OUTBACK OTB59120ARecalls & reported problems

Summary

The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 20705032067574), received between Feb 16, 2017 and May 5, 2026 — classified as 9 injuries, 73 malfunctions.

The most frequently reported specific device problem is “Fracture” (39 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 25 most recent of 82 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2026Fracture

  AS REPORTED, THE DOCTOR INSERTED THE OUTBACK ELITE THROUGH A NON-CORDIS 6F 40CM SHEATH, OVER A .035 GUIDEWIRE, POSITIONING IT FOR NEEDLE FIRING. HOWEVER, IMMEDIATELY AFTER FIRING, IT WAS OBSERVED THAT THE RADIOPAQUE TIP OF THE OUTBACK DETACHED INSIDE THE PATIENT, MAKING IT IMPOSSIBLE TO REMOVE. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, THE INFORMATION WAS NOT OBTAINED AFTER MULTIPLE ATTEMPTS. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25089554 ↗
• MalfunctionDec 10, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED, A RADIOPAQUE MARKER OF THE OUTBACK ELITE 120CM CATHETER BROKE OFF INSIDE A PATIENT DURING SURGERY. THE EVENT WAS REPORTED BY THE PATIENT TO THE MRI TEAM AND NO ADDITIONAL INFORMATION IS AVAILABLE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23771987 ↗
• InjuryAug 28, 2025Fracture; Difficult to Remove; Fracture; Difficult to Remove

  AS REPORTED, WHILE TRYING TO RE-ENTER THE TRUE LUMEN DISTAL TO AN OCCLUSION IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) WITH A 120CM OUTBACK ELITE RE-ENTRY CATHETER WHICH WAS ADVANCED OVER A 300CM STABILIZER EXTRA SUPPORT .014 STEERABLE GUIDEWIRE, THE USER ADVANCED AND RETRACTED THE CANNULA THREE TO FOUR TIMES WITHOUT ISSUE, BUT WITHOUT OBTAINING RE-ENTRY. THE OUTBACK WAS NOT ABLE TO FULLY ADVANCE THROUGH THE SUBINTIMAL SPACE AT THE LESION AND WAS UNABLE TO RE-ENTER THE TRUE LUMEN, WITH NO CALCIUM NOTED AT THE RE-ENTRY AREA. THE STABILIZER GUIDEWIRE WAS UNABLE TO ADVANCE OUT OF THE 22-GAUGE CANNULA ON THE SIDE OF THE CATHETER, AND THE OUTBACK RE-ENTRY CATHETER WAS REMOVED FROM THE PATIENT FOR INSPECTION. UPON REMOVAL AND INSPECTION, THE USER NOTICED THAT THE 22-GAUGE CANNULA WAS NO LONGER ATTACHED TO THE CATHETER. IT WAS NOTICED ON FLUOROSCOPY THAT THE DETACHED CANNULA WAS WEDGED IN THE SUBINTIMAL PLANE. ABNORMAL FORCE WAS REQUIRED DURING WITHDRAWAL, NECESSITATING A SECOND SET OF HANDS TO MAINTAIN WIRE POSITION WHILE THE DAMAGED OUTBACK WAS SLOWLY REMOVED. THE SEPARATED CANNULA DID NOT REMAIN ON THE WIRE AND WAS NOT REMOVED FROM THE PATIENT, REMAINING LODGED IN THE SUBINTIMAL PLAN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22911393 ↗
• InjuryJun 27, 2025Fracture; Fracture

  AS REPORTED, DURING REMOVAL OF A 120CM OUTBACK RE-ENTRY CATHETER, THE END OF THE DEVICE BROKE AWAY FROM THE MAIN BODY AND REMAINED IN THE PATIENT. THE PROCEDURE CONTINUED WITH SUCCESSFUL STENTING OF THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) AND THE SEPARATED END OF THE OUTBACK CATHETER WAS WEDGED AGAINST THE ARTERY WALL. THIS WAS DURING A PROCEDURE IN WHICH A PERIPHERAL VASCULAR ANGIOGRAM WAS PERFORMED ON THE RIGHT LEG. THE DEVICE WAS STORED PER LABELING AND WAS OPENED IN THE STERILE FIELD. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22345987 ↗
• MalfunctionMay 16, 2025Fracture; Fracture

