THRUWAY™ M001492971Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 08714729717188), received between Sep 21, 2020 and Sep 24, 2026 — classified as 13 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (27 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 45 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Break

  During a reported complex atherectomy procedure involving a severely calcified, moderately tortuous distal superficial femoral artery (SFA) lesion with 100% stenosis, the physician advanced the Jetstream atherectomy too far, resulting in fracture and detachment of the distal tip of the guidewire, with the fractured segment remaining within the patient. An attempt was made to retrieve the detached wire tip using a snare; however, retrieval was unsuccessful. As stent implantation was already planned, the detached wire fragment was secured against the vessel wall with the implanted stent. No additional actions were taken. No patient effects were reported.

  Patient problems: Foreign Body In Patient

  MAUDE report 50883381 ↗
• MalfunctionAug 14, 2026Entrapment of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50253325 ↗
• InjuryAug 12, 2026Break

  Patient problems: Foreign Body In Patient

  MAUDE report 50227841 ↗
• MalfunctionFeb 27, 2026Break

  EVENT DESCRIPTION: PER MEDWATCH, IT WAS REPORTED THAT: GUIDE WIRE BROKE OFF INSIDE A PATIENT DURING AN ENDOVASCULAR PROCEDURE. ADDITIONAL INFORMATION RECEIVED 27FEB2026: QUESTION: WAS THE DEVICE PRE-INSPECTED FOR KINKS, DAMAGE, OR IRREGULARITIES PRIOR TO USE? ANSWER: YES. QUESTION: WAS THERE ANY DAMAGE NOTED PRIOR TO USE? ANSWER: NO. QUESTION:WHAT SPECIFIC ENDOVASCULAR PROCEDURE WAS BEING PERFORMED? ANSWER:ANGIOGRAM WITH INTERVENTION QUESTION:WHAT WAS THE ACCESS SITE? ANSWER:FEMORAL ACCESS. QUESTION:WHAT DEVICES WERE USED IN CONJUNCTION WITH THE GUIDEWIRE (PLEASE LIST ALL DEVICES USED DURING THE PROCEDURE, INCLUDE THE MODEL, BRAND NAME, SIZES, ETC.)? ANSWER: JETSTREAM ROTATIONAL ATHERECTOMY (2.4 MM) BALLOON ANGIOPLASTY 5 X 100 MM STERLING BALLOON 6 X 100 MM ELUVIA STENT BALLOON ANGIOPLASTY 4 X 100 MM STERLING BALLOON DRUG-COATED BALLOON ANGIOPLASTY 5 X 100 MM RANGER BALLOON FOR 3-MINUTE DURATION QUESTION:WERE THERE MULTIPLE DEVICE EXCHANGES OVER THE WIRE? ANSWER: YES (SEE ABOVE) QUESTION:WAS THE WIRE USED TO CROSS A DIFFICULT OR CALCIFIED LESION? ANSWER: NO QUESTION:WAS THE LESION HEAVILY CALCIFIED? ANSWER: YES QUESTION:DID THE END USER ENCOUNTER ANY RESISTANCE CROSSING THE LESION?

  Patient problems: Foreign Body In Patient

  MAUDE report 24475467 ↗
• MalfunctionFeb 5, 2026Break

  EVENT DESCRIPTION: WHEN THE TECHNICIAN REMOVED THE WIRE, HE NOTICED THAT IT HAD A SLIGHT DEFORMATION, REQUIRING ANOTHER WIRE. SUPPLEMENTAL INFORMATION INDICATED THAT THE DEFORMATION WAS FIRST NOTICED AFTER THE DISPENSER ASSEMBLY HAD BEEN REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24272856 ↗
• MalfunctionJan 7, 2026Entrapment of Device

