AlphaVac 25-302Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI H787253020), received between May 20, 2022 and Oct 16, 2025 — classified as 12 deaths, 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Advance” (4 reports).

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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• DeathOct 16, 2025Material Deformation; Material Deformation

  AN ANGIODYNAMICS SENIOR TERRITORY MANAGER REPORTED RECEIVING NOTIFICATION FROM A PHYSICIAN, THAT THE FOLLOWING EVENT OCCURRED DURING AN ALPHAVAC PULMONARY EMBOLISM PROCEDURE: " I WAS CONTACTED BY (B)(6) TO SEE IF I COULD COVER A PE CASE. IT WAS A 2.5 HOUR DRIVE SO THE HOSPITAL WAS PREPARING TO START THE CASE KNOWING I WOULD ARRIVE AT ROUGHLY 2PM. THE PHYSICIANS, DR. (B)(6), WERE SCRUBBED IN WHEN I ARRIVED. THEY HAD A PIGTAIL CATHETER IN THE PATIENTS PA. THE PATIENT WAS INTUBATED BUT I DID NOT GET ANY ADDITIONAL INFORMATION AS TO WHAT LEAD TO HER INTUBATION OR HOW SHE PRESENTED WITH HER PE. I DID NOT GET HER EXACT DOB BUT THE STAFF SAID SHE WAS IN HER LATE 70'S AND THE PHYSICIAN SAID THAT SHE "HAD MANY MEDICAL PROBLEMS IN ADDITION TO HER PE". THE PHYSICIANS DID NOT HAVE ANY TROUBLE USING ALPHAVAC. THEY WERE ABLE TO DELIVER THE OVER SHEATH AND MANIPULATE THE CANNULA WITHOUT TROUBLE IN THE RIGHT LUNG AND IN THE LEFT LUNG. WHILE IN THE LEFT LUNG DR. (B)(6) NOTICED THE CANNULA WAS KINKED ON THE MOST PROXIMAL END NEAR THE HANDLE FROM HOLDING THE HANDLE AT AN ANGLE THAT CAUSED THE KINK. THEY REMOVED THE CATHETER, DELIVERED A PIGTAIL TO THE MAIN PA AND TOOK AN ANGIO. THEY NOTICED THAT THER

  Patient problems: Pulmonary Embolism

  MAUDE report 23309621 ↗
• DeathFeb 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ANGIODYNAMICS TERRITORY MANAGER REPORTED A PATIENT DEATH OCCURRED, AFTER USE OF AN ALPHAVAC MULTIPURPOSE MECHANICAL ASPIRATOR F18 C85. THE PATIENT ULTIMATELY EXPIRED AS A RESULT OF A 'MASSIVE PULMONARY EMBOLISM.' THE PHYSICIAN STATED THAT THE PATIENT'S EXPIRATION IS IN NO WAY ASSOCIATED WITH THE ALPHAVAC DEVICE BUT DUE TO PATIENT COMORBIDITIES. THE FOLLOWING WAS REPORTED: "35 YEAR OLD MALE PT,WITH FACTOR 5 DEFICIENCY, NON COMPLIANT WITH MEDICATIONS FOR 6 MONTHS, ADMITTED FOR BILATERAL AND SADDLE PE. PT CONSENTED BY PHYSICIAN, TIME OUT STATED, PT PREPPED AND DRAPED IN STERILE FASHION, RIGHT FEMORAL VENOUS ACCESS WITH 26F GORE DRYSEAL. PT ON HEPARIN GTT AND PHYSICIAN GAVE HEPARIN BOLUS, PHYSICIAN STATES "WE DO NOT NEED TO CHECK ACTS". PT PRE PA PRESSURES WERE 65/18/35 O2 98% HR IN 120'S. PHYSICIAN NAVIGATED ALPHAVAC F1885 TO LUNGS AND BEGAN MECHANICAL ASPIRATION. CLOT REMOVED WAS DARK AND BRIGHT RED IN COLOR, GELATINOUS IN TEXTURE. BLOOD WAS FILTERED AND RETURNED BY PHYSICIAN. PHYSICIAN TOOK POST ANGIOGRAMS, CLOT BURDEN WAS DECREASED. ALPHAVAC DEVICE WAS REMOVED FROM BODY AS PHYSICIAN STATED, "I AM FINISHED REMOVING CLOT AND WILL ALLOW HEPARIN TO WORK." PHYSICIAN ASSESSED DEVICE O

