THRUWAY™ M001492981Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729717195), received between May 13, 2021 and Jan 9, 2024 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2024Entrapment of Device; Entrapment of Device

  EVENT DESCRIPTION: THE THRUWAY 014 WIRE WAS PLACED INTO THE PATIENT. THE IVUS WAS LOADED ONTO THE WIRE. AS THE IVUS WAS TURNED ON AND WORKING, PART WAY THROUGH THE IVUS WRAPPED ITSELF ONTO THE WIRE AS IT WAS SPINNING AND STOPPED WORKING. THE WIRE AND IVUS HAD TO COME OUT OF THE PATIENT AS A WHOLE. THE CASE WAS COMPLETED SUCCESSFULLY WITHOUT THE NEED OF ANOTHER IVUS CATHETER OR THRUWAY WIRE. WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: NOTHING, YOU COULD SEE ON THE FLOURO IMAGE THAT THAT IVUS HAD WRAPPED UP THE WIRE AND IT NEEDED TO BE REMOVED. WHAT IS THE NEXT COURSE OF ACTION?: TOOK OUT THE CATHETER AND WIRE PATIENT PRESENT AT TIME OF EVENT?: YES PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18479831 ↗
• MalfunctionOct 11, 2023Break; Break

  EVENT DESCRIPTION: JETSTREAM ATHERECTOMY CASE OVER A .014 THRUWAY WIRE. THE WIRE BROKE OFF IN ORIENT AS THE JETSTREAM WAS BEING REMOVED FROM THE BODY. WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: TIP OF THE WIRE WAS SNARED WITH NO ISSUE. WHAT IS THE NEXT COURSE OF ACTION?: NEW WIRE WAS PLACED AND PROCEDURE WAS COMPLETED PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS. ADDITIONAL INFORMATION: QUESTION: WHAT DOES THE END USER BELIEVE CAUSED THE THRUWAY DEVICE TO BREAK OFF? ANSWER: HE BELIEVES THE WIRES WAS PULLED BACK AND GOT STUCK IN CALCIUM. QUESTION: APPROXIMATELY HOW FAR FROM THE DISTAL TIP OF THE THRUWAY DEVICE DID THE FRACTURE OCCUR? ANSWER: 1CM. QUESTION: WAS FLUOROSCOPY USED DURING THE PROCEDURE? ANSWER: YES. QUESTION: HOW WERE THE JETSTREAM AND THRUWAY REMOVED FROM THE PATIENT? ANSWER: THE JETSTREAM WAS REMOVED NORMALLY. THE FRACTURED TIP OF THE THRUWAY WAS SNARED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17913860 ↗
• MalfunctionOct 10, 2023Entrapment of Device; Entrapment of Device

  THE JETSTREAM DEVICE STOPPED WORKING INSIDE THE RIGHT SUPERFICIAL FEMORAL ARTERY. THE CORD REMAINED ATTACHED TO THE ATHEROTOME WITH NO POSSIBILITY OF UNCOUPLING IT INSIDE THE PATIENT. AT THAT MOMENT, THE TECHNICIAN PROVIDED A SECOND DEVICE AND CORD, SINCE IT WAS NOT POSSIBLE TO UNCOUPLE THE PREVIOUS ONE INSIDE THE PATIENT. QUESTION: HOW WERE THE DEVICES REMOVED FROM THE PATIENT? ANSWER: THEY WERE REMOVED WITH THE USUAL TECHNIQUE USED FOR THIS TYPE OF CASES. QUESTION: WAS THE GUIDEWIRE ABLE TO BE REMOVED FROM THE JETSTREAM CATHETER UPON REMOVAL FROM THE PATIENT? ANSWER: THE GUIDEWIRE COULD NOT BE REMOVED, AS IT WAS STUCK INSIDE THE ATHERECTOMY DEVICE. QUESTION: WAS THERE ANY DAMAGE NOTED TO THE GUIDEWIRE AND/OR CATHETER PRIOR TO OR AFTER THE PROCEDURE? ANSWER: NO DAMAGE TO THE GUIDEWIRE OR CATHETER COULD BE OBSERVED WITH THE NAKED EYE. THE DEVICE STOPPED ABRUPTLY, LOSING THE ABILITY TO ROTATE. ROTATION WAS ATTEMPTED SEVERAL TIMES, WITHOUT SUCCESS. QUESTION: WHAT DOES THE END USER BELIEVE CAUSED THE JETSTREAM AND THRUWAY DEVICE TO BECOME STUCK TOGETHER? ANSWER: DEVICE FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17908527 ↗
• MalfunctionOct 5, 2023Entrapment of Device; Entrapment of Device

