Turbo-Elite Laser Atherectomy Catheter 414-151Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00813132024710), received between Jul 9, 2018 and May 28, 2025 — classified as 3 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Material Separation” (7 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Nov 25, 2024Class IIOpen, Classified

   Due to complaints received for the marker band detaching from the distal tip of the catheter and remaining in the patient as laser catheter was retracted.

   Z-0680-2025 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2025Entrapment of Device; Entrapment of Device

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A MODERATELY CALCIFIED PLAQUE LESION IN THE MID ANTERIOR TIBIAL (AT) ARTERY. A SPECTRANETICS TURBO-ELITE LASER ATHERECTOMY CATHETER, ALONG WITH AN ASAHI GLADIUS MONGO 0.014 GUIDEWIRE, WAS USED TO TREAT THE PATIENT. AFTER A COUPLE OF PASSES, WHEN TRYING TO REMOVE THE TURBO-ELITE FROM THE GUIDEWIRE, RESISTANCE WAS NOTED. THE TURBO-ELITE WAS ABLE TO MOVE FORWARD; HOWEVER, WHEN ATTEMPTING TO RETRACT, THE GUIDE WIRE WOULD PULL BACK AS WELL. THEREFORE, A NEW GUIDEWIRE WAS PLACED NEXT TO THE TURBO-ELITE TO MAINTAIN ACCESS, AND THE TURBO-ELITE AND GUIDEWIRE WERE REMOVED AS A SYSTEM. A BALLOON WAS PLACED OVER THE NEW GUIDEWIRE, AND THE TREATMENT WAS COMPLETED. THERE WAS NO REPORTED PATIENT HARM. THIS REPORT IS BEING SUBMITTED DUE TO REMOVAL AS A SYSTEM. THERE IS POTENTIAL FOR HARM IF IT WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22098507 ↗
• MalfunctionJan 3, 2025Material Separation; Adverse Event Without Identified Device or Use Problem; Material Separation; Adverse Event Without Identified Device or Use Problem

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A PLAQUE LESION IN THE MID POSTERIOR TIBIAL (PT) ARTERY. A SPECTRANETICS TURBO-ELITE LASER ATHERECTOMY CATHETER WAS USED TO TREAT THE PATIENT. DURING CALIBRATION OF THE DEVICE, LIGHT COULD BE SEEN FROM THE OUTER JACKET; THEREFORE, THE TURBO-ELITE WAS REMOVED. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO REPORTED HARM TO THE PATIENT OR USER. THIS EVENT IS BEING REPORTED FOR UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Radiation Exposure

  MAUDE report 21072413 ↗
• MalfunctionDec 13, 2024Entrapment of Device; Entrapment of Device

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A MODERATELY CALCIFIED, PLAQUE LESION IN THE MID POSTERIOR TIBIAL (PT) ARTERY AND A PERONEAL ARTERY. A SPECTRANETICS TURBO-ELITE LASER ATHERECTOMY CATHETER, ALONG WITH A ABBOTT 0.014 SPARTACORE GUIDE WIRE, WAS USED TO TREAT THE PATIENT. AFTER A COUPLE OF PASSES WITH THE TURBO-ELITE OVER THE GUIDE WIRE, THE CATHETER BECAME STUCK ON THE WIRE. MULTIPLE ATTEMPTS WERE MADE TO REMOVE THE TURBO-ELITE FROM THE WIRE; HOWEVER, ATTEMPTS WERE UNSUCCESSFUL. THEREFORE, WITH CONSIDERABLE EFFORT, THE GUIDE WIRE WAS REMOVED INSTEAD. IN ORDER TO MAINTAIN ACCESS TO THE LESION, THE TURBO-ELITE WAS LEFT IN PLACE WITHIN THE PATIENT, AND A NEW ABBOTT 0.014 COMMAND GUIDE WIRE WAS INSERTED. ABOUT 2/3 OF THE WAY THROUGH THE TURBO-ELITE, ADVANCEMENT OF THE GUIDE WIRE TOOK CONSIDERABLE EFFORT, BUT ULTIMATELY REACHED THE TURBO-ELITE DISTAL TIP. LASING WAS COMPLETED ON THE PT ARTERY, AND WHEN TRYING TO REMOVE THE CATHETER FROM THE PATIENT, THE SAME ISSUE OCCURRED, AND THE WIRE WAS STUCK INSIDE THE DEVICE. BOTH THE TURBO-ELITE AND THE GUIDE WIRE WERE REMOVED FROM THE PATIENT, AND A NEW TURBO-ELITE AND BOSTON SCIENTIFIC 0.014 THRUWAY GUIDE WIRE WAS USED TO COM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20931379 ↗
• MalfunctionOct 1, 2024Material Separation; Material Separation