  Patient problems: Pulmonary Embolism

  MAUDE report 21469457 ↗
• DeathFeb 10, 2025Difficult to Advance; Difficult to Advance

  AN ANGIODYNAMICS SENIOR TERRITORY MANAGER REPORTED THAT A PATIENT EXPIRED DURING AN OFF-LABEL ALPHAVAC PROCEDURE. IT WAS REPORTED THAT THE MASS THAT WAS BEING REMOVED HAD EMBOLIZED TO THE LUNG, RESULTING IN THE PATIENT'S EXPIRATION. THE FOLLOWING WAS REPORTED FROM THE TECH WHO WAS SCRUBBED IN FOR THE PROCEDURE: "THE PATIENT WAS A 26 YEAR OLD MALE WITH ADVANCED METASTATIC CANCER AND HE HAD A TUMOR THAT WAS BLOCKING HIS IVC/RA. HE WAS TERMINAL BUT THIS TUMOR WAS CAUSING RENAL AND LIVER FAILURE AND THEY WANTED TO IMPROVE HIS QUALITY OF LIFE BEFORE HE DIED. DR. (B)(6) STARTED OUT BY TRYING TO SNARE THE TUMOR PIECE BY PIECE WITH AN ENSNARE AND THE ONO DEVICE. EARLY IN THE PROCEDURE WE SAW ON THE ECHO HOW HE HAD PULLED OFF A BIG PIECE, BUT IT FELL OUT OF THE SNARE AND WE DIDN'T KNOW WHERE I WENT. (B)(6) WENT ON AND WAS TAKING PIECES OF THE TUMOR OUT. HE SWITCHED FROM THE SNARE TO THE ALPHAVAC AT SOME POINT (22FR) AND IT WORKED OKAY. WE HAD AN ISSUE WITH IT AT ONE POINT (B)(4) BUT I CAN'T REMEMBER WHAT HAPPENED WITH IT WHICH IS WHY WE OPENED ANOTHER ONE. THE PATIENT STARTED CODING AT ONE POINT AND WE OPENED THE 18FR VERSION (B)(4). THE DILATOR WOULDN'T PASS THROUGH THE WHOLE DEVICE AS MUC

  Patient problems: Pulmonary Embolism

  MAUDE report 21344915 ↗
• DeathFeb 10, 2025Difficult to Advance; Difficult to Advance

  AN ANGIODYNAMICS SENIOR TERRITORY MANAGER REPORTED THAT A PATIENT EXPIRED DURING AN OFF-LABEL ALPHAVAC PROCEDURE. IT WAS REPORTED THAT THE MASS THAT WAS BEING REMOVED HAD EMBOLIZED TO THE LUNG, RESULTING IN THE PATIENT'S EXPIRATION. THE FOLLOWING WAS REPORTED FROM THE TECH WHO WAS SCRUBBED IN FOR THE PROCEDURE: "THE PATIENT WAS A 26 YEAR OLD MALE WITH ADVANCED METASTATIC CANCER AND HE HAD A TUMOR THAT WAS BLOCKING HIS IVC/RA. HE WAS TERMINAL BUT THIS TUMOR WAS CAUSING RENAL AND LIVER FAILURE AND THEY WANTED TO IMPROVE HIS QUALITY OF LIFE BEFORE HE DIED. DR. (B)(6) STARTED OUT BY TRYING TO SNARE THE TUMOR PIECE BY PIECE WITH AN ENSNARE AND THE ONO DEVICE. EARLY IN THE PROCEDURE WE SAW ON THE ECHO HOW HE HAD PULLED OFF A BIG PIECE, BUT IT FELL OUT OF THE SNARE AND WE DIDN'T KNOW WHERE I WENT. (B)(6) WENT ON AND WAS TAKING PIECES OF THE TUMOR OUT. HE SWITCHED FROM THE SNARE TO THE ALPHAVAC AT SOME POINT (22FR) AND IT WORKED OKAY. WE HAD AN ISSUE WITH IT AT ONE POINT (B)(4) BUT I CAN'T REMEMBER WHAT HAPPENED WITH IT WHICH IS WHY WE OPENED ANOTHER ONE. THE PATIENT STARTED CODING AT ONE POINT AND WE OPENED THE 18FR VERSION (B)(4). THE DILATOR WOULDN'T PASS THROUGH THE WHOLE DEVICE AS MUC