  THE PHYSICIAN ADVANCED THE THRUWAY GUIDEWIRE TO THE PEDICLE ARTERY VERY DISTAL TO THE ATHERECTOMY TREATMENT ZONE. AFTER PURGING THE JETSTREAM DEVICE, HE PROCEEDS TO ADVANCE IT OVER THE THRUWAY GUIDEWIRE WITHOUT DIFFICULTY. ONCE THE ATHERECTOMY THERAPY STARTS, ADVANCE THE DEVICE FOR 2 MINUTES, WHEN RETRACTING IT WITH THE REX FUNCTION, IT IS EVIDENT THAT THE GUIDEWIRE IS COMPLETELY RETURNED WITH THE ATHEROTOME, IT DOES NOT SLIDE. THE ENTIRE SYSTEM HAD TO BE REMOVED AND TOO MUCH TRACTION FORCE HAD TO BE USED TO EXTRACT THE GUIDEWIRE FROM THE JETSTREAM. WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: THE GUIDE WAS REMOVED AND THE DEVICE WAS PURGED TWICE. A NEW GUIDE WAS PASSED. PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS. QUESTION: WAS THE DEVICE REMOVED FROM THE PATIENT INTACT? ANSWER: YES. QUESTION: WAS THE GUIDEWIRE ABLE TO BE REMOVED FROM THE DEVICE ONCE OUTSIDE THE PATIENT? ANSWER: YES, WITH CONSIDERABLE FORCE. QUESTION: WAS THERE ANY VISIBLE DAMAGE TO THE DEVICE? IF YES, PLEASE DESCRIBE: ANSWER: NO. QUESTION: WAS THE GUIDEWIRE ENTRAPPED WITHIN THE ANATOMY OR OTHER DEVICE? PROVIDE DEVICE DETAILS IF WITHIN ANOTHER DEVICE. ANSWER: THE GUIDE WAS STUCK INSIDE A JETSTREAM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17881636 ↗
• MalfunctionFeb 10, 2023Break; Break

  EVENT DESCRIPTION: PHYSICIAN WAS PERFORMING JETSTREAM ARTHERECTOMY ON THE PATIENT USING THE THRUWAY 0.014 WIRE LONG TAPER. I WAS ADVISING THE PHYSICIAN TO BE CARE AS HE APPROACHED THE DISTAL TIP OF THE WIRE, BUT IT SEEMS IT WAS TOO LATE AND THE TIP ATTACHMENT TO THE WIRE WAS DAMAGED BUT UNNOTICEABLE. WE THEN MOVED INTO ANOTHER VESSEL TO USE THE JETSTREAM, ON PLACING THE WIRE IN THE VESSEL THEN ADVANCING THE CATHETER, THE PHYSICIAN NOTICED THE TIP OF THE WIRE HAD BROKEN OFF. I DISCUSSED WITH HIM WHAT HIS INTENTIONS WERE TO RETRIEVE THE TIP OF THE WIRE, BUT HE ADVISED THAT IT WAS NOT PROBLEMATIC TO LEAVE IT THERE AS LONG AS IT DID NO OBSTRUCT A MAIN VESSEL. THE PATIENT WAS ALSO SET TO HAVE AN AMPUTATION OF THE FOOT BEING TREATED. WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: NO STEP TAKEN TO REMOVE BROKEN TIP. WHAT IS THE NEXT COURSE OF ACTION?: NOTHING WAS DONE. PATIENT PRESENT AT TIME OF EVENT?: YES. PATIENT COMPLICATION'S: NO PATIENT COMPLICATIONS. IN THE PHYSICIAN'S OPINION, DID THE DEVICE OR PROCEDURE CAUSE OR CONTRIBUTE TO THE PATIENT COMPLICATION?: NO. PATIENT ADMITTED TO HOSPITAL BEYOND THE STANDARD OF CARE: YES. PATIENT DISCHARGED FROM HOSPITAL? YES. DISCHARGE DAT

