Ellipsys Vascular Access System AMI6005 (REF AMI6005 US)Recalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 00763000496975), received between Nov 19, 2021 and Nov 11, 2025 — classified as 46 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (7 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 53 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 11, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A SHIPMENT OF A DEMO (NOT FOR HUMAN USE) ELLIPSYS CATHETER WAS INCLUDED IN A STERILE, FOR-HUMAN-USE REVENUE ORDER. THE ISSUE WAS IDENTIFIED DURING UNPACKING OF THE BOX RECEIVED, PRIOR TO ANY PATIENT USE. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23520761 ↗
• MalfunctionOct 29, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE ELLIPSYS CATHETER, THE DEVICE TIP WAS OBSERVED TO BE ROTATED 45 DEGREES UPON REMOVAL AND THE DEVICE GAP REMAINED AT 4.5 MILLIMETERS WHEN THE BUTTON WAS PRESSED TO CLAMP DOWN. NO FISTULA WAS CREATED. THE EVENT OCCURRED IN THE PROXIMAL RADIAL ARTERY. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. THE PROCEDURE WAS ABORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23416180 ↗
• InjuryMay 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE AN ELLIPSYS DEVICE WAS USED TO TREAT THE RIGHT ARM ARTERIOVENOUS FISTULA. APPROXIMATELY 2 MONTHS POST PROCEDURE PATIENT SUFFERED NONOCCLUSIVE THROMBUS IN THE LOWER ARM CEPHALIC VEIN OF RIGHT ARM. SUBJECT HAD PREVIOUSLY OMITTED PREVIOUS SECONDARY PROCEDURE DURING INTERROGATION AT VISIT 3 AND 6, DUPLEX ULTRASOUND COMPLETED DURING VISIT 12 SUGGESTING PRIOR INTERVENTIONS. MEDICAL RECORDS WERE REQUESTED AND SHOWED A SECONDARY PROCEDURE DUE TO A WRITTEN REFERRAL FOR DIFFICULT CANNULATION, WHERE A FISTULAGRAM WAS COMPLETED SHOWING STENOSIS OF THE MID ARM CEPHALIC VEIN AND A NONOCCLUSIVE THROMBUS WAS NOTED IN THE LOWER ARM CEPHALIC VEIN. STENOSIS AND THROMBUS WERE ADDRESSED BY SECONDARY PROCEDURE ON COMPLETED WITH RESOLUTION WITH REMOVAL OF CENTRAL VENOUS CATHETER. PATIENT RECOVERED.

  Patient problems: Stenosis; Thrombosis/Thrombus

  MAUDE report 22000720 ↗
• InjuryApr 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE AN ELLIPSYS CATHETER WAS USED TO TREAT THE RIGHT ARM. AN INPACT ADMIRAL BALLOON WAS LATER USED TO TREAT THE ANASTOMOSIS. APPROXIMATELY 12 MONTHS POST PROCEDURE PATIENT SUFFERED INFLOW STENOSIS OF BRACHIAL ARTERY OF RIGHT ARM. PHYSICAL EXAM AT 12 MONTH FOLLOW-UP VISIT REVEALED PULSATILITY AND INFLOW STENOSIS WAS NOTED IN DUPLEX ULTRASOUND. SUBJECT WAS REFERRED FOR A FISTULAGRAM AND ANGIOPLASTY AFTER STUDY COMPLETION. AT STUDY COMPLETION THIS ADVERSE EVENT WAS CONSIDERED ONGOING. PATIENT NOT RECOVERED.

  Patient problems: Stenosis

  MAUDE report 21864526 ↗
• InjuryMar 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE AN ELLIPSYS DEVICE WAS USED TO TREAT THE LEFT ARM. APPROXIMATELY 10 MONTHS POST PROCEDURE PATIENT SUFFERED STENOSIS OF JUXTA ANASTOMOTIC SEGMENT OF LEFT ARM. SUBJECT WAS REFERRED BY NEPHROLOGIST DUE TO DIFFICULT CANNULATION, FISTULA GRAM REVEALED 70% STENOSIS OF JUXTA ANASTOMOTIC SEGMENT, AND ANGIOPLASTY WAS PREFORMED RESULTING IN NO RESIDUE STENOSIS. PATIENT HAS RECOVERED.