  Patient problems: Pulmonary Embolism

  MAUDE report 21344878 ↗
• DeathFeb 9, 2025Difficult to Advance; Difficult to Advance

  AN ANGIODYNAMICS SENIOR TERRITORY MANAGER REPORTED THAT A PATIENT EXPIRED DURING AN OFF-LABEL ALPHAVAC PROCEDURE. IT WAS REPORTED THAT THE MASS THAT WAS BEING REMOVED HAD EMBOLIZED TO THE LUNG, RESULTING IN THE PATIENT'S EXPIRATION. THE FOLLOWING WAS REPORTED FROM THE TECH WHO WAS SCRUBBED IN FOR THE PROCEDURE: "THE PATIENT WAS A 26-YEAR-OLD MALE WITH ADVANCED METASTATIC CANCER AND HE HAD A TUMOR THAT WAS BLOCKING HIS IVC/RA. HE WAS TERMINAL BUT THIS TUMOR WAS CAUSING RENAL AND LIVER FAILURE AND THEY WANTED TO IMPROVE HIS QUALITY OF LIFE BEFORE HE DIED. DR. (B)(6) STARTED OUT BY TRYING TO SNARE THE TUMOR PIECE BY PIECE WITH AN ENSNARE AND THE ONO DEVICE. EARLY IN THE PROCEDURE WE SAW ON THE ECHO HOW HE HAD PULLED OFF A BIG PIECE, BUT IT FELL OUT OF THE SNARE AND WE DIDN'T KNOW WHERE I WENT. (B)(6) WENT ON AND WAS TAKING PIECES OF THE TUMOR OUT. HE SWITCHED FROM THE SNARE TO THE ALPHAVAC AT SOME POINT (22FR) AND IT WORKED OKAY. WE HAD AN ISSUE WITH IT AT ONE POINT ((B)(4)) BUT I CAN'T REMEMBER WHAT HAPPENED WITH IT WHICH IS WHY WE OPENED ANOTHER ONE. THE PATIENT STARTED CODING AT ONE POINT AND WE OPENED THE 18FR VERSION ((B)(4)). THE DILATOR WOULDN'T PASS THROUGH THE WHOLE DEVICE AS

  Patient problems: Pulmonary Embolism

  MAUDE report 21341037 ↗
• DeathFeb 9, 2025Difficult to Advance; Difficult to Advance

  AN ANGIODYNAMICS SENIOR TERRITORY MANAGER REPORTED THAT A PATIENT EXPIRED DURING AN OFF-LABEL ALPHAVAC PROCEDURE. IT WAS REPORTED THAT THE MASS THAT WAS BEING REMOVED HAD EMBOLIZED TO THE LUNG, RESULTING IN THE PATIENT'S EXPIRATION. THE FOLLOWING WAS REPORTED FROM THE TECH WHO WAS SCRUBBED IN FOR THE PROCEDURE: "THE PATIENT WAS A 26-YEAR-OLD MALE WITH ADVANCED METASTATIC CANCER AND HE HAD A TUMOR THAT WAS BLOCKING HIS IVC/RA. HE WAS TERMINAL BUT THIS TUMOR WAS CAUSING RENAL AND LIVER FAILURE AND THEY WANTED TO IMPROVE HIS QUALITY OF LIFE BEFORE HE DIED. DR. (B)(6) STARTED OUT BY TRYING TO SNARE THE TUMOR PIECE BY PIECE WITH AN ENSNARE AND THE ONO DEVICE. EARLY IN THE PROCEDURE WE SAW ON THE ECHO HOW HE HAD PULLED OFF A BIG PIECE, BUT IT FELL OUT OF THE SNARE AND WE DIDN'T KNOW WHERE I WENT. (B)(6) WENT ON AND WAS TAKING PIECES OF THE TUMOR OUT. HE SWITCHED FROM THE SNARE TO THE ALPHAVAC AT SOME POINT (22FR) AND IT WORKED OKAY. WE HAD AN ISSUE WITH IT AT ONE POINT ((B)(4)) BUT I CAN'T REMEMBER WHAT HAPPENED WITH IT WHICH IS WHY WE OPENED ANOTHER ONE. THE PATIENT STARTED CODING AT ONE POINT AND WE OPENED THE 18FR VERSION ((B)(4)). THE DILATOR WOULDN'T PASS THROUGH THE WHOLE DEVICE AS