  ADDITIONAL INFORMATION PROVIDED: QUESTION: PLEASE LIST ALL OTHER DEVICES USED DURING THE PROCEDURE, INCLUDE THE MODEL, BRAND NAME, SIZES, ETC.? ANSWER: ONLY JETSTREAM WAS USED DURING THE PROCEDURE. QUESTION: WAS THERE ANY RESISTANCE FELT DURING INSERTION OR ADVANCEMENT OF THE WIRE TO TREATMENT SITE? ANSWER: YES. QUESTION: WERE THERE ANY PATIENT COMPLICATIONS DURING OR AFTER THE PROCEDURE THAT WERE RELATED TO THE PRODUCT ISSUE? ANSWER: NO. QUESTION: WHAT DOES THE END USER BELIEVE CAUSED AND/OR CONTRIBUTED TO THE REPORTED ISSUE? ANSWER: THE END USER BELIEVES IT IS A QUALITY ISSUE OF THE DEVICE. QUESTION: HOW WAS THE PROCEDURE COMPLETED? ANSWER: THE PROCEDURE WAS COMPLETED AFTER THE CATHETER WAS WITHDRAWN FOLLOWING ROTATIONAL CUTTING AND THEN DILATED WITH A BALLOON. QUESTION: WAS FLUOROSCOPY IN USE DURING THE PROCEDURE? ANSWER: YES. QUESTION: WAS THERE ANY DAMAGE NOTED TO THE WIRE PRIOR TO OR AFTER USE? IF SO, PLEASE DESCRIBE. ANSWER: NO. QUESTION: WAS TYPE OF DAMAGE WAS NOTED ON THE CATHETER AFTER USE, AND WAS THIS A CONTRIBUTING FACTOR TO THE ENTRAPMENT BETWEEN THE TWO DEVICES? PLEASE DESCRIBE. ANSWER: AFTER USING THE CATHETER, IT WAS DISCOVERED THAT THE CATHETER WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23991735 ↗
• InjuryDec 22, 2025Break; Break

  DESCRIBE THE EVENT OR PROBLEM: WHEN ATTEMPTING TO REMOVE PIONEER RE-ENTRY DEVICE THE VERY TIP OF THE THRUWAY WIRE SHEARED OFF AND REMAINED IN THE DISSECTED PLAIN OF THE SFA [SUPERFICIAL FEMORAL ARTERY]. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? ANGIOGRAM. WHAT PROBLEM DID THE USER HAVE: OTHER.

  Patient problems: Insufficient Information

  MAUDE report 23865552 ↗
• MalfunctionDec 11, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT: IT WAS STUCK WITH THE THRUWAY. PROCEDURE COMPLETED USING A DIFFERENT DEVICE (SAME MODEL) PATIENT OUTCOME: NO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23779844 ↗
• MalfunctionDec 3, 2025Entrapment of Device; Entrapment of Device

  ADDITIONAL INFORMATION PROVIDED: QUESTION: THE EVENT DESCRIPTION STATES, AFTER THE THRUWAY GUIDEWIRE WAS UNPACKING, IT WAS FOUND THAT THE GUIDEWIRE AND THE TIP OF THE ROTARY CUTTING CATHETER WERE STUCK DURING THE ROTARY CUTTING PROCESS. WHAT IS MEANT BY AFTER THE THRUWAY GUIDEWIRE WAS UNPACKING? ANSWER: AFTER UNPACKING THE PACKAGE, THE PHYSICIAN INSERTED THE GUIDEWIRE INTO THE LESION. QUESTION: PLEASE LIST ALL OTHER DEVICES USED DURING THE PROCEDURE, INCLUDE THE MODEL, BRAND NAME, SIZES, ETC. ANSWER: ONLY THE VASCULAR PLAQUE RESECTION CONTROL DEVICE WAS USED. QUESTION: WAS THERE ANY RESISTANCE FELT DURING INSERTION OR ADVANCEMENT OF THE WIRE OR CATHETER TO TREATMENT SITE? ANSWER: NO. QUESTION:PLEASE CLARIFY, WERE BOTH THE CATHETER AND WIRE REMOVED AS ONE UNIT? ANSWER: YES. QUESTION: HOW WAS THE WIRE REMOVED FROM THE PATIENT? ANSWER: THE CATHETER AND WIRE WERE REMOVED AS ONE UNIT. QUESTION:WAS THE SAME CATHETER USED TO COMPLETE THE PROCEDURE? ANSWER: REPLACED A NEW CATHETER TO COMPLETE THE PROCEDURE. QUESTION:WERE THERE ANY PATIENT COMPLICATIONS DURING THE PROCEDURE? ANSWER: NO. QUESTION:WHAT DOES THE END USER BELIEVE CAUSED AND/OR CONTRIBUTED TO THE REPORTED ISSUE? ANSWER: THE PHYS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23709197 ↗
• InjuryJul 8, 2025Break; Break

