AngioJet™ Solent™ Omni 109681-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 08714729889663), received between Aug 9, 2018 and Jan 29, 2026 — classified as 2 deaths, 2 injuries, 53 malfunctions.

The most frequently reported specific device problem is “Break” (16 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 57 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 29, 2026Fluid/Blood Leak; Deformation Due to Compressive Stress; Difficult to Advance; Suction Failure

  IT WAS REPORTED LOSS OF ASPIRATION OCCURRED. AN ANGIOJET SOLENT OMNI CATHETER WAS SELECTED FOR A FISTULA THROMBECTOMY PROCEDURE. DURING LOADING THE CATHETER OVER THE WIRE, A BEND/KINK WAS NOTED IN THE MIDDLE OF THE CATHETER, AND THE WIRE WAS DIFFICULT TO ADVANCE. A MICRO LEAK OF THE SALINE COMING FROM THE AREA OF THE KINK, AND A LOSS OF ASPIRATION WAS NOTED. THE CATHETER WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24214428 ↗
• DeathNov 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DIED. THE PATIENT PRESENTED WITH UNCONTROLLED HYPERTENSION AND AN ARTERIAL CLOT IN A RECENTLY PLACED STENT. AN ANGIOJET SOLENT OMNI WAS SELECTED FOR USE. DURING THIS PROCEDURE, THE PATIENT BEGAN EXPERIENCING CHEST PAIN, HOWEVER, NO BRADYCARDIA WAS OBSERVED. SUBLINGUAL NITROGLYCERIN WAS ADMINISTERED TO TREAT THE CHEST PAIN. FOLLOWING THIS, THE PATIENT WAS TRANSFERRED TO THE CATHETER LAB FOR CORONARY STENT PLACEMENT AND THEN MOVED TO THE INTENSIVE CARE UNIT (ICU) FOR FURTHER MONITORING. POST-PROCEDURE, THE PATIENT DEVELOPED PANCREATITIS AS A COMPLICATION AND THE PATIENT DIED. THE PATIENT'S COMORBIDITY WAS HYPERTENSION. IT WAS FURTHER REPORTED THE ANGIOJET DEVICE FUNCTIONED AS INTENDED. A 10MG TPA (ALTEPLASE) & 500ML NACL 0.9% WITH 2,500 UNIT HEPARIN ADDED AND GIVEN THROUGH THE ANGIOJET, ALSO THE PATIENT WAS HYDRATED BEFORE/DURING/AFTER THE PROCEDURE. OCCLUSION OF THE STENTS LIKELY SECONDARY TO EXTRINSIC COMPRESSION OF THE RIGHT COMMON ILIAC STENT PROXIMALLY. THE ANGIOJET RUN TIME WAS 60-65 SECONDS AND DWELL TIME WAS 23-30 MIN. DURING 20-30-MINUTE WAIT TIME, PATIENT DEVELOPED SIGNIFICANT HYPERTENSION AND HAD AN EPISODE OF CHEST PAIN. THE PATIENT WAS TR

  Patient problems: Abdominal Pain; Chest Pain; Pancreatitis

  MAUDE report 23598080 ↗
• DeathJun 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LOCATIONIT WAS REPORTED THAT THE PATIENT DIED. THE TARGET LESION WAS LOCATED IN THE POPLITEAL ARTERY. THE PROCEDURE WENT WELL, HOWEVER, THE DOCTOR NOTED THAT THE PATIENT MIGHT DEVELOP COMPARTMENT SYNDROME. POST-PROCEDURE, THE PATIENT EXHIBITED SOME UNKNOWN COMORBIDITIES. NO COMPLICATIONS RELATED TO THE DEVICE, OR THE PROCEDURE WERE NOTED; HOWEVER, THE PATIENT SUBSEQUENTLY DECEASED. IT WAS FURTHER REPORTED THAT THE PROCEDURE TOOK PLACE IN THE MID TO LATE AFTERNOON. THE ANGIOJET WAS USED IN THE POPLITEAL ARTERY WHICH WAS COMPLETELY OCCLUDED ALL THE WAY DOWN. THERE WERE NO ISSUES WITH THE ANGIOJET CATHETER. DUE TO THE PATIENT'S LEG BEING COLD FOR A LONG PERIOD OF TIME (DUE TO THE OCCLUSION/LACK OF BLOOD FLOW), IT WOULD HAVE BEEN IDEAL TO GRADUALLY INTRODUCE BLOOD FLOW BACK TO THE ARTERY. HOWEVER, IT WAS NOTED THAT THE ANGIOJET WAS ABLE TO OPEN THE VESSEL VERY QUICKLY WHICH IS WHY IT WAS THOUGHT THAT THE PATIENT MAY EXPERIENCE COMPARTMENT SYNDROME. DURING RECOVERY, THE PATIENTS LEG BEGAN SWELLING. THE PATIENT WAS TAKEN STRAIGHT TO THE OPERATING ROOM, AND A UNILATERAL FASCIOTOMY WAS PERFORMED. POST-PROCEDURE, THE PATIENT SHOWED SIGNS OF SHOCK, WITH ABNORMAL LAB RESULTS. THE PATIENT'S CO