  Patient problems: Pulmonary Embolism

  MAUDE report 21341036 ↗
• DeathJan 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A TERRITORY MANAGER (TM) REPORTED AN ADVERSE EVENT DURING A PROCEDURE USING AN ALPHAVAC MULTIPURPOSE MECHANICAL ASPIRATOR F18 C85. THE FOLLOWING WAS REPORTED: " A PATIENT EXPIRED FROM, WHAT IS BELIEVED TO BE, A PERICARDIAL EFFUSION. AFTER REMOVING MATERIAL FROM THE RIGHT SIDE OF THE LUNG AND SWITCHING TO THE LEFT, THE PHYSICIAN LOST ACCESS AND THE CANNULA FELL OUT OF THE LUNGS AND INTO THE RVOT/RV. THE PHYSICIAN TRIED TO REGAIN ENTRY INTO THE MAIN PULMONARY ARTERY BY ADVANCING THE CANNULA. WHEN HE WAS STEERING IN THE HEART, THE FUNNEL DIDN'T HAVE THE FULL BEND OF THE CANNULA PLUS 2 CM. IT WAS BARELY EXPOSED OUT OF THE OUTER SHEATH. THE TM RECOMMENDED THEY REMOVE THE WHOLE SYSTEM AND START OVER WITH THE SWAN OR SOME OTHER DEVICE. THE PHYSICIAN STEERED AROUND FOR JUST A LITTLE AND TOOK A PICTURE WHEN THE PERICARDIAL EFFUSION WAS NOTED. ONCE CONTRAST WAS SHOT INTO THE CANNULA AND THE PERICARDIAL EFFUSION WAS SHOWING, THE PATIENT STARTED DECOMPENSATING. AFTER AN HOUR OF CPR AND EPI ADMINISTERED, THE PATIENT EXPIRED. IT WAS THOUGHT THAT BECAUSE THE CANNULA WAS BARELY EXPOSED OUT OF THE OUTER SHEATH AND THE PHYSICIAN WAS TRYING TO REGAIN ACCESS, THAT THIS MAY HAVE CONTRIBUTED TO THE EVEN