  ADDITIONAL INFORMATION: QUESTION: LISTING OF THE MODEL OF ALL DEVICES USED IN THE PROCEDURE, INCLUDE THE MODEL, BRAND NAMES, SIZES ETC.? ANSWER: JETSTREAM2.4/3.4MM QUESTION: WHAT OTHER DEVICE(S) WERE BEING USED AT THE TIME THE DETACHMENT OCCURRED? ANSWER: JETSTREAM2.4/3.4MM QUESTION: WHEN DURING THE PROCEDURE DID THE DETACHMENT OCCUR? ANSWER: AFTER CUTTING, THE JETSTREAM WAS REMOVED AND FLUOROSCOPY WAS PERFORMED. QUESTION: WAS RESISTANCE NOTED PRIOR TO THE DETACHMENT OR AT ANY TIME DURING INSERTION, ADVANCING, OR WITHDRAWING THE WIRE? ANSWER: UNKNOWN. QUESTION: WAS GUIDEWIRE MOVEMENT EXAMINED UNDER FLUOROSCOPY THROUGHOUT THE PROCEDURE TO MONITOR THE THRUWAY GUIDEWIRE? ANSWER: YES. QUESTION: WAS TORQUE APPLIED TO THE GUIDEWIRE UNDER RESISTANCE AT ANY TIME DURING THE PROCEDURE? ANSWER: UNKNOWN. QUESTION: WHAT DOES THE END USER/PHYSICIAN BELIEVE CAUSED THE WIRE DETACHMENT? ANSWER: IN THE ANGIO TEST, THE TIP OF THE PRODUCT WAS CRUMPLED AND BROKEN, SO IT BECAME STUCK SOMEWHERE IN THE BLOOD VESSEL, AND IT MAY HAVE BROKEN OFF WHEN THE PRODUCT WAS PULLED OUT. QUESTION: BEYOND THE WIRE BEING SNARED, WAS THERE ANY PATIENT COMPLICATION DUE TO THE DETACHMENT? ANSWER: NO. QUESTION: WAS THERE AN

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22440076 ↗
• InjuryJun 25, 2025Entrapment of Device; Entrapment of Device

  EVENT DESCRIPTION: AFTER OPENING THE BLOOD VESSEL, THE 0.018 INCH GUIDEWIRE WAS REPLACED WITH THE THRUWAY GUIDEWIRE. THE TIP OF THE GUIDEWIRE CROSSED THE LESION AND REACHED THE DISTAL LANDING AREA. THEN THE JESTREAM CATHETER WAS ASSEMBLED ACCORDING TO THE IFU AND DELIVERED INTO THE BODY ALONG THE THRUWAY GUIDEWIRE AFTER COMPLETING THE PRIMING OUTSIDE THE PATIENT. THE JESTREAM (HEREINAFTER REFERRED TO AS JS) DEVICE WAS STARTED IN BLADE DOWN MODE FOR PROCEDURE, AND THE JS CATHETER WAS SLOWLY PUSHED TO CUT THE PLAQUE ACCORDING TO THE IFU. WHEN THE CATHETER WAS PUSHED FOR ABOUT 5MM, THE JS CATHETER SOUND WAS ABNORMAL, AFFECTED THE GUIDEWIRE ROTATED ALONG WITH THE CATHETER. THE PHYSICIAN STOPPED THE OPERATION AND WITHDREW THE CATHETER. IT WAS FOUND THAT THE CATHETER AND THE GUIDEWIRE HAD BECOME LOCKED TOGETHER AND COULD NOT BE SEPARATED. THE PHYSICIAN REPLACED THE NEW GUIDEWIRE AND JS CATHETER TO COMPLETE THE PROCEDURE. THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Vascular Dissection

  MAUDE report 22326794 ↗
• MalfunctionJun 18, 2025Entrapment of Device; Entrapment of Device