  AS REPORTED, THE DISTAL END OF THE OUTBACK ELITE BROKE AND SEPARATED INTO TWO PIECES WHILE IN THE INTRODUCER DURING PASSAGE OF THE ILIAC CROSS. IT WAS IMPOSSIBLE TO USE THE MEDICAL DEVICE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WAS PREPARED AS SPECIFIED IN THE USER MANUAL. NO APPARENT DAMAGES TO THE DEVICE WERE NOTICED BEFORE USE. ALL SPECIFIED PORTS WERE FLUSHED/EMPTIED. THE PORTS WERE FLUSHED/EMPTIED, FOLLOWED BY A 30-SECOND PAUSE, THEN FLUSHED/EMPTIED AGAIN. HEPARINIZED SALINE SOLUTION WAS USED FOR THE PREPARATION AND FLUSHING OF ALL PORTS. THE ACTUATION OF THE CANNULA OR THE DISTAL TIP WAS VERIFIED OUTSIDE THE PATIENT. THE CATHETER WAS KEPT IN A STRAIGHT ORIENTATION, WITHOUT "SLACK" DURING PREPARATION. DURING PREPARATION, THE CANNULA/NEEDLE ACTUATED SMOOTHLY. THE CATHETER WAS NOT COILED AT ANY POINT BEFORE INSERTION. THE TIP OF THE CANNULA WAS FULLY RETRACTED BEFORE INSERTION. THE DEPLOYMENT SLIDER ON THE HANDLE WAS LOCKED IN THE PROXIMAL POSITION. THERE WAS NO DIFFICULTY RETRACTING THE CANNULA INTO THE CATHETER. A NON-CORDIS .014 GUIDEWIRE WAS USED. THERE WAS DIFFICULTY ADVANCING THE OUTBACK OVER THE GUIDE WIRE. THE CORRECT ORIENTATION WAS NOT APPLICABLE UNDER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22036779 ↗
• MalfunctionApr 22, 2025Fracture; Fracture

  AS REPORTED, THE SLIDER BUTTON ON A 120CM OUTBACK ELITE RE-ENTRY CATHETER COULD NOT BE DEPRESSED TO ADVANCE THE SLIDER, AND THE CANNULA COULD NOT BE DEPLOYED. THERE WERE NO REPORTED INJURIES TO THE PATIENT. THE INTENDED LESION WAS THE SUPERFICIAL FEMORAL ARTERY (SFA) WHICH HAD A CHRONIC TOTAL OCCLUSION (CTO). THE VESSEL CHARACTERISTICS INCLUDED SEVERE CALCIFICATION AND NO TORTUOSITY. NO DAMAGES OR ANOMALIES WERE NOTED TO THE DEVICE OR PACKAGING PRIOR TO OPENING, NOR WERE THERE ANY NOTED TO THE DEVICE PRIOR TO USE IN THE PATIENT. HEPARINIZED SALINE WAS USED FOR PREPARATION AND FLUSHING OF ALL PORTS. CANNULA ACTUATION WAS VERIFIED OUTSIDE OF THE PATIENT, AND THE CANNULA/NEEDLE ACTUATED SMOOTHLY. THE CATHETER WAS HELD IN A STRAIGHT ORIENTATION, WITH NO SLACK DURING PREPARATION. THE NEEDLE WAS CONFIRMED TO BE FULLY RETRACTED BEFORE INSERTING THE DEVICE INTO THE PROCEDURAL SHEATH. A RETROGRADE APPROACH WAS TAKEN AT THE ACCESS SITE. NO RESISTANCE OR FRICTION WAS EXPERIENCED WHILE ADVANCING THE OUTBACK CATHETER OVER THE UNKNOWN GUIDEWIRE, AND NO DIFFICULTY WAS EXPERIENCED WHILE TRACKING THE DEVICE TO THE LESION. THE NEEDLE WAS RETRACTED WHEN THE DEVICE WAS REMOVED FROM THE PATIENT. THERE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21883825 ↗
• MalfunctionMar 25, 2025

  A PATIENT PRESENTED FOR AN ELECTIVE LOWER EXTREMITY ANGIOGRAM SECONDARY TO SFA [SUPERFICIAL FEMORAL ARTERY] OCCLUSIONS. DURING THE PROCEDURE, THE TIP OF THE MEDICAL DEVICE BROKE OFF AND BECAME LODGED IN PATIENT'S ARTERY. VESSEL WITH CHRONIC CALCIFICATION. NO HARM /INJURY TO PATIENT. PATIENT DISCHARGED TO HOME SAME DAY.

  Patient problems: Calcium Deposits/Calcification; Device Embedded In Tissue or Plaque