  Patient problems: Stenosis

  MAUDE report 21686209 ↗
• InjuryMar 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE AN ELLIPSYS WAS USED TO TREAT THE LEFT ARM. APPROXIMATELY 8 MONTHS POST PROCEDURE PATIENT SUFFERED STENOSIS OF MID ARM CEPHALIC VEIN OF LEFT ARM. AT VISIT 12, PATIENT MENTIONED HISTORY OF ADDITIONAL PROCEDURE TO STUDY FISTULA. MEDICAL RECORDS SHOWED A REFERRAL FOR DIFFICULT CANNULATION. A FISTULOGRAM WAS PREFORMED SHOWING A 50% STENOSIS OF THE MID ARM CEPHALIC VEIN OF THE LEFT ARM. STENOSIS WAS TREATED WITH FLUENCY STENT AND ANGIOPLASTY, WITH NO RESIDUAL STENOSIS AFTERWARDS. PATIENT RECOVERED.

  Patient problems: Stenosis

  MAUDE report 21663078 ↗
• InjuryMar 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE AN ELLIPSYS DEVICE WAS USED TO TREAT THE RIGHT ARM. APPROXIMATELY 17 MONTHS LATER THE PATIENT SUFFERED STENOSIS OF RIGHT ARM PERFORATOR. 6 MONTHS DUPLEX ULTRASOUND SHOWED STENOSIS AT THE PERFORATOR VEIN. THE SUBJECT WAS REFERRED FOR A FISTULA GRAM THAT SHOWED A 70-80% STENOSIS AT THE PERFORATOR VEIN. PERFORATOR VEIN WAS TREATED WITH ANGIOPLASTY WITH IMPROVED FLOWS. STENOSIS WAS CONSIDERED RESOLVED. POST-INTERVENTION BRACHIAL ARTERY INFLOW RATE WAS 6199 ML/MIN.

  Patient problems: Stenosis

  MAUDE report 21662025 ↗
• InjuryMar 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE AN ELLIPSYS DEVICE WAS USED TO TREAT THE RIGHT ARM. APPROXIMATELY 2 MONTHS POST PROCEDURE PATIENT SUFFERED DIFFICULT CANNULATION OF RIGHT ELLIPSYS ENDOVASCULAR FISTULA. SUBJECT HAD OMITTED PREVIOUS SECONDARY PROCEDURE DURING INTERROGATION AT VISIT 3 AND 6, PER DUPLEX ULTRASONOGRAPHY COMPLETED DURING VISIT 12 SUGGESTING PRIOR INTERVENTIONS. MEDICAL RECORDS WERE REQUESTED AND SHOWED A SECONDARY PROCEDURE DUE TO A WRITTEN REFERRAL FOR DIFFICULT CANNULATION, WHERE A FISTULA GRAM COMPLETED SHOWING STENOSIS OF THE MID ARM CEPHALIC VEIN AND A NONOCCLUSIVE THROMBUS WAS NOTED IN THE LOWER ARM CEPHALIC VEIN. STENOSIS AND THROMBUS WERE ADDRESSED BY SECONDARY PROCEDURE WITH RESOLUTION AND REMOVAL OF CENTRAL VENOUS CATHETER. PATIENT HAS RECOVERED.

  Patient problems: Stenosis; Thrombosis/Thrombus

  MAUDE report 21661892 ↗
• InjuryDec 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE AN ELLIPSYS CATHETER WAS USED TO TREAT THE LEFT ARM. APPROXIMATELY 6 MONTHS POST PROCEDURE PATIENT SUFFER ED STENOSIS OF UPPER BASILIC VEIN OF LEFT ARM. RECORDS OBTAINED ON SECONDARY PROCEDURE #4 INDICATE 90% STENOSIS IN UPPER ARM BASILIC VEIN OF LEFT ARM BY FISTULAGRAM. ANGIOPLASTY RESOLVES STENOSIS WITH A POST-INTERVENTION STENOSIS OF LESS THAN 10% AND A POST-PROCEDURE BRACHIAL INFLOW OF 1526 ML/MIN. PATIENT RECOVERED.