  Patient problems: Pericardial Effusion

  MAUDE report 21179196 ↗
• DeathOct 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ANGGIODYNAMICS SENIOR TERRITORY MANAGER REPORTED A PATIENT DEATH OCCURRED DURING A PROCEDURE WITH AN ALPHAVAC MULTIPURPOSE MECHANICAL ASPIRATOR F18 C85, AS WELL AS AN AMPLATZ WIRE AND GORE DRY SEAL SHEATH; PLACED IN THE GROIN. THE PATIENT WAS, REPORTEDLY, VERY SICK PRIOR TO ATTEMPTING THE PROCEDURE AND MET THE CRITERIA FOR HIGH-RISK DUE TO A MASSIVE PULMONARY EMBOLISM (PE) AND HEART FAILURE. AFTER THE PHYSICIAN CROSSED THE R HEART WITH THE ALPHAVAC OVERSHEATH, THE PATIENT LOST THEIR BLOOD PRESSURE AND PULSE. THE DEVICE WAS IMMEDIATELY REMOVED FROM THE BODY AND THE PATIENT HAD A DNR ORDER; THEREFORE, CPR WAS ATTEMPTED, ONLY VERY BRIEFLY. ULTIMATELY, THE PATIENT EXPIRED. THE PHYSICIAN BELIEVES THAT THERE IS NO CASUAL RELATIONSHIP BETWEEN THE ALPHAVAC DEVICE AND THE PATIENT'S EXPIRATION. PRIOR TO THE PROCEDURE, THE PHYSICIAN HAD INFORMED THE PATIENT THAT SHE MAY NOT SURVIVE THE PROCEDURE DUE TO HER FRAILTY AND R HEART FAILURE. THE PROCEDURE WAS PERFORMED IN ACCORDANCE WITH THE IFU AND THE PHYSICIAN HAS BEEN TRAINED ON THE FLOW MODEL DEMO AND ONE OTHER SUCCESSFUL ALPHAVAC CASE, WITHOUT INCIDENT. THE ANGIODYNAMICS SENIOR TERRITORY MANAGER WAS ALSO PRESENT FOR THIS CASE AND HAS BEEN P

  Patient problems: Cardiac Arrest

  MAUDE report 20464863 ↗
• InjuryAug 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ANGIODYNAMICS SENIOR TERRITORY MANAGER REPORTED THE FOLLOWING EVENT, DURING USE OF AN ALPHAVAC MULTIPURPOSE MECHANICAL ASPIRATOR F18 C85: "DOCTOR (B)(6) WAS UTILIZING ALPHAVAC F18 FOR THE TREATMENT OF A PE. DURING THE CASE THE PATIENTS BLOOD PRESSURE DROPPED AND HEART RATE INCREASED. DOCTOR HAD SUSPICION OF PERFORATION AND CALLED CT SURGERY. UPON DISCUSSION AND IMAGING THEY TOOK PATIENT FOR EMERGENT SURGERY WHERE IT WAS CONFIRMED THERE WAS A PERFORATION IN THE RV OF THE HEART. DOCTOR (B)(6) STATED TO ME AFTER THE SURGERY THAT "I DO NOT BELIEVE THIS WAS DEVICE RELATED". PATIENT MADE IT OUT OF SURGERY AND IS RESPONDING WELL TO THERAPY AS OF TODAY (B)(6) 2024." DOCTOR (B)(6) HAS RECEIVED IN-SERVICE TRAINING TWICE, THE MOST RECENT TIME BEING JUST BEFORE THIS PROCEDURE; HOWEVER, THIS WAS HIS FIRST ALPHAVAC CASE. PREVIOUSLY, HE PERFORMED 2 ANGIOVAC CASES. THE PROCEDURE WAS PERFORMED IN ACCORDANCE WITH THE DIRECTIONS FOR USE (DFU).

  Patient problems: Intraoperative Cardiac Injury; Low Blood Pressure/ Hypotension; Perforation of Vessels; Tachycardia

  MAUDE report 19931963 ↗
• DeathJun 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ANGIODYNAMICS CLINICAL SPECIALIST REPORTED A PATIENT ADVERSE EVENT, OCCURRING 4-5 HOURS AFTER A PROCEDURE WITH AN ALPHAVAC F18-85. THE ALPHAVAC PROCEDURE WAS COMPLETED SUCCESSFULLY; HOWEVER, THE PATIENT EXPIRED 4-5 HOURS AFTER THE PROCEDURE, DUE TO COMPLICATIONS FROM AN UNRELATED CORONARY ANGIOGRAM PROCEDURE 2 DAYS PRIOR, ON (B)(6) 2024. ACCESS FOR THAT PROCEDURE WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY, AND SUBSEQUENTLY, THERE WERE ACCESS COMPLICATIONS/BLEEDING FROM THAT ARTERY INTO THE RETROPERITONEAL SPACE AND SCROTUM. BLEEDING FROM THE ACCESS SITE WAS RESTARTED THE DAY OF THE ALPHAVAC PROCEDURE BECAUSE THE PATIENT WAS GIVEN THROMBOLYTICS WHICH MADE BLEEDING FROM THE ARTERIAL STICK SITE EASIER. PER THE PHYSICIAN, THE PATIENT EXPIRED DUE TO HEMORRHAGIC SHOCK VIA THE FEMORAL ARTERIAL ACCESS SITE AND THEIR EXPIRATION HAD NOTHING TO DO WITH THE ALPHAVAC PROCEDURE OR ANY ANGIODYNAMICS DEVICE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Hypovolemic Shock