  MAUDE report 21686947 ↗
• MalfunctionMar 21, 2025Fracture; Fracture

  AS REPORTED, THE PHYSICIAN PUSHED THE TRIGGER FORWARD ON A 120CM OUTBACK ELITE RE-ENTRY CATHETER TO THROW THE NEEDLE OVER A NON-CORDIS GUIDEWIRE, BUT THE NEEDLE COULD NOT BE RETRACTED AGAIN. AN ATTEMPT WAS MADE TO PULL THE TRIGGER BACK, BUT THE NEEDLE WOULD NOT COME BACK. THE TRIGGER AND THE INNER CATHETER OF THE OUTBACK RE-ENTRY CATHETER SEEMED TO BE MOVING INDEPENDENTLY FROM THE STATIONARY NEEDLE AT THE DISTAL TIP. AN X-RAY IMAGE WAS PROVIDED WHICH SHOWS THAT THE CANNULA/NEEDLE APPEARS TO BE FRACTURED/SEPARATED. THE PHYSICIAN POPPED THE HANDLE OPEN AND TRIED PULLING THE INNER CATHETER OUT OVER THE NON-CORDIS GUIDEWIRE, BUT THE WIRE KEPT COMING BACK WITH THE CATHETER. THE ENTIRE DEVICE WITH THE NEEDLE STILL EXPOSED HAD TO BE PULLED THROUGH THE PATIENT, INTO AN UNKNOWN UP AND OVER SHEATH, AND OUT OF THE BODY. THERE WERE NO REPORTED INJURIES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED. THE DEVICE WILL BE RETUNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21664819 ↗
• MalfunctionMar 7, 2025Fracture; Fracture

  AS REPORTED, AN OUTBACK ELITE CATHETER HAD AN ISSUE DURING A CASE. THE RE-ENTRY NEEDLE ACTUALLY FELL OFF IN THE UP AND OVER SHEATH BEFORE EVEN GETTING TO THE LESION. NO RESISTANCE WAS ENCOUNTERED WHEN TORQUING THE DEVICE, BUT ABNORMAL FORCE WAS REQUIRED WHILE ATTEMPTING TO GET OVER THE BIFURCATION, THIS IS WHERE THE DISTAL PART OF THE DEVICE BROKE OFF INSIDE THE SHEATH. THE BROKEN PART WAS SNARED OUT WITHOUT ANY HARM TO THE PATIENT. THE DEVICE WAS PREPARED AS SPECIFIED BY THE INSTRUCTIONS FOR USE. NO APPARENT DAMAGE TO THE DEVICE WAS NOTICED PRIOR TO USE. ALL SPECIFIED PORTS WERE FLUSHED, FOLLOWED BY A 30-SECOND PAUSE, AND THEN FLUSHED AGAIN USING HEPARINIZED SALINE. CANNULA ACTUATION WAS VERIFIED OUTSIDE OF THE PATIENT. THE CATHETER WAS HELD IN A STRAIGHT ORIENTATION WITH "NO SLACK" DURING PREPARATION, AND THE CANNULA/NEEDLE ACTUATED SMOOTHLY. THE CATHETER WAS NOT COILED PRIOR TO INSERTION, AND THE CANNULA TIP WAS FULLY RETRACTED BEFORE INSERTION. THE HANDLE DEPLOYMENT SLIDE WAS LOCKED IN THE PROXIMAL POSITION, AND THERE WAS NO DIFFICULTY RETRACTING THE CANNULA BACK INTO THE CATHETER. THERE WAS A ONE-TO-ONE RESPONSE TO THE NOSECONE WHILE ROTATING THE ROTATING HEMOSTATIC VALVE DUR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21547434 ↗
• MalfunctionNov 27, 2024Retraction Problem; Retraction Problem

  AS REPORTED, THERE WAS DIFFICULTY RETRACTING THE NEEDLE ON A 120CM OUTBACK ELITE RE-ENTRY CATHETER. THE ISSUE OCCURRED AFTER THE DEVICE WAS REMOVED FROM THE PATIENT. A NEW OUTBACK RE-ENTRY CATHETER WAS USED AS A REPLACEMENT. THERE WERE NO REPORTED ISSUES WITH THE DEVICE WHEN IT WAS INITIALLY USED INSIDE OF THE PATIENT AND THERE WERE NO REPORTED PATIENT INJURIES. THE ISSUE OCCURRED PRIOR TO REINSERTING THE DEVICE INTO THE PATIENT. THE DEVICE WAS PROPERLY STORED AND OPENED IN THE STERILE FIELD. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20795642 ↗
• MalfunctionOct 7, 2024Difficult to Remove; Difficult to Remove