  Patient problems: Stenosis

  MAUDE report 20908891 ↗
• InjuryNov 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE AN ELLIPSYS CATHETER WAS USED TO TREAT THE LEFT ARM. APPROXIMATELY 2 MONTHS POST PROCEDURE PATIENT SUFFERED THROMBUS IN UPPER ARM CEPHALIC VEIN. AT SECONDARY PROCEDURE FISTULOGRAM, THROMBUS IS NOTED IN UPPER ARM CEPHALIC VEIN. SHARP NEED RE-CANNULATION UNDER DIRECT ULTRASOUND GUIDANCE WITH A MICRO PUNCTURE NEEDLE WAS COMPLETED AND SUBSEQUENTLY CEPHALIC VEIN THROMBUS WAS REMOVED WITH SUCTION CATHETER. UPON FOLLOW UP ASSESSMENT, A FISTULOGRAM IS REPEATED SHOWING OCCLUSION OF THE CEPHALIC VEIN. ASP IRATION TECHNIQUE AND BALLOON MACERATION WAS USED TO DEBULK CLOT, RESOLVING THROMBUS IN CEPHALIC ARM. PATIENT RECOVERED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 20805656 ↗
• MalfunctionNov 18, 2024Electrical /Electronic Property Problem; Mechanical Jam; Electrical /Electronic Property Problem; Mechanical Jam

  PHYSICIAN ATTEMPTED TO USE AN ELLIPSYS CATHETER AND POWER CONTROLLER WITH A 6FR SHEATH AND A 014 NITREX WIRE FOR TREATMENT OF THE PATIENTS PROXIMAL MEDIAN CUBITAL VEIN TO PROXIMAL RADIAL ARTERY IN ARM. A 5X20X90 NON-MEDTRONIC BALLOON WAS USED FOR POST CREATION DILATION, USING A SYRINGE TO EXPAND IT. EMBOLIC PROTECTION WAS NOT USED/NOT NEEDED, NO STENTS WERE PRESENT IN THE ACCESS SITE AND THERE WAS NO RESISTANCE WHEN PUTTING THE CATHETER THROUGH THE SHEATH FROM OUR ACCESS KIT. HOWEVER, THE POWER CONTROLLER DID SHOW A READING OF 3.4 WHEN THEY CLOSED THE JAWS. IT WAS REPORTED THAT THERE WAS A WARNING ¿GAP SENSOR ERROR CATHETER REPLACEMENT RECOMMENDED¿ DISPLAYED. PHYSICIAN PROCEEDED WITH PROCEDURE BECAUSE THEY WERE COMFORTABLE WITH WHAT THEY SAW ON ULTRASOUND. DURING REMOVAL, THE DID HAVE TO ACTIVATE ANOTHER CYCLE TO REMOVE THE CATHETER BECAUSE IT WOULD NOT REMOVE. THE DEVICE WAS REMOVED WITH NO HARM TO THE PATIENT AND ANASTOMOSIS SUCCESSFULLY CREATED. THE PATIENT WILL COME BACK FOR THEIR STANDARD 2 WEEK FOLLOW UP FOR PATENCY ASSESSMENT AND MATURATION PLANNING. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20704890 ↗
• MalfunctionNov 11, 2024Difficult to Remove; Mechanical Jam; Physical Resistance/Sticking; Difficult to Remove; Mechanical Jam; Physical Resistance/Sticking

  PHYSICIAN ATTEMPTED TO USE AN ELLIPSIS CATHETER DURING PATIENT TREATMENT. THE USER MANUAL/IFU WAS FOLLOWED DURING PREPARATION, PROCEDURE, AND POST-PROCEDURE. MODERATE VESSEL TORTUOSITY WAS NOTED. ARTERY DIAMETER REPORTED AS 2.9MM. VEIN DIAMETER REPORTED AS 3.5-4.0MM. THE DISTANCE BETWEEN THE ARTERY AND VEIN WAS NOT GREATER THAN 1.5MM. THE CLOSURE DISTANCE WAS LOW (LESS THAN 0.3MM). IT IS REPORTED THE CATHETER WAS UNABLE TO ACTUATE (OPEN/CLOSE) CATHETER JAWS DURING TISSUE CAPTURE. AT LEAST 2 TIMES DEVICE JAWS STUCK IN OPEN POSITION AS BUTTON WAS UNABLE TO BE PUSHED DOWN TO ENGAGE THEN CLOSE. ANATOMY MAY HAVE ADDED TO COMPLICATION OF INABILITY OF JAWS TO CLOSE WHEN PUSHING UNLOCK BUTTON. PHYSICIAN PROCEEDED TO REMOVE, DEVICE WAS STUCK INSIDE SHEATH AND WOULD NOT BUDGE, SLIGHT PUSH FORWARD 1CM AT MOST, THEN 180 REVERSE TURN TO DISENGAGE FROM TISSUE (TO UNCATCH). PULLED BACK INTO SHEATH BUT COULD ONLY COME BACK 1-2 CM AT MOST. DEVICE ACTIVATED IN SHEATH TO LOOSEN/REMOVE OUT OF SHEATH AND REMOVE IT FROM THE ARM. PHYSICIAN INSPECTED DEVICE OUTSIDE THE BODY AND CHECKED IF IT WOULD CLOSE, IT DID. CEPHALIC VEIN PARALLEL TO SKIN. SHORT PERFORATOR; 90 DEGREE BEND STRAIGHT DOWN TO ARTERY CROSS