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A MODERATELY CALCIFIED, FIBROUS LESION IN THE PROXIMAL TIBIOPERONEAL (TP) TRUNK. A SPECTRANETICS TURBO-ELITE LASER ATHERECTOMY CATHETER WAS USED TO TREAT THE PATIENT. WHILE LASING, A SPLIT IN THE OUTER JACKET WAS DETECTED. THEREFORE, THE TURBO-ELITE WAS REMOVED AND A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO REPORTED PATIENT HARM. THIS EVENT IS BEING REPORTED FOR UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 20348570 ↗
• MalfunctionMay 9, 2024Material Separation; Material Deformation; Material Separation; Material Deformation

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED (INDICATION FOR PROCEDURE, LESION LOCATION UNK). A SPECTRANETICS TURBO-ELITE LASER ATHERECTOMY CATHETER WAS USED TO TREAT THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE TURBO-ELITE DEVICE; HOWEVER, UPON INSPECTION, FIBERS WERE VISIBLE IN THE MID-PROXIMAL PORTION OF THE CATHETER. THERE WAS NO REPORTED PATIENT HARM. THIS EVENT IS BEING REPORTED FOR UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Radiation Exposure

  MAUDE report 19282397 ↗
• MalfunctionMay 9, 2024Material Separation; Material Separation

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). A SPECTRANETICS TURBO-ELITE LASER ATHERECTOMY CATHETER WAS USED TO TREAT THE PATIENT. WHEN THE TURBO-ELITE WAS PLUGGED INTO THE LASER SYSTEM DURING PREPARATION FOR USE, HOLES WERE OBSERVED IN THE OUTER JACKET, WITH LASER LIGHT BEING EMITTED FROM THE AREAS. USE OF THE CATHETER WAS DISCONTINUED, AND ANOTHER TURBO-ELITE OF THE SAME SIZE WAS USED TO COMPLETE THE PROCEDURE WITH NO REPORTED PATIENT HARM. THIS EVENT IS BEING REPORTED FOR UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 19281862 ↗
• InjuryMar 28, 2024Material Separation; Material Separation

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A SEVERELY CALCIFIED LESION IN THE MID POPLITEAL REGION. A SPECTRANETICS TURBO-ELITE LASER ATHERECTOMY CATHETER WAS USED TO TREAT THE PATIENT. THREE PASSES WERE MADE THROUGH THE POPLITEAL REGION SUCCESSFULLY. THEN, ONE PASS WAS ATTEMPTED IN A TIBIAL ARTERY WHEN THE TURBO-ELITE COULD NOT BE ADVANCED WITHIN THE VASCULATURE. DURING REMOVAL, IT WAS OBSERVED THAT THE DISTAL MARKER BAND HAD DETACHED WITHIN THE PATIENT. A BALLOON WAS USED TO RETRIEVE THE MARKER BAND, AND A BALLOON ANGIOPLASTY WAS PERFORMED TO COMPLETE THE CASE. THE PATIENT SURVIVED THE PROCEDURE. THIS EVENT CAPTURES THE TURBO ELITE DISTAL MARKER BAND WHICH SEPARATED, REQUIRING INTERVENTION FOR RETRIEVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18997538 ↗
• MalfunctionMay 18, 2023Break; Material Separation; Break; Material Separation