  AS REPORTED, THE OUTBACK ELITE NEEDLE GOT JAMMED IN DEVICE AND WOULD NOT ADVANCE. ONCE IT DID ADVANCE IT CAME OUT THROUGH THE SIDE OF CATHETER BODY ABOVE THE AREA IT WAS SUPPOSED TO AND NOT THE END. THE LESION WAS NOT TREATED SUCCESSFULLY. THERE WAS NO RESISTANCE OR DIFFICULTY IN REMOVING THE OUTBACK FROM THE PATIENT. THERE WAS NO REPORTED INJURY TO THE PATIENT.THE DEVICE WAS PREPARED AS SPECIFIED BY THE INSTRUCTIONS FOR USE (IFU), WITH NO APPARENT DAMAGE NOTICED PRIOR TO USE. ALL SPECIFIED PORTS WERE FLUSHED, FOLLOWED BY A 30-SECOND PAUSE AND THEN FLUSHED AGAIN USING HEPARINIZED SALINE. CANNULA ACTUATION WAS VERIFIED OUTSIDE OF THE PATIENT, AND THE CATHETER WAS HELD IN A STRAIGHT ORIENTATION WITH NO SLACK DURING PREPARATION. THE CANNULA AND NEEDLE ACTUATED SMOOTHLY, AND THE CATHETER WAS NOT COILED PRIOR TO INSERTION. THE CANNULA TIP WAS FULLY RETRACTED, THE HANDLE DEPLOYMENT SLIDE WAS LOCKED IN THE PROXIMAL POSITION, AND THERE WAS NO DIFFICULTY RETRACTING THE CANNULA BACK INTO THE CATHETER DURING PREPARATION. A ONE-TO-ONE RESPONSE TO THE NOSECONE WAS NOTED WHILE ROTATING THE ROTATING HEMOSTATIC VALVE, AND THERE WERE NO DIFFICULTIES IN ADVANCING THE OUTBACK OVER THE GUIDEWIRE OR TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20385776 ↗
• MalfunctionJul 7, 2024Fracture; Fracture

  AS REPORTED, THERE WAS HEAVILY CALCIFIED CTO IN THE LEFT SFA. THE TEAM WAS ABLE TO INITIALLY RETRACT AND DEPLOY THE OUTBACK ELITE NEEDLE, BUT IT FELT STIFFER THAN NORMAL. AFTER FLUSHING IT ANOTHER TIME, WHEN THE PHYSICIAN WENT TO RETRACT THE NEEDLE, HE/SHE NOTICED THAT IT WAS KINKED AND WOULD NO LONGER RETRACT BACK INTO THE HOUSING OF THE OUTBACK. IT NEVER ENTERED THE PATIENT BODY, SO NO HARM WAS DONE TO THE PATIENT. THE DEVICE WAS STORED AND PREPARED PROPERLY. THE TEAM FLUSHED AND REMOVED THE PROTECTIVE CAP OFF THE NEEDLE. ALL SPECIFIED PORTS WERE FLUSHED WITH HEPARINIZED SALINE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19686845 ↗
• InjuryJun 13, 2024Fracture; Fracture

  AS REPORTED, THE TIP OF A 120CM OUTBACK ELITE RE-ENTRY CATHETER BROKE OFF WHILE INSIDE OF THE PATIENT. THE SEPARATED SEGMENT WAS ABLE TO BE REMOVED AND THE PATIENT IS REPORTEDLY DOING WELL POST PROCEDURE. THE DEVICE WAS STORED AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WERE NO DAMAGES OR ANOMALIES NOTED TO THE DEVICE PRIOR TO USE INSIDE OF THE PATIENT. THERE WAS NO DIFFICULTY EXPERIENCED WHILE ADVANCING THE OUTBACK DEVICE INTO THE PROCEDURAL SHEATH AND ABNORMAL FORCE WAS NOT REQUIRED AT ANY TIME DURING THE PROCEDURE. THERE WAS NO DIFFICULTY REMOVING THE MAIN PORTION OF THE OUTBACK ELITE CATHETER. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19530608 ↗
• InjuryMay 28, 2024Fracture; Fracture

  AS REPORTED, DURING RE-TREATMENT WITH THE OUTBACK, A SMALL PIECE OF THE DEVICE WAS LEFT EXTRAVASAL, NEAR THE VESSEL OF THE PATIENT. THERE WAS NO DIFFICULTY OR RESISTANCE NOTED WHILE REMOVING FROM THE PATIENT, BUT LT-MARKER WAS LEFT IN SITU. THE SURGEON CONFIRMED THAT THE PATIENT WAS INFORMED AND THAT THERE IS NO NEED TO REMOVE THIS PIECE. PROCEDURE WAS PROLONGED AND FINALIZED WITH A SECOND OUTBACK. THERE WAS NO HARM TO THE PATIENT. THE DEVICE WAS PREPARED AS SPECIFIED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO APPARENT DAMAGE TO THE DEVICE NOTICED PRIOR TO USE. ALL SPECIFIED PORTS FLUSHED, FOLLOWED BY A 30 SECOND PAUSE, AND THEN FLUSHED AGAIN. THE PORTS WERE FLUSHED WITH HEPARINIZED SALINE. CANNULA ACTUATION ACTION WAS VERIFIED OUTSIDE OF THE PATIENT. THE CATHETER WAS HELD IN A STRAIGHT ORIENTATION, WITH ¿NO SLACK¿ DURING PREPARATION. THE CANNULA/NEEDLE ACTUATED SMOOTHLY DURING PREP. THE DEVICE WA NOT COILED AT ANY TIME PRIOR TO INSERTION. THE CANNULA WAS FULLY RETRACTED PRIOR TO INSERTING. THERE WAS NO DIFFICULTY WILE RETRACTING THE CANNULA. A .014 NON-CORDIS WIRE WAS USED WITH THE OUTBACK. THERE WAS NO DIFFICULTY NOTED WHILE ADVANCING THE OUTBACK OVER THE WIRE. PROPER ORIEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19405042 ↗
• MalfunctionMay 15, 2024Fracture; Difficult to Remove; Retraction Problem; Fracture; Difficult to Remove; Retraction Problem