  Patient problems: Ischemia; No Clinical Signs, Symptoms or Conditions; Septic Shock

  MAUDE report 22161532 ↗
• MalfunctionMar 27, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CATHETER BREAK OCCURRED. AN ANGIOJET SOLENT OMNI WAS SELECTED FOR USE IN A THROMBECTOMY PROCEDURE. DURING WITHDRAWAL, IT WAS NOTED THAT A CATHETER BREAK OCCURRED. THE PROCEDURE WAS COMPLETED USING THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21710123 ↗
• MalfunctionSep 26, 2024Break; Difficult to Advance; Material Deformation; Adverse Event Without Identified Device or Use Problem; Break; Difficult to Advance; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CATHETER BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS RIGHT SUPERFICIAL FEMORAL ARTERY. A SOLENT OMNI CATHETER WAS SELECTED FOR A THROMBECTOMY PROCEDURE. DURING THE PROCEDURE, THE CATHETER WAS DIFFICULT TO TRACK. CONSEQUENTLY, THE CATHETER BECAME KINKED AFTER A FEW PASSES AND APPEARED TO HAVE A BREAK IN THE MIDDLE SHAFT OF HYPOTUBE. THE DEVICE WAS REMOVED FROM THE PATIENT INTACT. THE PROCEDURE WAS COMPLETED WITH A SOLENT PROXI CATHETER DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20315664 ↗
• MalfunctionJun 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 31MAY2024. IT WAS REPORTED THAT FLUID FLOW BACK OCCURRED. THE PATIENT UNDERWENT AORTOGRAM WITH THROMBECTOMY OF THE TARGET LESION LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. AN ANGIOJET DEVICE WAS USED IN THE PATIENT; HOWEVER, DURING POWER PULSE MODE, BLOOD WAS BEING SUCKED INTO THE OUTFLOW BAG INSTEAD OF SPRAYING THE CLOT WITH LYTIC. IT WAS CONFIRMED THAT THE CONSOLE WAS IN POWER PULSE MODE DURING THE EVENT. THE PHYSICIAN WAS UNABLE TO USE POWER PULSE MODE BUT WAS ABLE TO USE THE THROMBECTOMY MODE TO GET CLOT OUT OF THE BODY AS ASPIRATION WAS NOT LOST. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A DETACHED/SEPARATED HYPOTUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19598142 ↗
• MalfunctionMay 7, 2024Break; Break

  IT WAS REPORTED THAT CATHETER FRACTURE OCCURRED. AN ANGIOJET SOLENT OMNI WAS USED FOR THROMBECTOMY PROCEDURE. THE TREATMENT AREA WAS LOCATED IN A FEMORAL-FEMORAL POPLITEAL GRAFT. POWERPULSE WAS INITIATED FOR 180 SECONDS. AFTER 180 SECONDS. A VISIBLE MIST WAS OBSERVED COMING FROM CATHETER SHAFT WHICH HAD FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19261426 ↗
• MalfunctionFeb 19, 2024Break; Break