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT CRITICAL LIMB ISCHEMIA DUE TO A MODERATELY FIBROUS LESION IN THE DISTAL POSTERIOR TIBIAL (PT) ARTERY. A SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER WAS USED TO TREAT THE PATIENT. DURING THE PROCEDURE, RED LIGHT WAS OBSERVED COMING THROUGH THE OUTER JACKET. USE OF THE DEVICE WAS DISCONTINUED AND ANOTHER CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH NO REPORTED PATIENT HARM. THIS EVENT IS BEING REPORTED FOR UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Radiation Exposure

  MAUDE report 16956939 ↗
• MalfunctionMay 11, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A MODERATELY CALCIFIED PLAQUE LESION IN THE PATIENT''S DISTAL POSTERIOR TIBIAL (PT) ARTERY. THE PHYSICIAN CHOSE TO USE A SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER TO TREAT THE PATIENT. DURING THE PROCEDURE, THE TURBO ELITE''S OUTER JACKET BECAME COMPROMISED DURING ADVANCEMENT ACROSS THE LESION, AND LASER LIGHT COULD BE OBSERVED COMING OUT OF THE SIDE OF THE CATHETER. USE OF THE TURBO ELITE WAS DISCONTINUED, AND ANOTHER ONE WAS OPENED TO COMPLETE THE PROCEDURE WITH NO REPORTED PATIENT HARM. THIS EVENT IS BEING REPORTED FOR UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Radiation Exposure

  MAUDE report 14366115 ↗
• MalfunctionMar 23, 2022Melted; Melted

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A SEVERELY CALCIFIED LESION IN THE PATIENT''S PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). THE PHYSICIAN CHOSE A SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER TO TREAT THE PATIENT. DURING THE PROCEDURE, THE CATHETER STARTED SMOKING; THE GUIDE WIRE BECAME STUCK IN THE TURBO ELITE CATHETER AS WELL AND THE ENTIRE SYSTEM WAS REMOVED. IT WAS NOTED THAT THE THE DEVICE''S TIP HAD MELTED. THE CASE WAS ABORTED, AND THE PATIENT HAS BEEN SCHEDULED LATER TO ATTEMPT A RETROGRADE POPLITEAL APPROACH. THERE WAS NO REPORTED PATIENT HARM. THIS REPORT CAPTURES THE TURBO ELITE DEVICE WHICH WAS DAMAGED DURING THE PROCEDURE, CAUSING UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 13865966 ↗
• MalfunctionNov 1, 2021Material Separation; Material Deformation; Material Separation; Material Deformation

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A MODERATELY CALCIFIED LESION IN THE MID POSTERIOR TIBIAL (PT) ARTERY. THE PHYSICIAN CHOSE A SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER TO TREAT THE PATIENT. IT WAS REPORTED THAT THE TURBO ELITE DEVICE COULD NOT CROSS THE LESION. WHEN THE DEVICE WAS REMOVED FROM THE PATIENT, THEY NOTICED THE BACK END OF THE CATHETER WAS MELTED AND FIBERS EXPOSED. PHOTO RETURNED TO THE MANUFACTURER CONFIRMED THE REPORT. A .9 TURBO ELITE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO REPORTED PATIENT HARM. BASED ON THE PHOTOS PROVIDED, THIS EVENT IS BEING REPORTED FOR UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 12733605 ↗
• InjuryOct 13, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  A PHILIPS REPRESENTATIVE BECAME AWARE THAT A PROCEDURE IN WHICH A SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER WAS IN USE (INDICATION AND LOCATION OF PROCEDURE UNK). DURING USE WITHIN THE PATIENT, THE DEVICE'S DISTAL MARKER BAND DETACHED INSIDE THE PATIENT. THE PHYSICIAN WAS ABLE TO RETRIEVE THE MARKER BAND USING A FILTER WIRE, AND THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT HARM. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE NOT BEEN SUCCESSFUL. THIS REPORT CAPTURES THE TURBO ELITE DEVICE IN USE WHEN THE MARKER BAND DETACHED WITHIN THE PATIENT, REQUIRING INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12627252 ↗
• MalfunctionJul 21, 2021Break; Break