  AS REPORTED, THE OUTBACK ELITE WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU) BY A TRAINED OPERATOR. ONCE THE DEVICE WAS INSERTED INTO THE PATIENT, THE PHYSICIAN LOCATED WHERE HE WISHED TO USE THE DEVICE. HE DEPLOYED THE NEEDLE CANNULA OUT AND IT WOULD NOT PULL BACK INTO THE DEVICE TO BE DEPLOYED AGAIN. THEY TRIED FLUSHING THE DEVICE WHILE IN THE PATIENT AND THE NEEDLE CANNULA STILL WOULD NOT RETRACT BACK INTO THE DEVICE. THE PHYSICIAN HAD TO REMOVE THE DEVICE WITH THE NEEDLE CANULA STILL OUT. THERE WAS DIFFICULTY REMOVING THE DEVICE DUE TO THE NEEDLE BEING STUCK OUT. THE CASE WAS COMPLETED WITH THE USE OF A NEW OUTBACK. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE PRODUCT WAS STORED AND HANDLED PER THE INSTRUCTIONS FOR USE. THE DEVICE WAS INSPECTED AND PREPPED ACCORDING TO THE IFU. THERE WAS NOTHING UNUSUAL NOTED ABOUT THE DEVICE PRIOR TO USE. ALL SPECIFIED PORTS WERE FLUSHED WITH HEPARINIZED SALINE. THE CATHETER WAS HELD IN A STRAIGHT ORIENTATION WITH ¿NO SLACK¿ DURING PREP. THERE WAS NO DIFFICULTY RETRACTING THE CANNULA DURING PREP. PROPER ORIENTATION WAS CONFIRMED UNDER FLUORO PRIOR TO ACTUATION OF THE CANNULA. THE ¿L¿ MARKER LEG, ON THE CATHETER ¿LT¿ DIRECTIONAL MARKER BAN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19326260 ↗
• MalfunctionFeb 9, 2024Fracture; Retraction Problem; Fracture; Retraction Problem

  AS REPORTED, THE NEEDLE OF AN OUTBACK ELITE 120CM RE-ENTRY CATHETER WOULD NOT RETRACT CORRECTLY AFTER IT WAS DEPLOYED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS USED IN THE PATIENT FOR THE RE-ENTRY TO THE TRUE LUMEN ON THE SUPERFICIAL FEMORAL ARTERY (SFA). THE NEEDLE WAS ABLE TO BE ¿FLEX¿ BACK INTO THE CATHETER IN ORDER TO REMOVE THE DEVICE FROM THE PATIENT. OTHER PROCEDURAL DETAILS WERE REQUESTED BUT ARE UNKNOWN, UNAVAILABLE, NOT ANSWERED, OR NOT APPLICABLE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18676817 ↗
• MalfunctionOct 2, 2023Fracture; Difficult to Remove; Fracture; Difficult to Remove