  IT WAS REPORTED THAT THE CATHETER BROKE. THE TARGET LESION WAS LOCATED IN AN ARTERIOVENOUS FISTULA. AN ANGIOJET SOLENT OMNI CATHETER WAS PREPPED, MADE 1 PASS IN THE THROMBECTOMY MODE, AND DURING THE SECOND PASS, A LEAKAGE WAS NOTED MID-SHAFT OF THE CATHETER. AFTER REMOVAL, THE CATHETER WAS INSPECTED AND A SMALL CRACK OR HOLE IN THE MID-SHAFT WAS NOTED CAUSING THE LEAK. NO DETACHMENT WAS NOTED ON THE CATHETER AND THE DEVICE WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18731453 ↗
• MalfunctionJan 25, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT HYPOTUBE BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. AN ANGIOJET SOLENT OMNI WAS USED FOR THROMBECTOMY PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE CATHETER HAVE A DISTINCT BEND AND SEPARATED IN THE INSIDE OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18584207 ↗
• MalfunctionDec 19, 2023Break; Break

  IT WAS REPORTED THAT MID SHAFT FRACTURED OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. AN ANGIOJET SOLENT OMNI WAS USED FOR THROMBECTOMY PROCEDURE. DURING THE PROCEDURE, A SPILT IN THE FLUID DELIVERY LINE AND CLEAR PLASTIC OUTER LINER WAS NOTED. MOREOVER, IT WAS NOTED THAT THE MID SHAFT WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18357545 ↗
• MalfunctionDec 19, 2023Fracture; Material Deformation; Adverse Event Without Identified Device or Use Problem; Fracture; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND NON-CALCIFIED FEMORAL GRAFT AND SUPERFICIAL FEMORAL ARTERY. AN ANGIOJET SOLENT OMNI CATHETER WAS USED FOR THROMBECTOMY PROCEDURE. WHILE ADVANCING TO THE TARGET LOCATION, THE DEVICE WAS REQUIRED TO MAKE TWO 90 DEGREE TURNS. DURING POWER PULSE MODE, THROMBOLYTICS WERE INFUSED INTO THE OCCLUDED LESION. HOWEVER, THE DEVICE DEVELOPED A KINK AND FRACTURE IN THE DELIVERY SHAFT WHERE THE COILED SILVER SECTION MEETS THE PURPLE PLASTIC SEGMENT, NEAR THE TIP. THE DEVICE WAS REMOVED INTACT, AND THE PROCEDURE WAS COMPLETED BY REPLACING THE CATHETER. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18356395 ↗
• MalfunctionOct 19, 2023Difficult to Advance; Material Integrity Problem; Difficult to Advance; Material Integrity Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 29-SEP-2023. IT WAS REPORTED THAT LUER LOCK NUT WAS DAMAGE. AN ANGIOJET SOLENT OMNI WAS SELECTED FOR USE FOR THROMBECTOMY PROCEDURE. DURING PROCEDURE, IT WAS OBSERVED THAT THE BACK WIRE CLIP ON THE CATHETER WAS MALFUNCTIONING. HOWEVER, IT WAS FURTHER REPORTED THAT THE PHYSICIAN EXPERIENCED DIFFICULTY TRACKING OVER THE WIRE, AS IT FAILED TO EXIT THE CATHETER WHEN PRESSURE WAS APPLIED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A BROKEN HYPOTUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17967256 ↗
• MalfunctionOct 13, 2023Break; Leak/Splash; Material Deformation; Break; Leak/Splash; Material Deformation

  IT WAS REPORTED THAT CATHETER BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE 85% STENOSED TARGET LESION LOCATED IN THE PROXIMAL SUPERFICIAL FEMORAL ARTERY AND DISTAL SUPERFICIAL FEMORAL ARTERY, POPLITEAL ARTERY. AN ANGIOJET SOLENT OMNI WAS SELECTED FOR USE FOR THROMBECTOMY PROCEDURE. FIRST, THE MD INTRODUCED A 7FR 45CM DESTINATION SHEATH UP AND ACROSS THE BIFURCATION DURING THE PROCEDURE, AND A GORE VIABAHN STENT WAS PLACED OVER THE CLOTTED AREA AND POST-DILATED WITH A STERLING BALLOON. THE PHYSICIAN THEN CHOSE THE ANGIOJET SOLENT OMNI CATHETER IN POWER PULSE MODE AFTER THE POST-ANGIOGRAM REVEALED INCREASED CLOT DEVELOPMENT DISTALLY. AFTER DRAWING BACK ON THE DEVICE, THE PHYSICIAN OBSERVED HOLES IN THE ANGIOJET SOLENT OMNI CATHETER, WITH TPA COMING OUT OF THE CATHETER'S SIDE IN THREE DISTINCT LOCATIONS. THE BROKEN CATHETER WAS EXAMINED AND DISCOVERED TO HAVE MANY FRACTURES AS WELL AS A 'FLATTENED CATHETER' AREA IN THE SHAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17930696 ↗
• MalfunctionAug 22, 2023Entrapment of Device; Material Deformation; Entrapment of Device; Material Deformation