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A SEVERELY CALCIFIED LESION IN THE PROXIMAL PERONEAL ARTERY. THE PHYSICIAN CHOSE TO USE A SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER TO TREAT THE PATIENT. ACCORDING TO THE REPORT, CALIBRATION WAS NORMAL, AND THEN AT INITIAL FLUSH OF THE DEVICE, RESISTANCE WAS FELT AND A GUIDE WIRE COULD NOT EASILY PASS THROUGH THE TURBO ELITE CATHETER. HOWEVER, ULTIMATELY IT DID WORK, AND THE PHYSICIAN LASED A SMALL PORTION WITHIN THE PERONEAL ARTERY WITHOUT TROUBLE. AFTER THE CATHETER WAS REMOVED FROM THE PATIENT, ON VISUAL INSPECTION THE TEAM SAW RED LIGHT EMITTING FROM THE CATHETER AT APPROXIMATELY ONE METER FROM THE DEVICE'S DISTAL TIP. THE REPORT STATED THAT THE CATHETER WAS PROBABLY ALREADY BROKEN BEFORE THE FIRST LASER ATTEMPT, EXPLAINING THE FLUSH AND GUIDE WIRE RESISTANCE, BUT THE TEAM DID NOT SEE THE RED LIGHT AT THAT TIME. ONCE THE RED LIGHT WAS SEEN EMITTING FROM THE CATHETER, USE OF THE DEVICE WAS DISCONTINUED AND THE PROCEDURE WAS COMPLETED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) AND ANOTHER TURBO ELITE DEVICE, USED ON LOW SETTINGS WITH NO REPORTED PATIENT HARM. THIS EVENT IS BEING REPORTED DUE TO UNINTENDED RADI

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Radiation Exposure

  MAUDE report 12207879 ↗
• MalfunctionJun 17, 2021Deformation Due to Compressive Stress; Physical Resistance/Sticking

  TURBO ELITE LASER ATHERECTOMY CATHETER WAS KINKED AND GOT STUCK TO THE WIRE WHILE INSIDE PATIENT. NO INJURY OCCURRED. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 12032342 ↗
• MalfunctionMay 25, 2021Material Deformation; Material Deformation

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A SLIGHTLY CALCIFIC, FIBROUS LESION IN THE DISTAL ANTERIOR TIBIAL ARTERY USING A CONTRALATERAL APPROACH. A SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER WAS CHOSEN TO TREAT THE PATIENT. ACCORDING TO THE REPORT, RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE TURBO ELITE DEVICE. HOWEVER, THE DEVICE WAS STILL ADVANCED TO THE LESION SITE AND TREATMENT WAS GIVEN TO THE PATIENT, WITH TWO PASSES OF THE LASER FIBER THROUGH THE LESION. WHEN THE TURBO ELITE DEVICE WAS REMOVED FROM THE PATIENT, IT WAS NOTED THAT THE DEVICE WAS KINKED AND LASER FIBERS COULD BE SEEN IN THE KINKED AREA. THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT HARM. THIS EVENT IS BEING REPORTED DUE TO THE POTENTIAL FOR EXPOSURE TO MANUFACTURING MATERIALS AS WELL AS INADVERTENT EXPOSURE TO LASER ENERGY/RADIATION. THE DEVICE WAS DISCARDED SO IT CANNOT BE DETERMINED WHAT CAUSED THE REPORTED FAILURE.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 11877489 ↗
• InjuryApr 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO A PHILIPS (B)(4) REPRESENTATIVE ON (B)(6) 2021 THAT ON (B)(6) 2020, A PERIPHERAL VASCULAR PROCEDURE WAS PERFORMED TO TREAT IN-STENT RESTENOSIS (ISR) IN THE PATIENT'S DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). THIS PROCEDURE WAS PART OF A (B)(4)POSTMARKET STUDY. TWO SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETERS WERE USED DURING THE PROCEDURE (MODELS 417-152 AND 414-151) TO TREAT THE PATIENT AND AFTER THE TURBO ELITE DEVICE (MODEL 414-151) WAS USED, AN EMBOLIZATION WAS CONFIRMED BY ANGIOGRAM. PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS THEN PERFORMED, AND A REPEAT ANGIOGRAM CONFIRMED NO FURTHER EMBOLIZATION. THE PROCEDURE WAS COMPLETED AND THE PATIENT SURVIVED. THERE WAS NO ALLEGED MALFUNCTION OF ANY SPECTRANETICS DEVICES IN USE DURING THE PROCEDURE.