  AS REPORTED, WHILE USING A 120CM OUTBACK ELITE RE-ENTRY CATHETER, THE DEVICE BECAME STUCK INSIDE OF A NON-CORDIS GUIDING SHEATH. AN ATTEMPT TO REMOVE THE OUTBACK ELITE RE-ENTRY CATHETER WAS MADE; HOWEVER, THERE WAS RESISTANCE DURING THE REMOVAL AND THE OUTBACK ELITE RE-ENTRY CATHETER WAS SEPARATED. THE SEPARATED SEGMENT REMAINED INSIDE OF THE NON-CORDIS GUIDING SHEATH AND WAS ABLE TO BE REMOVED BY REMOVING THE GUIDING SHEATH. THERE WERE NO DEVICE FRAGMENTS LEFT INSIDE OF THE PATIENT AND THERE WERE NO REPORTED PATIENT INJURIES. TWO NON-CORDIS GUIDEWIRES WERE REPORTEDLY USED DURING THIS PROCEDURE. THIS WAS DURING A PROCEDURE TO TREAT A CHRONIC TOTALLY OCCLUDED (CTO) LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) IN WHICH A CROSS-OVER APPROACH WAS MADE. THE LESION WAS LOCATED AT A BIFURCATION; HOWEVER, THE BIFURCATION DID NOT HAVE AN ACUTE ANGULATION. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17850537 ↗
• MalfunctionSep 28, 2023Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  AS REPORTED, THE NEEDLE OF AN OUTBACK ELITE 120CM RE-ENTRY CATHETER WOULD NOT COME OUT OF THE DEVICE. THERE WAS RESISTANCE OR DIFFICULTY REMOVING THE OUTBACK FROM THE PATIENT; THE DEVICE WAS STUCK ON THE WIRE. THEN ALL PRODUCTS WERE REMOVED AND A NEW WIRE AND SECOND OUTBACK DEVICE WAS TRIED. THE SECOND OUTBACK DEPLOYED THE NEEDLE AND THE WIRE WAS DEPLOYED BUT THE NEEDLE CANNULA WAS NOT IN THE VESSEL SO THE DOCTOR TRIED TO WITHDRAW THE WIRE TO DEPLOY THE NEEDLE CANNULA AGAIN BUT THE WIRE WOULD NOT COME BACK INTO THE DEVICE. AT THAT TIME THE NEEDLE WAS RETRACTED AND THE OUTBACK WAS ABORTED; ALL PRODUCTS WERE REMOVED AND A PEDAL STICK WAS ACHIEVED. THERE WAS NO REPORTED PATIENT INJURY. THE LESION WAS THE SUPERFICIAL FEMORAL ARTERY (SFA) WHICH HAD MODERATE CALCIFICATION AND MILD TORTUOSITY IN ADDITION TO A CHRONIC TOTAL OCCLUSION (CTO) WITH NO IN-STENT RESTENOSIS. A RETROGRADE APPROACH WAS USED FOR ACCESS. THERE WERE NO DEVICE DAMAGES OR ANOMALIES NOTED PRIOR TO USE IN THE PATIENT. HEPARINIZED SALINE WAS USED FOR PREPARATION AND FLUSHING OF ALL PORTS. CANNULA ACTUATION WAS VERIFIED OUTSIDE THE PATIENT AND THE CANNULA/NEEDLE ACTUATED SMOOTHLY AND PROPER ORIENTATION WAS CONFIRMED UNDER F

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17835538 ↗
• MalfunctionJul 13, 2023Fracture; Fracture

  AS REPORTED, AFTER ADVANCING THROUGH AN UNKNOWN 45CM CATHETER SHEATH INTRODUCER (CSI) WITH A 120CM OUTBACK ELITE RE-ENTRY CATHETER, THERE WAS DIFFICULTY ADVANCING THE RE-ENTRY CATHETER OVER A NON-CORDIS .014 HYDROPHILIC BALANCED HEAVY WEIGHT GUIDEWIRE. THE OUTBACK ELITE RE-ENTRY CATHETER WAS REMOVED IN ORDER TO RE-FLUSH BOTH OF ITS PORTS AND WIPE DOWN THE NON-CORDIS GUIDEWIRE. A SECOND ATTEMPT TO INSERT THE OUTBACK RE-ENTRY CATHETER WAS MADE, AND THE DEVICE WAS ABLE TO ADVANCE A LITTLE FURTHER BUT WAS AGAIN STUCK ON THE NON-CORDIS GUIDEWIRE IN THE MID-SUPERFICIAL FEMORAL ARTERY (SFA) AND WAS UNABLE TO CANNULATE THROUGH THE DISSECTION. A SECOND OUTBACK RE-ENTRY SYSTEM WAS THEN OPENED AND USED, AND THIS DEVICE FUNCTIONED PROPERLY. THERE WAS NO REPORTED INJURY TO THE PATIENT OR ADVERSE EVENTS DURING THIS PROCEDURE. THIS WAS DURING A PROCEDURE TO TREAT A CHRONIC TOTALLY OCCLUDED (CTO) SFA LESION WHICH HAD CALCIFICATION BUT NO TORTUOSITY. THE DEVICE WAS STORED, HANDLED, AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND HEPARINIZED SALINE WAS USED TO FLUSH ALL OF THE PORTS. THE DEVICE WAS HELD IN A STRAIGHT ORIENTATION WITH NO SLACK DURING PREPARATION. THE CANNULA ACTUATION WAS VERIFIED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17315322 ↗
• MalfunctionApr 24, 2023Retraction Problem; Retraction Problem

  AS REPORTED, THE NEEDLE OF A 120CM OUTBACK ELITE RE-ENTRY CATHETER DID NOT RETRACT AFTER DEPLOYMENT. THERE WERE NO REPORTS OF PATIENT INJURY. THE DEVICE WAS NOT RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16797518 ↗
• MalfunctionMar 14, 2023Fracture; Retraction Problem; Fracture; Retraction Problem