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 16356453 ↗
• InjuryJan 10, 2023Break; Break

  EVENT DESCRIPTION: PATIENT WITH CALCIFIC OCCLUSIONS FROM THE FEMOROPOPLITEAL SEGMENT TO THE POSTERIOR TIBIAL ARTERY, THE PHYSICIAN ADVANCES A ZIPWIRE HYDROPHILIC GUIDEWIRE AND THEN A RUBICON 35 CROSSING CATHETER TO THE DISTAL SEGMENT OF THE POSTERIOR TIBIAL ARTERY. THE GUIDE IS EXCHANGED FOR THRUWAY 0.014 X 300CM LONG TAPER, THEN JETSTREAM XC 2.1/3.0MM ATHEROTOME IS ADVANCED, INITIATING ATHERECTOMY FROM THE FEMOROPOPLITEAL SEGMENT TO THE PROXIMAL THIRD OF THE POSTERIOR TIBIAL ARTERY. WHEN REMOVING THE JETSTREAM CATHETER, THE GUIDEWIRE IS OBSERVED STUCK TO THE CATHETER, THE GUIDEWIRE IS REMOVED TOGETHER WITH THE JETSTREAM DEVICE WITH RUPTURE OF THE FLOPPY TIP OF THE GUIDEWIRE THAT EMBOLIZES IN THE DISTAL SEGMENT. WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE?: PHYSICIAN ATTEMPTED TO RETRIEVE EMBOLIZED GUIDEWIRE, HOWEVER THE INSTITUTION DID NOT HAVE A RETRIEVAL DEVICE. WHAT IS THE NEXT COURSE OF ACTION?: FOLLOW-UP OF THE PATIENT'S EVOLUTION, COMPLEMENTARY EXAMINATIONS CT. PATIENT PRESENT AT TIME OF EVENT?: YES PATIENT COMPLICATIONS: VESSEL OCCLUSION IN THE PHYSICIAN'S OPINION, DID THE DEVICE OR PROCEDURE CAUSE OR CONTRIBUTE TO THE PATIENT COMPLICATION?: YES PLEASE DESCRIBE T

  Patient problems: Device Embedded In Tissue or Plaque; Embolism/Embolus

  MAUDE report 16132059 ↗
• MalfunctionSep 13, 2022Break; Break

  EVENT DESCRIPTION: WHILE REMOVING THE JETSTREAM THEY NOTICED THE WIRE HAD BE FRACTURED INSIDE THE PATIENT. A SNARE WAS USED TO REMOVE THE FRACTURED PIECE. A DIFFERENT DEVICE (SAME MODEL) WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15410952 ↗
• MalfunctionMay 27, 2021Entrapment of Device; Entrapment of Device

  AS THEY WERE COMING OUT THE JETSTREAM UNIT GOT STUCK ON THE WIRE. HAD TO PULL BOTH OUT AND LOSE ACCESS. ENDED UP OPENING A NEW THRUWAY BUT COULDN'T GET BACK INTO VESSEL SO BALLOONED ANOTHER VESSEL. AFTER THE CASE, THE SCRUB TECH SAID AS THEY WERE LOADING THE WIRE JUMPED BACK AFTER GOING THROUGH THE DEVICE SO HE'S THINKING IT WAS THE JETSTREAM UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11894169 ↗
• MalfunctionMay 13, 2021Entrapment of Device; Entrapment of Device

  DESCRIPTION OF EVENT: MADE ONE PASS WITH JETSTREAM CATHETER WIRE AND THE DEVICE GOT STUCK ON THE WAY I HAD TO PULL THE WIRE AND CATHETER OUT AS ONE WHOLE UNIT. THE PROCEDURE WAS COMPLETED USING ANOTHER JETSTREAM CATHETER AND THREE-WAY WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11819891 ↗