  Patient problems: Embolism/Embolus

  MAUDE report 11631217 ↗
• MalfunctionMar 31, 2021Failure to Calibrate; Failure to Calibrate

  A PERIPHERAL LASER ATHERECTOMY PROCEDURE COMMENCED. PATIENT INFORMATION, INDICATION FOR PROCEDURE, TREATMENT LOCATION WAS REQUESTED BUT COULD NOT BE OBTAINED. THE PHYSICIAN, PER REPORT, CHOSE TO USE A SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER FOR THE PROCEDURE. IT WAS REPORTED THAT THE DEVICE WOULD NOT CALIBRATE DURING PREPARATION FOR USE. IT WAS ALSO REPORTED THAT A SECOND DEVICE WAS USED AND THE CASE WAS COMPLETED WITH NO REPORTED PATIENT HARM. WHEN THE COMPLAINT INFORMATION WAS OBTAINED, THE LOT NUMBER OF THE DEVICE REVEALED THAT THE DEVICE WHICH WOULD NOT CALIBRATE HAD EXPIRED. THIS REPORT IS BEING CREATED DUE TO THE POTENTIAL FOR COMPLICATION IF THIS EVENT WAS TO RECUR AND THE DEVICE WOULD HAVE BEEN USED WITHIN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11595883 ↗
• MalfunctionAug 19, 2020Break; Deformation Due to Compressive Stress; Break; Deformation Due to Compressive Stress

  A PERIPHERAL LASER ATHERECTOMY PROCEDURE COMMENCED TO TREAT LESIONS IN THE DISTAL POPLITEAL ARTERY AND IN THE ANTERIAL TIBIAL (AT) ARTERY. A SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER WAS USED TO TREAT THE PATIENT. IT WAS REPORTED THAT THE LESION IN THE DISTAL POPLITEAL ARTERY WAS TREATED SUCCESSFULLY AND THE TURBO ELITE DEVICE PERFORMED AS INTENDED. THE PHYSICIAN THEN PROCEEDED TO PERFORM A LASER ATHERECTOMY IN THE LONG AT ARTERY. A SMALL KINK WAS NOTICED ON THE FAR DISTAL END OF THE GUIDE WIRE, BUT THE PHYSICIAN WAS ABLE TO COMPLETE A PASS THROUGH THE LESION AT 40/40 FLUENCE. THE PHYSICIAN REPORTEDLY PULLED THE LASER CATHETER BACK AND THEN PROCEEDED TO PERFORM ANOTHER PASS THROUGH THE LESION AT 60/60 FLUENCE. HOWEVER, WHILE LASING AND ADVANCING THE LASER CATHETER, THE PHYSICIAN HAD NOTED SOME RESISTANCE AND THEN NOTICED A KINK IN THE LASER FIBER OUTSIDE THE BODY, TOWARDS THE PROXIMAL END OF THE DEVICE. THE REP REPORTED SEEING RED LIGHT COMING OUT OF THE KINKED AREA OF THE LASER CATHETER. THE DEVICE WAS REMOVED FROM THE BODY, AND A NEW LASER CATHETER WAS USED TO SUCCESSFULLY FINISH THE CASE WITH NO REPORTED PATIENT HARM. ALTHOUGH THE TURBO ELITE DEVICE IS NOT BEING RETUR