  AS REPORTED, THE 120CM OUTBACK ELITE DEVICE WAS PROPERLY USED; HOWEVER, THEY WERE UNABLE TO WITHDRAW THE NEEDLE DESPITE SEVERAL ATTEMPTS. THE NEEDLE COULD NOT BE WITHDRAWN AFTER DEPLOYMENT. THE DEVICE WAS PULLED INTO THE SHEATH WITH NEEDLE IN DEPLOYED POSITION. THE USER TRIED SPLITTING HANDLE AND REMOVING INNER CORE AND NEEDLE. IT IS UNSURE IF THE NEEDLE IS SEPARATED INTO TWO PIECES. NO SURGERY WAS NEEDED WITH NO INJURY TO THE PATIENT. THE PATIENT RECOVERED SUCCESSFULLY. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO APPARENT DAMAGE TO THE DEVICE PRIOR TO USE. ALL SPECIFIED PORTS WERE FLUSHED. THE PORTS WERE FLUSHED, FOLLOWED BY A 30 SECOND PAUSE, AND THEN FLUSHED AGAIN. HEPARINIZED SALINE WAS USED FOR PREPARATION AND FLUSHING OF ALL PORTS. ACTUATION OF THE CANNULA WAS VERIFIED OUTSIDE THE PATIENT. THE CANNULA ACTUATED SMOOTHLY DURING PREP. THE CATHETER WAS HELD IN A STRAIGHT ORIENTATION, WITH ¿NO SLACK¿ DURING PREPARATION. INITIALLY, THERE WAS A ONE TO ONE RESPONSE TO THE NOSECONE WHILE ROTATING THE ROTATING HEMOSTATIC VALVE DURING PREP THE CANNULA TIP WAS FULLY RETRACTED BEFORE INSERTION. THE HANDLE DEPLOYMENT SLIDE WAS LOCKED IN THE PROXIMAL POSITION. TH

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16539710 ↗
• MalfunctionJan 17, 2023Fracture; Fracture

  AS REPORTED, A 120CM OUTBACK ELITE RE-ENTRY CATHETER WAS USED WITH A NON-CORDIS WIRE BUT WAS UNABLE TO CROSS. THEREFORE, THE CANNULA WAS ATTEMPTED TO ¿GO BACK¿ BUT IT WAS UNABLE TO MOVE AT ALL. FURTHER EVENT CLARIFICATION PROVIDED NOTED THAT THE CANNULA DID NOT PROGRESS FROM THE FALSE LUMEN TO THE TRUE LUMEN. THE ENTIRE SYSTEM WAS REMOVED FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY. THE TARGET LESION WAS REPORTED TO BE THE SUPERFICIAL FEMORAL ARTERY (SFA) AND THE INTENDED PROCEDURE AN ENDOVASCULAR THERAPY (EVT) CASE. THE VESSEL CHARACTERISTICS AT TARGET SITE INCLUDED SEVERE CALCIFICATION, MILD TORTUOSITY, ONE-HUNDRED-PER CENT STENOSIS, MILD ACUTE ANGLE, AND MODERATE BIFURCATING. THE DEVICE WAS STORED AND PREPPED AS SPECIFIED BY THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE NOTICED TO THE OUTBACK DEVICE PRIOR TO OPENING THE PACKAGE. ALL THE SPECIFIED PORTS WERE FLUSHED, FOLLOWED BY A THIRTY SECOND PAUSE, AND THEN FLUSHED AGAIN. HEPARINIZED SALINE WAS USED FOR PREPARATION AND FLUSHING OF ALL PORTS. THE CANNULA ACTUATION ACTION WAS VERIFIED OUTSIDE THE PATIENT. THE CATHETER WAS HELD IN A STRAIGHT ORIENTATION WITH ¿NO SLACK¿ DURING PREPARATION. THE NEEDLE RETRACTED AS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16184920 ↗
• MalfunctionJan 13, 2023Fracture; Fracture

  AS REPORTED, DURING THE USE OF A 120CM OUTBACK ELITE RE-ENTRY CATHETER THE CANNULA TIP WAS UNABLE TO EXTEND FROM THE LATERAL PORT AFTER THE HANDLE DEPLOYMENT SLIDE RELEASE BUTTON WAS DEPRESSED. AS A RESULT, THE DEVICE WAS REMOVED, AND A NEW OUTBACK RE-ENTRY CATHETER WAS USED AS A REPLACEMENT. THERE WAS NO REPORTED INJURY TO THE PATIENT AND NO ADVERSE EVENTS ASSOCIATED WITH THE USE OF THIS DEVICE. THIS WAS DURING A PROCEDURE TO TREAT A LESION IN THE ILIAC ARTERY WHICH HAD CALCIFICATION AND TORTUOSITY. THE DEVICE WAS STORED, HANDLED, AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WAS NO DAMAGE TO THE DEVICE OBSERVED PRIOR TO USE. ALL SPECIFIED PORTS WERE FLUSHED WITH HEPARINIZED SALINE AND THE DEVICE WAS HELD IN A STRAIGHT ORIENTATION WITH NO SLACK DURING PREPARATION. CANNULA ACTUATION WAS VERIFIED OUTSIDE OF THE PATIENT AND THE DEVICE WAS NOT COILED AT ANY POINT PRIOR TO ITS INSERTION. THE CANNULA TIP WAS FULLY RETRACTED PRIOR TO INSERTION AND THE DEPLOYMENT SLIDE WAS LOCKED IN THE PROXIMAL POSITION. THE ¿L¿ MARKER LEG WAS POINTING TOWARDS THE TARGET RE-ENTRY SITE AND WAS VERIFIED UNDER FLUOROSCOPY. THE STORED TORQUE IN THE CATHETER SHAFT WAS RELEASED AFTER THE CANNULA TIP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16164071 ↗
• MalfunctionJan 5, 2023Fracture; Fracture