  EVENT DESCRIPTION: IT WAS REPORTED THAT: IT EITHER KINKED OR GOT STUCK DURING USE IN COMBINATION WITH THE JETSTREAM. SHAPING: NO PHYSICIAN COMMENTS: PATIENT OUTCOME: NO PATIENT INJURY INTRODUCER SHEATH USED: YES, ABLE TO USE THE DEVICE, DESTINATION 7FR. ADDITIONAL INFORMATION RECEIVED FROM THE DISTRIBUTOR ON 16JUN2025: QUESTION: WHAT WAS THE ISSUE NOTED WITH THE THRUWAY? RESPONSE: WHEN USED IN CONJUNCTION WITH JETSTREAM, THE THRUWAY BECOME STUCK BECAUSE IT MAY HAVE KINKED. QUESTION: WAS THE THRUWAY WIRE KINKED? IF SO, WHERE WAS THE KINK LOCATED? RESPONSE: UNKNOWN, THE THRUWAY MAY HAVE KINKED QUESTION: WAS THE THRUWAY WIRE STUCK WITH THE JETSTREAM DEVICE? RESPONSE: YES QUESTION: WERE THE THRUWAY AND THE JETSTREAM DEVICES REMOVED FROM THE PATIENT AS ONE UNIT OR WHERE THEY REMOVED SEPARATELY FROM THE PATIENT? RESPONSE: THE THRUWAY AND THE JETSTREAM DEVICES WERE REMOVED FROM THE PATIENT AS ONE UNIT QUESTION: PLEASE CLARIFY WHAT DEVICES WERE USED TO COMPLETE THE PROCEDURE (A NEW THRUWAY WIRE AND A NEW JETSTREAM DEVICE, A NEW THRUWAY WIRE AND THE ORIGINAL JETSTREAM DEVICE, A NEW JETSTREAM DEVICE AND THE ORIGINAL THRUWAY WIRE) RESPONSE: REPLACED WITH A NEW THRUWAY AND A NEW JETSTREAM (UPS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22283940 ↗
• InjuryMar 17, 2025Break; Break

  EVENT DESCRIPTION: PROCEDURE WAS A LE ANGIO. 7FR DESTINATION SHEATH UP AND OVER. .014 X 300CM THRUWAY WIRE CROSSED INTO THE RT PERONEAL. BALLOONED THE RT. PERONEAL WITH 2.5X 200 ARMADA BALLOON. JETSTREAM (JS) 2.1/3.0 OF THE RT. SFA INTO PROXIMAL POPLITEAL WAS SUCCESSFUL. WHEN 'WALKING OUT' THE JS OVER THE .014 THRUWAY THE WIRE KINKED (OUTSIDE OF THE BODY). WIRE ACCESS WAS LOST. UPON REWIRING THE VESSEL WITH A .035 STIFF GLIDE WIRE, A 1CM-2CM WIRE TIP WAS NOTED IN THE MID PERONEAL. WE LOOKED AT THE THRUWAY WIRE THAT WAS REMOVED AND THE TIP APPEARED TO BE MISSING. THE DR. PASSED A BERN CATHETER PAST THE WIRE TIP. THE WIRE TIP DID NOT MOVE. A SECOND .014 THRUWAY WIRE CROSSED INTO THE RT. PERONEAL. THE SAME 2.5 X 200 ARMADA WAS INTRODUCED PAST THE BROKEN WIRE TIP AND INFLATED. AGAIN, THE WIRE TIP DID NOT APPEAR TO MOVE. IT WAS THEN NOTED THE WIRE TIP MIGHT BE IN A COLLATERAL. SEVERAL IMAGES WERE TAKEN. PATIENT HAD BRISK FLOW TO THE FOOT. THE CASE ENDED. PATIENT PRESENT AT TIME OF EVENT? YES. PATIENT COMPLICATIONS: OTHER. PROVIDE DETAILS FOR "OTHER" PATIENT COMPLICATION: TIP OF WIRE BROKE OFF. LEFT IN PATIENTS LEFT PERONEAL (OR COLLATERAL BRANCH). IN THE PHYSICIAN'S OPINION, DID THE DEV

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21618883 ↗
• MalfunctionNov 8, 2024Entrapment of Device; Entrapment of Device