  MAUDE report 19499308 ↗
• DeathMay 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ANGIODYNAMICS SALES DIRECTOR REPORTED A PATIENT DEATH, OCCURRING A FEW HOURS AFTER AN ALPHAVAC PROCEDURE, WITH AN ALPHAVAC MULTIPURPOSE MECHANICAL ASPIRATOR F18 C85. THE PROCEDURE WAS PERFORMED IN ALIGNMENT WITH THE DIRECTIONS FOR USE (DFU) AND ALTHOUGH THIS WAS THE PHYSICIAN'S FIRST ALPHAVAC CASE, HE IS AN EXPERIENCED PENUMBRA AND INARI USER. NO ADJUNCT DEVICES WERE UTILIZED DURING THE PROCEDURE. ACCORDING TO THE PHYSICIAN, THE PATIENT WAS IN CRITICAL CONDITION, WITH MULTIPLE PULMONARY EMBOLI, AND THEIR DEATH WAS UNRELATED TO ANY ANGIODYNAMICS DEVICE. IT WAS NOTED; HOWEVER, THAT THE FUNNEL PORTION OF THE DEVICE COLLAPSES EASILY UNDER NEGATIVE PRESSURE.

  Patient problems: Pulmonary Embolism

  MAUDE report 19300730 ↗
• InjuryOct 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ANGIODYNAMICS CLINICAL SPECIALIST REPORTED A PATIENT ADVERSE EVENT, FOLLOWING TREATMENT WITH AN ALPHAVAC MULTIPURPOSE MECHANICAL ASPIRATOR F18 C85. THE FOLLOWING WAS REPORTED: DURING THE TIME I WAS ON FACETIME WITH THEM, ALL SEEMED WELL. WHEN DR. (B)(6) SAID THEY NO LONGER NEEDED MY HELP AND ENDED THE CALL THE PATIENT WAS DOING GREAT. I LATER LEARNED THAT THE PATIENT HAD A DECOMPENSATION AFTER THE CASE WAS COMPLETE AND REQUIRED ICU ADMISSION. A PERICARDIAL EFFUSION WAS DISCOVERED. THE BELOW ARE TEXTS FROM DR. (B)(6)COPIED DIRECTLY WORD FOR WORD. SOUNDS LIKE A TECHNIQUE ISSUE BY A FELLOW THAT WAS SCRUBBED INTO THE CASE. "HE WAS IMPROVED AT THE [?] END' OF THE CASE WHEN I LEFT THE HOSPITAL (I WASN'T SCRUBBED FOR CASE). THEY WERE IN THE PROCESS OF REINFUSING SOME OF THE ASPIRATED BLOOD FROM THE CASE, USING THE HAEMONETICS FILTER, AS SHARED. HE DECOMPENSATED AFTER THE SHEATH WAS REMOVED AND WAS FOUND TO HAVE A SMALL AMOUNT OF PERICARDIAL FLUID SUGGESTING TAMPONADE AS CAUSE OF DECOMPENSATION - PRESUMED IATROGENIC INJURY - TAPPED 20ML OF BLOODY FLUID FROM PERICARDIAL SPACE. I WAS THERE FROM PUNCTURE UNTIL REMOVAL OF THE ALPHAVAC FROM THE SHEATH. I SAW NOTHING DURING THAT TIME WHICH WO

