. THE RFV WAS USED FOR ASPIRATION AND THE LFV WAS USED FOR REINFUSION. INITIAL VENOGRAM SHOWED LITTLE CLOT PER DR. (B)(6) BUT SIGNIFICANT STENOSIS. ONCE THE PATIENT WAS HEPARINIZED AND AN ACT > 300 SECONDS OBTAINED AN 18 FR. ARTERIAL REINFUSION CANNULA WAS PLACED IN THE LFV AND A 26 FR. GORE DRYSEAL PLACED IN THE RFV. UNDER FLUOROSCOPIC GUIDANCE THE CANNULA WAS PLACED IN THE MID RIGHT ATRIUM AND THE FLOW OPTIMIZED AT 3.5 LITERS PER MIN. THE CANNULA WAS THEN ADVANCED INTO THE SVC WHICH RESULTED IS NO FLOW WHICH WAS RESOLVED BY MOVING THE CANNULA BACK TOWARDS THE OSTIA. SEVERAL PA

  Patient problems: Death; Pulmonary Embolism

  MAUDE report 6661295 ↗
• DeathFeb 13, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE PATIENT HAD A FATAL HEART ARREST THE DAY AFTER AN ANGIOVAC PROCEDURE. THE EXACT DATES OF THE PROCEDURE AND THE PATIENT DEATH ARE UNKNOWN AT THIS TIME. THE PATIENT HAD A PULMONARY EMBOLISM, HOWEVER THE PHYSICIAN DID NOT TRY TO USE THE ANGIOVAC TO TREAT THE PE. THE DEVICE WAS UTILIZED TO TREAT A RIGHT ATRIAL THROMBUS. THE PHYSICIAN DOES NOT BELIEVE THAT THE ANGIOVAC CONTRIBUTED TO THE PATIENT DEATH.

  Patient problems: Cardiac Arrest; Death

  MAUDE report 6326860 ↗
• DeathFeb 13, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, PHYSICIAN WAS UTILIZING AN ANGIOVAC TO TREAT A RIGHT ATRIAL THROMBUS. PATIENT ADDITIONALLY HAD A PULMONARY EMBOLISM, WHICH WAS NOT BEING TREATED WITH THE DEVICE. FOLLOWING THE ANGIOVAC PROCEDURE, THE PATIENT HAD A FATAL HEART ARREST. IT WAS NOT REPORTED THAT EITHER THE DEVICE MALFUNCTIONED OR THAT USE OF THE DEVICE DURING THE PROCEDURE CONTRIBUTED TO THE OUTCOME OF THE EVENT.

  Patient problems: Cardiac Arrest; Death

  MAUDE report 6326800 ↗
• InjuryDec 6, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PT. WAS PREPPED AND DRAPED IN A STERILE MANNER. A 26FR GORE DRY SEAL SHEATH WAS INTRODUCED INTO THE RIJ, AND A 26FR GORE DRY SEAL SHEATH WAS INTRODUCED INTO THE RFV. A 17FR ARTERIAL RE-INFUSION CANNULA WAS INTRODUCED INTO THE RFV THROUGH THE GORE DRY SEAL SHEATH. A 6FR SHEATH WAS INTRODUCED INTO THE RFV FOR ADJUNCTIVE DEVICES, AND A 10FR SHEATH WAS INTRODUCED INTO THE LFV FOR ICE. A 5FR SHEATH WAS ALSO INTRODUCE INTO THE LFA AS A PRECAUTIONARY MEASURE. THE AV CANNULA WAS THEN ADVANCED OVER AN AMPLATZ SUPER STIFF WIRE TO THE SVC / RA JUNCTION, AND FUNNEL WAS DEPLOYED. AN ACT GREATER THAN 300 SECONDS WAS CONFIRMED, CIRCUIT WAS PRIMED, AND THEN OPTIMAL FLOW WAS ACHIEVED (3.0L). THE AV CANNULA WAS ADVANCED INTO THE RA AND THE UIM WAS ENGAGED WHERE WE GOT "CHATTER" AND OUR FLOW RATES FLUCTUATING FROM 1L - 3.0L. DR. (B)(6) CONTINUED TO ENGAGE THE UNDESIRABLE INTRAVASCULAR MATERIAL (UIM) WHILE OBSERVING PROGRESS UNDER TEE. ECHO CONFIRMED THERE WAS ABOUT A 20% REDUCTION IN THE UIM AND NO SIGNIFICANT CHANGES WITH CONTINUED ENGAGEMENT OF THE AV. DR. (B)(6) PULLED BACK THE AV TO THE SVC / RA JUNCTION AND FLOWS WERE INCREASED TO 4.0L AND THE UIM WAS RE-ENGAGED WITH THE AV CANNULA, WITH ECHO RE

  Patient problems: Pulmonary Embolism

  MAUDE report 6148999 ↗