  THIS PRODUCT WAS USED IN COMBINATION WITH JETSTREAM SC1.6, THE LESION PART WAS ABLATED, AND ATTEMPTED TO REMOVE THE JETSTREAM CATHETER, HOWEVER, IT GOT STUCK WITH THIS PRODUCT. THEREFORE, THIS PRODUCT WAS REMOVED FROM THE BODY ALONG WITH THE JETSTREAM CATHETER. THIS PRODUCT AND JETSTREAM WERE ABLE TO BE UNSTUCK OUTSIDE THE BODY, HOWEVER, THIS PRODUCT HAS BEEN DEFORMED; THEREFORE, A NEW PRODUCT WAS USED, AND THE PROCEDURE WAS CONTINUED. THE PROCEDURE WAS THEN COMPLETED SUCCESSFULLY. PATIENT OUTCOME: NO PATIENT INJURY. ADDITIONAL INFORMATION RECEIVED 05NOV2024: THE INFORMATION INDICATES, "THIS PRODUCT AND JETSTREAM WERE ABLE TO BE UNSTUCK OUTSIDE THE BODY, HOWEVER, THIS PRODUCT HAS BEEN DEFORMED; THEREFORE, A NEW PRODUCT WAS USED" QUESTION: IS REFERENCE TO ]THIS PRODUCT' THE THRUWAY GUIDEWIRE? ANSWER: YES QUESTION: WERE THE JETSTREAM AND THRUWAY WIRE ENTRAPPED? ANSWER: YES, STUCK QUESTION: UPON SEPARATING THE DEVICES OUTSIDE THE PATIENT, WHAT PRODUCT WAS DEFORMED? ANSWER: THRUWAY GUIDEWIRE. QUESTION: WAS THE PRODUCT DEFORMED DURING USE OR UPON SEPARATING THE DEVICES OUTSIDE THE PATIENT? ANSWER: UPON SEPARATING THE DEVICES OUTSIDE THE PATIENT QUESTION: WHAT DOES THE END USER BELIEVE C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20646258 ↗
• InjuryOct 24, 2024Break; Break

  EVENT DESCRIPTION: MD TRAVERSED A HIGHLY CALCIFIED SFA CTO UTILIZING A GLIDEADVANTAGE WIRE AND TRAILBLAZER CATHETER. ONCE CTO WAS SUCCESSFULLY CROSSED MD EXCHANGED FOR 014 THRUWAY TO PERFORM JETSTREAM ATHERECTOMY. AFTER SUCCESSFUL COMPLETION OF ATHERECTOMY THE MD WANTED TO EXCHANGE THE WIRE FOR BALLOONING AND STENTING. AS THE MD WAS REMOVING THE THRUWAY WIRE HE NOTICED THAT THE RADIOPAQUE TIP HAD COME OFF OF THE END OF THE WIRE. THE MD ATTEMPTED TO SNARE THE WIRE TIP BUT WAS UNSUCCESSFUL. AT THIS POINT THE DOCTOR DECIDED TO BALLOON THE VESSEL, DEPLOY A STENT, AND TRAP THE WIRE TIP. THE MD WAS ALREADY PLANNING ON STENTING POST ATHERECTOMY. WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: ATTEMPTED SNARE WHAT IS THE NEXT COURSE OF ACTION?: STENT DEPLOYED, TRAPPING WIRE TIP PATIENT PRESENT AT TIME OF EVENT?: YES PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS WAS ISSUE PRESENT UPON OPENING PACKAGE?: NO PHOTO OR VIDEO OF ISSUE: NO QUESTION: SPECIFY THE APPROXIMATE LOCATION OF THE BREAK/FRACTURE ON THE DEVICE (CATHETER, SHEATH, TELESCOPE, TIP, ETC.)? ANSWER: 3CM-5CM OF THE WIRE TIP FRACTURED OFF OF THE END OF THE WIRE QUESTION: WAS THE DEVICE REMOVED FROM THE PATIENT IN ONE PIEC

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 20521517 ↗
• MalfunctionJul 16, 2024Entrapment of Device; Entrapment of Device