  IT WAS REPORTED THAT CATHETER STUCK ON WIRE. THE TARGET LESION WAS LOCATED AT THE LEFT DISTAL SUPERIOR FEMORAL ARTERY (SFA). AN ANGIOJET SOLENT DISTA CATHETER WAS ADVANCED FOR THROMBECTOMY PROCEDURE. DURING THE PROCEDURE, THE CATHETER BECAME ENTRAPPED ON A NON-BSC GUIDEWIRE. THE CATHETER WAS UNABLE TO BE REMOVED SO THE PATIENT WAS TRANSFERRED FROM THE VASCULAR LAB TO A DIFFERENT ROOM TO PERFORM A POSSIBLE CUTDOWN OF BILATERAL GROINS. HOWEVER, THE PHYSICIAN WAS ULTIMATELY ABLE TO PERFORM A CONTROLLED REMOVAL OF THE GUIDEWIRE, CATHETER AND SHEATH UNDER GENERAL ANESTHESIA WITHOUT A CUTDOWN. IT WAS REMOVED UNDER FLUOROSCOPIC GUIDANCE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17596365 ↗
• MalfunctionApr 7, 2023Break; Break

  IT WAS REPORTED THAT CATHETER BREAK OCCURRED. AN ANGIOJET SOLENT OMNI WAS USED FOR THROMBECTOMY PROCEDURE. HOWEVER, DURING PREPARATION, A FRACTURE IN THE CATHETER SHAFT WAS NOTICED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16702443 ↗
• MalfunctionAug 17, 2022Display or Visual Feedback Problem; Suction Problem; Display or Visual Feedback Problem; Suction Problem

  IT WAS REPORTED THAT LOSS OF ASPIRATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY AND COMMON ILIAC ARTERY. AN ANGIOJET SOLENT OMNI CATHETER WAS USED FOR THROMBECTOMY PROCEDURE. THE CATHETER WORKED FOR 207 SECONDS OF RUN TIME AND WAS REMOVED TWICE DURING THE CASE TO ALLOW FOR INTRAVASCULAR ULTRASOUND. UPON RE-INSERTION, WHILE IN THROMBECTOMY MODE, THE CONSOLE DISPLAYED AN ERROR FOR SALINE NOT CORRECTLY INFUSING. THE ERROR DID NOT RESOLVE WITH TROUBLESHOOTING AND WAS THEREFORE REMOVED. THEY ATTEMPTED TO RE-PRIME, BUT THE ERROR STILL OCCURRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15246611 ↗
• MalfunctionJul 14, 2022Suction Problem; Suction Problem

  IT WAS REPORTED THAT THERE WAS A LOSS OF ASPIRATION. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). AN ANGIOJET SOLENT OMNI WAS SELECTED FOR THROMBECTOMY PROCEDURE. DURING PROCEDURE, IT WAS NOTED THAT THERE WAS A SUCTION ISSUE AND THE DEVICE DID CONTINUE TO PUMP. THE PROCEDURE WAS COMPLETED WITH ANOTHER ANGIOJET DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15014684 ↗
• MalfunctionJul 6, 2022Entrapment of Device; Difficult to Advance; Entrapment of Device; Difficult to Advance