  Patient problems: Hematoma; Pain

  MAUDE report 20652188 ↗
• InjuryOct 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE ELLIPSYS CATHETER WAS USED TO TREAT THE LEFT AVF (ARTERIOVENOUS FISTULA). TWO MEDTRONIC BALLOONS WERE LATER USED APPROXIMATELY 10 DAYS LATER TO TO TREAT STENOSIS THROUGH THE VENOUS OUTFLOW, SUBCLAVIAN VEIN AND AUXILIARY VEIN. APPROXIMATELY 2 WEEKS LATER DURING A SCHEDULED MATURATION FISTULOGRAM PROCEDURE DUE TO LESS THAN OPTIMAL FLOW DETECTED IN LEFT UPPER EXTREMITY FISTULA DUPLEX, IT WAS NOTED THAT LEFT RADIAL ARTERY WAS OCCLUDED AND THEY WERE UNABLE TO PASS A WIRE ALSO DUE TO TORTUOUS ANATOMY AND POSSIBLE VESSEL SPASM. THE PHYSICIAN WAS UNABLE TO GET WIRE FROM THE VEIN INTO ARTERY. REPEAT FISTULOGRAM WAS PERFORMED AND BALLOON ANGIOPLASTY TO LEFT PROXIMAL RADIAL ARTERY TO PERFORATOR VEIN ANASTOMOSIS WITH 6X40 NON-MEDTRONIC BALLOON WAS CARRIED OUT. FINAL IMAGING SHOWED PROXIMAL AND MID RADIAL ARTERY PATENT WITHOUT RESIDUAL STENOSIS. PATIENT RECOVERED.

  Patient problems: Obstruction/Occlusion; Stenosis

  MAUDE report 20451972 ↗
• MalfunctionJul 24, 2024Mechanical Jam; Mechanical Jam

  PHYSICIAN ATTEMPTED TO USE AN ELLIPSYS CATHETER WITH A 6FR NON-MEDTRONIC SHEATH AND AN 80CM 0.014 NITREX GUIDEWIRE DURING TREATMENT OF THE PATIENTS LEFT PROXIMAL PERFORATOR TO RADIAL ARTERY ARTERIOVENOUS FISTULA (AVF). MINIMAL VESSEL TORTUOSITY AND MINIMAL VESSEL CALCIFICATION WERE REPORTED. LESION EXHIBITED 0% STENOSIS. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE IFU (INSTRUCTION FOR USE) FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE WITHOUT ISSUE. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE DISTANCE BETWEEN THE ARTERY AND VEIN WAS 0.3MM. IT WAS REPORTED THAT THE JAWS WOULD NOT CLOSE WHEN INSERTED INTO PATIENT. PHYSICIAN TRIED TO CLOSE USING THE PULL TAB MULTIPLE TIMES UNDER ULTRASOUND GUIDANCE AND THE JAWS STILL REMAINED OPEN. PHYSICIAN SAFELY REMOVED THE DEVICE FROM THE PATIENT AND WAS ABLE TO CLOSE THE JAWS AFTER TWO TIMES OF PULLING THE TAB BACK TO CLOSED POSITION. A REPLACEMENT ELLIPSYS CATHETER FROM SHELF WAS USED IN THE SAME LOCATION WITH NO ISSUES TO COMPLETE THE PROCEDURE. A FISTULA WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19817950 ↗
• InjuryJul 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE AN ELLIPSYS CATHETER WAS USED TO TREAT THE RIGHT ARM ((B)(6) 2024). AN UNKNOWN MEDTRONIC BALLOON WAS USED TO TREAT THE CENTRAL CEPHALIC ARCH ((B)()6)2024). APPROXIMATELY 4 MONTHS POST PROCEDURE PATIENT SUFFERED STEAL SYNDROME ((B)(6) 2024). SUBJECT HAD SEVERE PAIN AND NUMBNESS ON RIGHT HAND. SUBJECT HAD FISTULOGRAM, A STENT PLACED AND RIGHT UPPER EXTREMITY ARTERIOGRAM WITH CATHETER PLACEMENT IN THE RADIAL ARTERY.