  EVENT DESCRIPTION: THE DOCTOR DID A CASE WITH JETSTREAM SYSTEM, AND HE GOT THE IMPRESSION THAT SOME FINE CALCIUM PARTICLES ENTERED INSIDE THE CATHETER BETWEEN THE GUIDE AND THE CATHETER. SO THESE PARTICLES JAMMED THE CATHETER AND THE GUIDE THRUWAY TOGETHER AND THE DOCTOR WAS OBLIGED TO PULL OUT EVERYTHING AND LOST HIS ACCESS. THE GUIDE WAS A THRUWAY 300CM. ADDITIONAL INFORMATION: QUESTION: WHAT IS THE LOT NUMBER OF THE THRUWAY DEVICE? ANSWER: 7234278. QUESTION: WAS THE PROCEDURE COMPLETED ON THE SAME DAY AS THE INITIAL PROCEDURE. ANSWER: PROCEDURE WAS COMPETED AT THE CASE ITSELF. ONE CASE ONLY-ISSUE WITH JAMMED CATHETER, BUT ALL WAS DONE AND COMPLETED. QUESTION: WAS ATHERECTOMY LUBRICANT USED? ANSWER: NO LUBRICANT . QUESTION: DURING USE, WAS THE TIP OF THE GUIDEWIRE 10CM FROM THE DISTAL TIP OF THE CATHETER? ANSWER: YES, AND MORE. QUESTION: WERE THERE ANY PATIENT COMPLICATIONS? ANSWER: NOTHING QUESTION: NAME OF PROCEDURE? ANSWER: SFA ATHERECTOMY . QUESTION: LISTING AND MODEL OF ANY OTHER DEVICES USED DURING THE PROCEDURE, INCLUDE THE MODEL, BRAND NAME, SIZES, ETC. ANSWER: JETSTREAM . QUESTION: DID THIS EVENT OCCUR DURING INSERTION, ADVANCEMENT, OR WITHDRAWAL OF THE JETSTREAM? ANSWER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19752111 ↗
• MalfunctionOct 30, 2023Break; Break

  IT WAS REPORTED THAT: EVENT; DEVICE SEPARATION OCCURRED. WAS THERE ANY APPEARANCE ABNORMALITY BEFORE USE? NO. WAS RESISTANCE FELT DURING INSERTION? NO. WAS RESISTANCE FELT DURING REMOVAL? YES. DETAILS OF SEPARATION POSITION.; DISTAL SIDE FROM THE CENTER OF THE WIRE. DURING DEVICE OPERATION AFTER THE SHEATH CAME OUT, IT GOT SEPARATED FROM THE KINKED PART. REMAINS INSIDE THE BODY; NONE. REMOVAL METHOD; IT WAS REMOVED NORMALLY FROM THE SEPARATED PART OUTSIDE THE BODY. PATIENT OUTCOME: NO PATIENT INJURY. ADDITIONAL INFORMATION: QUESTION: WHAT IS MEANT BY DEVICE SEPARATION OCCURRED? ANSWER: THE WIRE WAS FRACTURED. QUESTION: WHAT IS MEANT BY AFTER THE SHEATH CAME OUT, IT GOT SEPARATED FROM THE KINKED PART'? ANSWER: WHILE OPERATING THE PART OF THE SHEATH THAT PROTRUDES FROM THE PATIENT'S BODY, THE WIRE KINKED AND WAS FRACTURED AT THAT PART. QUESTION: WHAT IS MEANT BY IT WAS REMOVED NORMALLY FROM THE SEPARATED PART OUTSIDE THE BODY? ANSWER: THE FRACTURED PART COULD BE REMOVED FROM THE BODY BY PULLING ON THE PART THAT WAS PROTRUDING FROM THE BODY. QUESTION: IF FRACTURED MATERIAL WAS PRESENT, WHEN DID THE FRACTURE DAMAGE OCCUR (INSIDE OR OUTSIDE THE PATIENT BODY)? ANSWER: THE PART WHERE THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18029055 ↗
• MalfunctionOct 17, 2023Entrapment of Device; Entrapment of Device