  IT WAS REPORTED THAT GUIDEWIRE STUCK OCCURRED. AN ANGIOJET SOLENT OMNI WAS USED DURING THE THROMBECTOMY PROCEDURE. A NON-BOSTON SCIENTIFIC FILTER WIRE WAS ADVANCED BUT IT WAS UNABLE TO PROGRESS THE CATHETER AS IT BECAME STUCK ON THE WIRE. THE PHYSICIAN HAD TO TAKE OUT THE WHOLE SYSTEM. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14939945 ↗
• MalfunctionFeb 3, 2022Leak/Splash; Device Difficult to Setup or Prepare; Leak/Splash; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. AN ANGIOJET SOLENT OMNI CATHETER WAS USED IN A THROMBECTOMY PROCEDURE. PRIOR TO THE PROCEDURE, IT WAS NOTED THAT DURING PRIMING, SALINE WAS LEAKING FROM THE PUMP BULB. THE DEVICE WAS RESET BUT STILL COULD NOT PRIME. THE PROCEDURE WAS THEN CANCELLED AND RESCHEDULED FOR THE FOLLOWING DAY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13442581 ↗
• MalfunctionDec 15, 2021Fluid/Blood Leak; Material Puncture/Hole

  ANGIOJET EQUIPMENT PRIMED BY RN PRIOR TO USE OF ANGIOJET. WHEN CASSETTE PLACED IN MACHINE AND DOOR CLOSED TO LOAD THE CASSETTE, MACHINE DID NOT RECOGNIZE CASSETTE. DOOR REOPENED AND CASSETTE RESEATED. DOOR CLOSED AND MACHINE STILL DID NOT RECOGNIZE CASSETTE IN ORDER TO CONTINUE WITH PRIMING. DOOR REOPENED AND WHEN CASSETTE WAS VISUALLY EXAMINED, RN NOTED THAT SOMETHING APPEARED DIFFERENT AND, UPON CLOSER EXAMINATION OF "BALLOON" AT TOP OF METAL PLUNGER, A FLUID LEAK WAS NOTED AND SMALL PUNCTURE WAS VISIBLE. ENTIRE ANGIOJET ASSEMBLY WAS IMMEDIATELY REMOVED FROM FIELD AND MACHINE; REPLACED WITH NEW ANGIOJET PRODUCT WHICH THEN IMMEDIATELY WORKED, PRIMING CORRECTLY AND NO FURTHER DIFFICULTIES WERE ENCOUNTERED FOR THE REST OF THE CASE. DEFECTIVE PRODUCT WAS NEVER LOADED ONTO GUIDEWIRE OR INSERTED INTO PATIENT PRIOR TO REMOVAL. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13019456 ↗
• MalfunctionNov 7, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. AN ANGIOJET SOLENT OMNI WAS USED IN A THROMBECTOMY PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE WAS UNRAVELED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12760242 ↗
• MalfunctionNov 3, 2021Suction Problem; Material Perforation; Suction Problem; Material Perforation

  IT WAS REPORTED THAT LOSS OF ASPIRATION OCCURRED. AN ANGIOJET SOLENT OMNI CATHETER WAS USED FOR THE THROMBECTOMY PROCEDURE. DURING THE PROCEDURE, IT WAS REPORTED THERE WAS A HOLE IN THE SHAFT OF THE CATHETER CAUSING DIMINISHED SUCTION POWER. THE DEVICE CONTINUED TO PUMP SALINE WHEN ASPIRATION WAS LOST AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12744996 ↗
• MalfunctionSep 2, 2021Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT STERILTY WAS COMPROMISED. AN ANGIOJET SOLENT OMNI CATHETER WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THE STERILE PACKAGE WAS ALREADY OPENED. THE PRODUCT WAS NOT SENT TO THE STERILE FIELD. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12413648 ↗
• MalfunctionMay 14, 2021Suction Problem; Suction Problem

  IT WAS REPORTED THAT LOSS OF ASPIRATION OCCURRED. AN ANGIOJET SOLENT OMNI CATHETER WAS USED IN A THROMBECTOMY PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE CATHETER WOULD NOT PERFORM THROMBECTOMY AND ASPIRATION WAS LOST WHILE THE DEVICE CONTINUE TO PUMP SALINE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11829328 ↗
• MalfunctionMar 17, 2021Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT CATHETER BREAK OCCURRED. AN ANGIOJET SOLENT OMNI CATHETER WAS USED FOR TREATMENT. DURING THE PROCEDURE WHILE IN THROMBECTOMY MODE, THE CATHETER WAS KINKED AND APPEARED THAT THE METAL COILS INSIDE THE SHAFT HAD COME APART. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11505400 ↗