  Patient problems: Ischemia; Numbness; Pain

  MAUDE report 19675252 ↗
• MalfunctionJun 27, 2024Difficult to Remove; Detachment of Device or Device Component; Mechanical Jam; Difficult to Remove; Detachment of Device or Device Component; Mechanical Jam

  PHYSICIAN ATTEMPTED TO USE AN ELLIPSYS CATHETER DURING TREATMENT OF A SOFT TISSUE LESION IN THE PATIENTS LEFT PROXIMAL RADIAL ARTERY AND PERFORATOR VEIN. THE LEFT ANTECUBITAL PERFORATOR VEIN MEASURED 4.1 MM IN DIAMETER. THE LEFT PROXIMAL RADIAL ARTERY MEASURED 3.9 MM IN DIAMETER. THERE WAS NO SIGNIFICANT CALCIFICATION OF THE RADIAL ARTERY. THERE WAS NO VESSEL TORTUOSITY. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE IFU (INSTRUCTION FOR USE) FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE. EMBOLIC PROTECTION WAS NOT USED. THE VESSEL WAS NOT PRE OR POST DILATED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE DISTANCE BETWEEN THE PERFORATOR VEIN AND PROXIMAL RADIAL ARTERY WAS 0.6 MM. THE PROCEDURE WAS GOING VERY SMOOTHLY BUT DEVICE WOULD NOT CLOSE. CLOSURE DISTANCE WAS 5.0 MM ON POWER CONTROLLER AND DID NOT CHANGE AFTER MULTIPLE ATTEMPTS. THE JAWS DIDN'T APPEAR TO MOVE UNDER ULTRASOUND DURING CLOSURE ATTEMPTS AND NO TISSUE MOVEMENT WAS SEEN. A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19622194 ↗
• InjuryApr 23, 2024Difficult to Remove; Positioning Problem; Difficult to Remove; Positioning Problem

  PHYSICIAN ATTEMPTED TO USE AN ELLIPYSIS CATHETER WITH A 10CM 6FR NON-MEDTRONIC SHEATH AND AN 80CM 014 NITREX GUIDEWIRE DURING TREATMENT OF A SOFT TISSUE LESION IN THE PATIENTS RIGHT PROXIMAL FOREARM ARTERY AND VEIN. MODERATE VESSEL TORTUOSITY AND MINIMAL VESSEL CALCIFICATION WERE REPORTED. ARTERY/VEIN DIAMETER REPORTED AS >2MM. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE IFU (INSTRUCTION FOR USE) FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE WITHOUT ISSUE. EMBOLIC PROTECTION WAS NOT USED. THE VESSEL WAS NOT PRE OR POST DILATED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. SEVERE RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS USED. THE DISTANCE BETWEEN THE ARTERY AND VEIN WAS 1.3MM. THE CATHETER WAS UNABLE TO CROSS AND REMOVAL DIFFICULTIES WERE REPORTED. PHYSICIAN USED A BLADE TO HELP REMOVAL. VESSEL DAMAGE WAS REPORTED. THE VEIN WAS TORN WHILE TRYING TO REMOVE SHEATH AND CATHETER. AFTER THE DEVICE AND SHEATH WERE REMOVED, A PTA BALLOON WAS USED TO STOP BLEEDING AND HEM

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding; Perforation of Vessels

  MAUDE report 19164204 ↗
• InjuryApr 5, 2024Difficult to Remove; Compatibility Problem; Difficult to Remove; Compatibility Problem