  THE SHEATH USED WAS A 7F DESTINATION FOR THE CONTRALATERAL APPROACH. THE ANGLE OF THE CIA BRANCH WAS TOO TIGHT TO ROTATE THE DESTINATION TO THE CONTRALATERAL SIDE, AND THERE WAS A LOT OF TROUBLE WITH BALLOON ANCHORS, ETC., BUT IT MANAGED TO BE ROTATED TO THE CONTRALATERAL SIDE. JETSTREAM 1.85 WAS USED, BUT THE ROTATION STOPPED WHEN ATTEMPTED TO BREAK THROUGH THE STENOSIS WHERE CALCIFICATION WAS THE MOST SEVERE. THERE WAS NO PROBLEM WHEN THE LESION IN FRONT OF IT WAS CUT, BUT A LOT OF RESISTANCE WAS FELT WHEN THE CATHETER WAS BROUGHT TO THE LESION. IT ROTATED FINE AT THE START BUT STOPPED AFTER ABOUT 3 SECONDS. IT WAS STUCK WITH THE WIRE, SO IT WAS ABLE TO BE COLLECTED BY TOTAL REMOVAL. THE SHAFT OF THE THRUWAY WAS KINKED IN SOME PLACES, AND RESISTANCE WAS FELT WHEN CROSSING THROUGH THE CIA BRANCH, PROBABLY DUE TO THE TIGHT ANGLE OF THE CIA, THE CATHETER AND WIRE KINKED AND COULD NO LONGER BE USED. PATIENT OUTCOME: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17953317 ↗
• MalfunctionAug 16, 2023Entrapment of Device; Entrapment of Device

  EVENT DESCRIPTION: A KINK OCCURRED AND THE JETSTREAM CATHETER COULD NOT BE REMOVED. WAS THERE ANY ABNORMALITY ON THE APPEARANCE BEFORE USAGE? NO. WHICH LOCATION AND WHAT KIND OF DAMAGE WAS FOUND? MID . PATIENT OUTCOME: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17558317 ↗
• MalfunctionJun 6, 2023Break; Break

  EVENT DESCRIPTION: AFTER COMPLETING THE PROCEDURE WITH JETSTREAM, THE THRUWAY GUIDE WAS STUCK AND DID NOT LEAVE THE EQUIPMENT, WHEN THE DOCTORS WERE ABLE TO REMOVE THE GUIDE, THEY FOUND THAT THE TIP WAS BROKEN IN THE SAME PLACE AS A PIECE OF CALCIUM. WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: N/A. WHAT IS THE NEXT COURSE OF ACTION?: FINALIZED THE CASE, PATIENT WAS DISCHARGED. PATIENT PRESENT AT TIME OF EVENT?: YES. PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS. WAS ISSUE PRESENT UPON OPENING PACKAGE?: NO. PHOTO OR VIDEO OF ISSUE: YES. QUESTION: HOW WAS THE DETACHED PORTION OF THE DEVICE REMOVED (I.E. PULLED, SNARED ETC)? ANSWER: THE DOCTOR PASSED HER FINGER AND IT BROKE. QUESTION: PLEASE SPECIFY THE APPROXIMATE LOCATION OF THE FRACTURE ON THE DEVICE? ANSWER: AT THE TIP. QUESTION: WAS THE DEVICE REMOVED FROM THE PATIENT INTACT/FRACTURED POST PROCEDURE? ANSWER: YES. QUESTION: WAS THIS PORTION OF THE DEVICE OUTSIDE OF THE BODY AT THE TIME OF THE FRACTURE? ANSWER: YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17075637 ↗
• InjuryMay 11, 2023Break; Break

  EVENT DESCRIPTION: DURING THE PROCEDURE WITH JETSTREAM AFTER THE PHYSICIAN REMOVED THE CATHETER FROM JET NOTICED THAT THE GUIDEWIRE BROKE INSIDE THE PATIENT'S ARTERY, THE SFA INJURY WAS TREATED BY AN OPEN PROCEDURE AND THE GUIDEWIRE BROKEN IN THE PATIENT WAS REMOVED BY THE PHYSICIAN AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. MEDICAL OR SURGICAL INTERVENTIONS: AN OPEN SURGERY WAS PERFORMED TO FINALIZE THE PROCEDURE AND REMOVE THE BROKEN GUIDEWIRE IN THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 16911667 ↗
• MalfunctionMay 3, 2023Entrapment of Device; Entrapment of Device