  AS REPORTED, THE OUTBACK DEVICE WAS TORQUED SEVERAL TIMES TO THE SHEATH TO CORRECTLY ORIENT THE "L" TOWARDS THE ARTERY. IT SKIPPED EACH TIME. THERE WAS NO RESISTANCE WHILE TORQUING THE DEVICE, BUT WHEN THE PHYSICIAN TORQUED THE DEVICE, THE TORQUE WASN¿T TRANSMITTED IMMEDIATELY. THE L MARKERS TWISTED A BIT AND THEN JUMPED AND RETURNED AT THE SAME POSITION. THE DEVICE WAS THEN BROUGHT UP IN THE INTRO TO GIVE THE RIGHT ORIENTATION AND THEN LOWERED AGAIN. THERE, THE NEEDLE CAME OUT FOR THE FIRST TIME, BUT WE WERE STILL SUBINTIMALLY BECAUSE THE .014 GUIDE WAS STILL LOOPING. THE DEVICE WAS THAN RE-ENTERED AND IT WAS CONFIRMED THAT THE NEEDLE WOULD NOT DEPLOY A SECOND TIME. THE UNKNOWN .014 GUIDEWIRE STILL CAME OUT DISTALLY. THE PHYSICIAN DECIDED TO TAKE THE OUTBACK OUT OF THE PATIENT AND ON THE TABLE THE DOCTOR COULD SEE THAT THE OUTBACK WAS COMPLETELY KINKED AND THEREFORE IMPOSSIBLE TO REUSE. THE OUTBACK WAS REMOVED FROM THE PATIENT WITHOUT DIFFICULTY. THE WIRE WAS NOT KINKED AFTER THE DEVICE WAS REMOVED FROM THE PATIENT. THE CASE WAS COMPLETED WITH UNKNOWN GUIDEWIRES AND A NON-CORDIS DEVICE. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE OUTBACK WAS USED TO TREAT AN OCCLUSION IN THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16110112 ↗
• MalfunctionSep 30, 2022Retraction Problem; Retraction Problem

  AS REPORTED, THE CANNULA OF A 120CM OUTBACK ELITE RE-ENTRY CATHETER WOULD NOT DEPLOY DURING TREATMENT OF A SUPERFICIAL FEMORAL ARTERY (SFA) LESION. AS A RESULT, THE OUTBACK DEVICE WAS REPLACED WITH A NEW 120CM OUTBACK ELITE RE-ENTRY CATHETER WHICH WAS ABLE TO BE DEPLOYED TO CONTINUE THE PROCEDURE. THERE WAS NO REPORTED INJURY TO THE PATIENT. AN IPSILATERAL APPROACH WAS USED FOR THIS PROCEDURE. THE TARGET SFA LESION HAD MILD CALCIFICATION AND MILD VESSEL TORTUOSITY. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WAS NO APPARENT DAMAGE TO THE DEVICE PRIOR TO USE. ALL SPECIFIED PORTS WERE FLUSHED WITH HEPARINIZED SALINE, FOLLOWED BY A 30 SECOND PAUSE AND THEN FLUSHED AGAIN. THE DEVICE WAS HELD IN A STRAIGHT ORIENTATION WITH NO SLACK DURING PREPARATION. THERE WAS NO DAMAGE TO THE DISTAL TIP OF THE DEVICE. THE DEVICE WAS NEVER COILED PRIOR TO ITS INSERTION. THERE WAS NO DIFFICULTY ADVANCING THE DEVICE TOWARDS THE LESION, AND PROPER ORIENTATION WAS CONFIRMED UNDER FLUOROSCOPY PRIOR TO ACTUATION OF THE CANNULA. THERE WAS NO RESISTANCE WHEN TORQUING THE DEVICE. THE DEVICE WAS NOT HELD BY THE BLACK HANDLE DURING TORQUING AND THE DEVICE WAS NOT STUCK IN THE LESION WHEN B

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15521571 ↗