  PHYSICIAN ATTEMPTED TO USE AN ELLIPSYS CATHETER WITH AN ELLIPSYS 6FR SHEATH AND A .014 NITREX GUIDEWIRE DURING TREATMENT OF THE PATIENTS LEFT CEPHALIC VEIN. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE WITHOUT ISSUE. EMBOLIC PROTECTION WAS NOT USED. THE VESSEL WAS NOT POST DILATED. THE DISTANCE BETWEEN ARTERY AND VEIN GREATER WAS LESS THAN 1.5MM. IT WAS REPORTED PHYSICIAN HAD THE DEVICE IN THE SHEATH, BUT NOTHING WAS ACTIVATED. THE SHEATH POPPED OUT AND PHYSICIAN TRIED TO PULL OUT THE DEVICE IN ORDER TO PUT THE DILATOR BACK ON THE WIRE AND PUSH THE SHEATH BACK IN. WHEN PHYSICIAN TRIED TO PULL OUT THE DEVICE FROM THE SHEATH, IT GOT CAUGHT ON THE END OF THE SHEATH AND THEY BOTH WOULDN'T COME OUT. PHYSICIAN HAD TO DO A MINOR CUT DOWN IN ORDER TO TAKE OUT THE SHEATH AND DEVICE. A REPLACEMENT ELLIPSYS SHEATH AND CATHETER WERE USED TO COMPLETE PROCEDURE. A FISTULA WAS CREATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19049171 ↗
• InjuryMar 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE A ELLIPSYS CATHETER WAS USED TO TREAT THE RIGHT ARM.  4 DAYS POST PROCEDURE PATIENT SUFFERED COMPLETE OCCLUSION. NO BRUIT OR THRILL. THE EVENT WAS TREATED WITH A PERCUTANEOUS INTERVENTION. PATIENT RECOVERING. THE INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE INDEX DEVICE, INDEX PROCEDURE OR SECONDARY PROCEDURE. THE SPONSOR ASSESSED THE EVENT AS POSSIBLY RELATED TO THE INDEX PROCEDURE AND NOT RELATED TO THE INDEX DEVICE OR SECONDARY PROCEDURE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 18985068 ↗
• InjuryFeb 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE A ELLIPSYS CATHETER WAS USED TO TREAT THE LEFT ARM. APPROXIMATELY 1 WEEK POST PROCEDURE PATIENT SUFFERED STENOSIS OF VENOUS OUTFLOW OF AV FISTULA ANASTOMOSIS. SUBJECT WAS IN FOR 1-WEEK STUDY VISIT AND ULTRASOUND SHOWED DECREASED FLOW SPECIFICALLY IN THE VENOUS OUTFLOW. A FISTULOGRAM WAS DONE THAT DAY TO AUGMENT THE VENOUS OUTFLOW TRACT AND HELP THE FISTULA MATURE. FISTULOGRAM AND IVUS REVEALED SEVERAL FOCI OF STENOTIC VENOUS BANDS ALONG THE CEPHALIC VENOUS OUTFLOW ALONG WITH ANOMALOUS INSERTION OF THE LEFT CEPHALIC VEIN INTO THE AXILLARY VEIN AND THE AXILLA SUBCLAVIAN JUNCTION. BALLOON ANGIOPLASTY OF THE SUBCLAVIAN VEIN, AXILLARY VEIN, AND CEPHALIC VEIN. POST PROCEDURE FISTULOGRAM REVEALED GOOD FLOW THROUGHOUT THE TREATED REGIONS WITH AUGMENTED THRILL OVER THE AV FISTULA ON PALPATION. PATIENT RECOVERED.

  Patient problems: Stenosis

  MAUDE report 18702469 ↗
• InjuryJan 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE A ELLIPSYS CATHETER WAS USED TO TREAT A LESION LOCATED IN THE RIGHT ARM. 4 DAYS POST PROCEDURE PATIENT SUFFERED STENOSIS AT AV FISTULA ANASTOMOSIS AND PERFORATING VEIN. AT ULTRASOUND, CORE LAB NOTED THERE TO BE STENOSIS AT AV FISTULA ANASTOMOSIS. PATIENT CAME IN FOR A SCHEDULED FISTULOGRAM TO PROMOTE MATURATION. FISTULOGRAM REVEALED THE ANASTOMOSIS AND PERFORATING VEIN WERE PATENT BUT WITH SEVERAL AREAS OF HIGH GRADE STENOSIS. BALLOON ANGIOGRAPHY WAS PERFORMED ON THE ANASTOMOSIS WITH RESOLUTION OF STENOSIS AT THE END OF THE PROCEDURE. PATIENT RECOVERED.