  PER CNF, IT WAS REPORTED THAT: THIS DEVICE WAS USED DURING THE JETSTREAM PROCEDURE. THE RECOMMENDED SHEATH FOR USING JETSTREAM THAT WAS KEPT AT THE HOSPITAL WAS FOUND TO BE DEFECTIVE WHEN OPENED, SO THE TERUMO 7FR SHEATH WAS UNAVOIDABLY USED BECAUSE ALL THE STOCKS WAS USED UP. WHEN JETSTREAM WAS TRIED TO BE REMOVED AFTER THE PROCEDURE WAS COMPLETED, IT WAS FOUND TO BE STUCK INTO THIS DEVICE. THE TREATMENT WAS SUCCESSFULLY COMPLETED AND NO ADVERSE EVENT TO THE PATIENT WAS CONFIRMED. ADDITIONAL INFORMATION RECEIVED FROM THE DISTRIBUTOR ON APRIL 28, 2023 CONFIRMING THE JETSTREAM BECAME STUCK WITH A THRUWAY DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16863081 ↗
• MalfunctionMar 31, 2023Break; Break

  ADDITIONAL INFORMATION RECEIVED ON APRIL 4, 2023: THE DR TRIED TO PULL THE THRUWAY WIRE WITH AN UNKNOWN MEDICAL INSTRUMENT, GRABBED THE WIRE TO PULL IT OUT, AND NOTICED IT WAS BROKEN. THE WIRE WAS INSIDE THE PATIENT WHEN THE DOCTOR TRIED TO PULL THE WIRE OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16656164 ↗
• InjuryMar 2, 2023Break; Break

  EVENT DESCRIPTION: DR WAS USING THRUWAY WIRE WITH JET STREAM IN THE SFA FOR ARTERIOSCLEROSIS 4 TO 6 PASSES BLADES DOWN AND THEN BLADES UP WHEN WIRE BROKE. DR SAID HE TRIED TO SNARE THE LOST PIECE BUT WAS UNSUCCESSFUL. DR APPARENTLY BALLOONED IT INTO THE WALL OF SFA. DR REPORTED THE INCIDENT TO ME SO THAT I CAN PLACE IT UDM KID TO SEND IT FOR INVESTIGATION. WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: DR TRIED TO SNARE BROKEN OFF PEACE OUT BUT WAS UNSUCCESSFUL WHAT IS THE NEXT COURSE OF ACTION?: PLACE PRODUCT IN UDM KID AND SEND IT FOR INVESTIGATION PATIENT PRESENT AT TIME OF EVENT?: YES. PATIENT COMPLICATIONS: OTHER . IN THE PHYSICIAN'S OPINION, DID THE DEVICE OR PROCEDURE CAUSE OR CONTRIBUTE TO THE PATIENT COMPLICATION?: YES . PLEASE DESCRIBE THE WAY IN WHICH THE DEVICE OR PROCEDURE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATION?: PIECE OF WIRE STAYED BEHIND IN PATIENT MEDICAL OR SURGICAL INTERVENTIONS: APPARENTLY TRIED TO SNARE THE WIRE THAT BROKE OFF BUT WAS UNSUCCESSFUL THEY BALLOON IT INTO THE WALL OF THE SFA. PATIENT ADMITTED TO HOSPITAL BEYOND THE STANDARD OF CARE: YES. PATIENT DISCHARGED FROM HOSPITAL?: UNKNOWN. PATIENT OUTCOME: EXPECTED TO FULLY RECOVER. REA

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 16470638 ↗
• MalfunctionDec 27, 2022Entrapment of Device; Entrapment of Device

  EVENT DESCRIPTION: PER CNF, IT WAS REPORTED THAT: EVENT OTHERS (PLEASE SPECIFY THE DETAILS IN THE EVENT DESCRIPTION COLUMN.) SHAPING? NO. THE WIRE AND CATHETER GOT STUCK WHILE USING JETSTREAM XC 2.1/3.0LOT29360600 SO IT WAS COMPLETELY REMOVED. PROCEDURE OUTCOME: COMPLETED WITH ANOTHER OF SAME DEVICE INTRODUCER SHEATH USED? YES. ABLE TO USE THE DEVICE GUIDEWIRE USED? UNKNOWN. GUIDE CATHETER USED? YES. ABLE TO USE THE DEVICE BALLOON CATHETER USED? YES. ABLE TO USE THE DEVICE STENT USED? UNKNOWN. INFLATION DEVICE USED? YES. ABLE TO USE THE DEVICE IMAGING CATHETER? UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16056836 ↗