  Patient problems: Cardiac Perforation; Cardiac Tamponade

  MAUDE report 18041483 ↗
• DeathSep 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ANGIODYANMICS' TERRITORY MANAGER REPORTED THAT APPROXIMATELY ONE HOUR INTO A PATIENT PROCEDURE USING THE ALPHAVAC MULTIPURPOSE MECHANICAL ASPIRATOR F18 C85 TO TREAT A PULMONARY EMBOLISM IN THE PULMONARY ARTERY (PA), THE USER-FACILITY'S VASCULAR FELLOW ADVANCED THE DILATOR THROUGH THE SHEATH TO DELIVER CONTRAST AND IS SUSPECTED TO HAVE PERFORATED THE PA AND OR RIGHT HEART. STERNOTOMY WAS PERFORMED BUT ULTIMATELY THE PATIENT EXPIRED DUE TO CARDIAC TAMPONADE. THE DECISION WAS MADE NOT TO PUT THE PATIENT ON ECMO DUE TO METASTATIC CANCER DIAGNOSIS. IT WAS REPORTED THAT THE USER FACILITY'S SURGEON DID NOT FOLLOW THE ADVICE/SUGGESTION TO INSERT THE PIGTAIL THROUGH THE TOUHY AND USED THEIR OWN METHOD FOR SHOOTING CONTRAST FOR A PICTURE RESULTING IN PATIENT HARM (PUNCTURING PA AND OR RIGHT HEART).

  Patient problems: Cardiac Arrest; Infiltration into Tissue

  MAUDE report 17692552 ↗
• MalfunctionFeb 7, 2023Material Twisted/Bent; Device Handling Problem; Material Twisted/Bent; Device Handling Problem

  AN END USER EXPERIENCED AN ISSUE WHEN USING AN ALPHAVAC MULTIPURPOSE MECHANICAL ASPIRATOR F18 C8. DURING THE PROCEDURE, THE CANNULA KINKED TO AN UNUSABLE STATE TRYING TO ADVANCE THRU THE HEMOSTATIC VALVE ON THE SHEATH. AFTER REMOVING THE FUNNEL FROM THE VALVE, IT WOULD NOT HOLD HEMOSTASIS ANYMORE AND BLOOD BEGAN TO LEAK FROM THE PULMONARY ARTERIES AT A HIGH AMOUNT FROM THE PATIENT. THE AMOUNT OF BLOOD LOSS WAS ESTIMATED TO BE APPROXIMATELY 30-40CC'S. NO MEDICAL TREATMENT WAS PROVIDED TO ADDRESS THE BLOOD LOSS. THE PROCEDURE WAS COMPLETED WITH A SECOND ALPHAVAC F18. IT WAS REPORTED THE PATIENT WAS DISCHARGED THE FOLLOWING DAY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16311880 ↗
• DeathNov 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS MEDWATCH IS NOT TO REPORT A DEVICE MALFUNCTION, BUT TO REPORT A PATIENT DEATH DURING A PROCEDURE IN WHICH AN ANGIODYNAMICS' PRODUCT WAS USED. AN ANGIODYNAMICS TERRITORY MANAGER REPORTED THAT A PATIENT EXPIRED DURING A PROCEDURE, WHILE AN ALPHAVAC MULTIPURPOSE MECHANICAL ASPIRATOR F18 C85 WAS IN USE. PROCEDURE NOTES PROVIDED BY THE TM REPORTED THE FOLLOWING: THE ALPHAVAC F18 SYSTEM WAS PLACED IN THE RFV THROUGH A 22F GORE SHEATH. WITH THE ALPHAVAC SHEATH TIP JUST BEYOND PV, THE FUNNEL WAS ADVANCED INTO THE RPA AND THE HANDLE WAS PULLED AT 30 CC SETTING APPROX 4 TIMES. THE WASTE BAG WAS REMOVED FROM SYSTEM, AND NOTED IT CONTAINED APPROX 150 ML OF BLOOD AND A STRAND OF CLOT. TO REDIRECT INTO LPA, THE ALPHAVAC CANNULA WAS REMOVED FROM THE ALPHAVAC SHEATH, AND A CATHETER WAS PLACED THROUGH THE SHEATH OVER A WIRE. (THE CATHETER WAS NOT PLACED THROUGH THE TUOHY PORT BECAUSE A LONG ENOUGH CATHETER WAS NOT AVAILABLE.). UPON ATTEMPTING TO REDIRECT WITH THE CATHETER INTO LPA, THE PATIENT CODED. THE ALPHAVAC SYSTEM WAS REMOVED, AND TPA WAS ADMINISTERED, AND CHEST COMPRESSIONS WERE INITIATED. ADDITIONAL EVENT INFORMATION PROVIDED NOTED THE FOLLOWING: THE ANGIOGRAPHIC CATHETER AND WIRE TYPE