  Patient problems: Stenosis

  MAUDE report 18501460 ↗
• InjuryJan 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE A ELLIPSYS CATHETER WAS USED TO TREAT A LESION LOCATED IN THE LEFT ARM. APPROXIMATELY 1 MONTH POST PROCEDURE PATIENT SUFFERED STENOSIS AT AV FISTULA ANASTOMOSIS AND CEPHALIC VEIN. SUBJECT HAD A PRE-PLANNED FISTULOGRAM FOR MATURATION OF THE STUDY AVF. DURING THE PROCEDURE, MODERATE STENOSIS WAS FOUND IN THE AV FISTULA WHICH WAS TREATED WITH BALLOON ANGIOPLASTY. THERE WAS ALSO FOUND TO BE MULTIPLE AREAS OF NARROWING THROUGHOUT THE LENGTH OF THE CEPHALIC VEIN WHICH WAS ALSO TREATED WITH BALLOON ANGIOPLASTY. THE COMPLETION STUDY SHOWED IMPROVEMENT IN FLOW. PATIENT RECOVERED.

  Patient problems: Stenosis

  MAUDE report 18501437 ↗
• InjuryJan 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE A ELLIPSYS CATHETER WAS USED TO TREAT THE LEFT ARM. APPROXIMATELY 1 WEEK POST PROCEDURE PATIENT SUFFERED STENOSIS AT AVF ANASTOMOSIS. AT THE 1 WEEK VISIT THERE WAS NOTED TO BE SLIGHT STENOSIS AT THE AV FISTULA ANASTOMOSIS. PATIENT HAD A ROUTINE FISTULOGRAM TO ENHANCE MATURATION OF FISTULA. FISTULA CONFIRMED STENOSIS AT THE ANASTOMOSIS. STENOSIS WAS TREATED WITH BALLOON ANGIOPLASTY WITH MUCH IMPROVED FLOW INTO BOTH THE CEPHALIC AND BASILIC VEINS. PATIENT RECOVERED.

  Patient problems: Stenosis

  MAUDE report 18451997 ↗
• InjuryDec 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE A ELLIPSYS CATHETER WAS USED TO TREAT A LESION LOCATED IN THE LEFT ARM. APPROXIMATELY 5 MONTHS POST PROCEDURE PATIENT SUFFERED A CLOTTED AV FISTULA. THE PATIENT WAS TREATED WITH PERCUTANEOUS INTERVENTION. PATIENT RECOVERED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 18371734 ↗
• InjuryDec 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE A ELLIPSYS CATHETER WAS USED TO TREAT A LESION LOCATED IN THE RIGHT ARM. APPROXIMATELY 1 WEEK POST PROCEDURE THE PATIENT UNDERWENT A SECONDARY PROCEDURE DURING WHICH A MEDTRONIC BALLOON WAS USED TO TREAT THE ANASTOMOSIS. 12 DAYS POST INDEX PROCEDURE PATIENT SUFFERED RIGHT ARTERIAL ANASTOMOSIS STENOSIS. PATIENT PRESENTS FOR FOLLOW UP WITH NO THRILL OR BRUIT OF RIGHT PROXIMAL FOREARM AV FISTULA. FISTULAGRAM COMPLETED ON SAME DAY REVEALS 80% STENOSIS OF THE RIGHT PROXIMAL RADIAL ARTERY STENOSIS OF THE AREA BETWEEN THE BIFURCATION AND AND THE ANASTOMOSIS. PATIENT WAS TREATED USING A MEDTRONIC BALLOON WITH ANGIOPLASTY OF THE ARTERIAL ANASTOMOSIS/PERFORATOR VEIN AND OF THE PROXIMAL PART OF THE RADIAL ARTERY, RESULTING IN IMPROVED FLOW AND LOW RESISTANCE WAVEFORM. WEEK 4 FOLLOW UP DUS SHOWED PATENT ANASTOMOSIS WITH A FLOW OF 0.64 CM/S AND TARGET VESSEL FLOW OF 649.9 ML/MIN, INDICATING RESOLUTION OF RIGHT ARTERIAL ANASTOMOSIS STENOSIS. PATIENT RECOVERED.

  Patient problems: Stenosis

  MAUDE report 18361716 ↗