  Patient problems: Cardiac Arrest

  MAUDE report 15734507 ↗
• InjuryOct 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS MEDWATCH IS NOT TO REPORT A DEVICE MALFUNCTION, BUT TO REPORT AN ADVERSE PATIENT EFFECT DURING A PROCEDURE IN WHICH ANGIODYNAMICS' PRODUCT WAS USED. AN ANGIODYNAMICS CLINICAL SERVICES MANAGER REPORTED A PATIENT ISSUE, DURING TREATMENT WITH AN ALPHAVAC MULTIPURPOSE MECHANICAL ASPIRATOR F18 C85. THE FOLLOWING WAS REPORTED: "23 FEMALE WITH BILATERAL PULMONARY EMBOLISMS. DESCRIBED BY PHYSICIAN AS VERY SICK AND WITH CO-MORBIDITIES INCLUDING OBESITY AND ENLARGED HEART. INTUBATED FOR PROCEDURE UNDER GENERAL ANESTHESIA. WIRE AND CATHETER ADVANCED TO PA FROM RFV ACCESS SITE. PA PRESSURE MEASUREMENT OF 39MMHG OBTAINED. PULMONARY ARTERIOGRAM OF RPA OBTAINED THAT DEMONSTRATED DISTAL MATERIAL AT THE SEGMENTAL BIFURCATION. GORE 22FR ACCESS TO RFV. F1885 ALPHA CHOSEN. GLIDE WIRE TO RPA, EXCHANGED FOR AMPLATZ SS 1CM FLOPPY TIP. 1ST ATTEMPT TO ADVANCE ALPHA SHEATH UNSUCCESSFUL. CARDIAC SILHOUETTE GREATER THAN HALF THE CHEST WIDTH. ANGLE FROM TV TO RVOT IS CHALLENGING / SEVERE. WIRE RE-ADVANCED TO RPA AND SHEATH ABLE TO BE ADVANCED ON SECOND ATTEMPT. TIP OF SHEATH PARKED IN DISTAL RPA NEAR THE SEGMENTAL BIFURCATION. CANNULA FLUSHED AND ADVANCED TO TIP OF SHEATH, SHEATH THEN PULLED BACK TO EXPOS

  Patient problems: Cardiac Arrest

  MAUDE report 15638255 ↗
• InjuryMay 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS MEDWATCH IS NOT TO REPORT A DEVICE MALFUNCTION, BUT TO REPORT AN ADVERSE PATIENT EFFECT POST PROCEDURE. AN ANGIODYNAMICS TERRITORY MANAGER (TM) REPORTED VIA A PRODUCT EVALUATION SURVEY, A PATIENT ADVERSE EVENT OCCURRED AFTER TREATMENT WITH AN ALPHAVAC MULTIPURPOSE MECHANICAL ASPIRATION F18-85 CANNULA. THE PATIENT WAS TREATED FOR A LEFT ATRIAL THROMBUS, REMOVING APPROXIMATELY 95% OF THE THROMBOEMBOLI, AND NO ISSUES WERE NOTED DURING THE PROCEDURE. HOWEVER, APPROXIMATELY 2-3 HOURS AFTER THE PROCEDURE WAS COMPLETED, THE PATIENT SUFFERED A STROKE. AT THIS TIME THE PATIENT IS CURRENTLY STABLE AND IMPROVING. FOLLOW UP WITH THE TM DETERMINED THAT THE PHYSICIAN CONFIRMED THIS WAS NOT, IN ANYWAY, A RESULT OF PRODUCT MALFUNCTION BUT A COMPLICATION OF THE PROCEDURE.

  Patient problems: Stroke/CVA

  MAUDE report 14454360 ↗