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 10426046 ↗
• MalfunctionJan 8, 2020Break; Break

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A PLAQUE LESION IN THE RIGHT MID PERONEAL ARTERY. DURING USE OF THE SPECTRANETICS TURBO ELITE DEVICE, THE PHYSICIAN REPORTED THAT THE DEVICE WAS DIFFICULT TO ADVANCE OVER THE GUIDE WIRE BEING USED IN THE PROCEDURE. THE SCRUB TECH NOTICED LASER LIGHT COMING FROM THE SIDE OF THE TURBO ELITE DEVICE'S WORKING LENGTH. THE DEVICE WAS REMOVED AND A NEW TURBO ELITE DEVICE WAS USED TO COMPLETE THE LASER ATHERECTOMY WITHOUT ANY FURTHER ISSUES. THE PATIENT WAS SUCCESSFULLY TREATED WITH NO REPORTED INJURY. THIS EVENT IS BEING REPORTED DUE TO THE POTENTIAL FOR EXPOSURE TO MANUFACTURING MATERIALS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9564154 ↗
• MalfunctionApr 25, 2019Material Integrity Problem; Material Integrity Problem

  A VASCULAR INTERVENTION CASE COMMENCED TO TREAT THE PERIPHERAL AREA. DURING THE CASE A HYDROPHILIC BALANCE MIDDLEWEIGHT (BMW) MICROGLIDE GUIDE WIRE WAS USED WITH A SPECTRANETICS TURBO ELITE DEVICE AND OUTER SHEATH. BEFORE THE PROCEDURE BEGAN, THE PHILIPS REPRESENTATIVE ATTEMPTED TO ADVISE THE PHYSICIAN TO NOT USE THE HYDROPHILIC GUIDE WIRE WITH THE TURBO ELITE DEVICE BUT THE PHYSICIAN PROCEEDED WITH USING THE HYDROPHILIC GUIDE WIRE. DURING THE CASE THE PHYSICIAN EXPERIENCED DIFFICULTY ADVANCING THE LASER CATHETER OVER THE WIRE AND DECIDED TO REMOVE THE TURBO ELITE DEVICE FROM THE PATIENT. ONCE THE CATHETER WAS REMOVED, THE PHYSICIAN OBSERVED MELTING AND REPORTED A ''BURN'' MARK ON THE OUTER SHEATH, NEAR THE MIDDLE OF THE WORKING LENGTH. THE PHILIPS REPRESENTATIVE ALSO NOTICED A BURN MARK ON THE DISTAL TIP OF THE TURBO ELITE CATHETER. THROUGH OUT THE PROCEDURE, THE PHYSICIAN HAD FLUSHED THE CATHETER THROUGH THE INNER LUMEN BETWEEN LASER TRAINS. THE PHILIPS REPRESENTATIVE REPORTED THE GUIDE WIRE HAD NOT HAD ANY DAMAGE. THE TURBO ELITE DEVICE WAS REMOVED FROM THE PATIENT VISIBLY WHOLE AND INTACT. THE CASE WAS COMPLETED WITH ANOTHER TURBO ELITE DEVICE, AND NO PATIENT INJURY WAS REPORTE

  Patient problems: No Consequences Or Impact To Patient; Radiation Exposure, Unintended

  MAUDE report 8552910 ↗
• MalfunctionOct 28, 2018Material Puncture/Hole; Material Puncture/Hole

  A PHILIPS REPRESENTATIVE REPORTED THAT DURING INSPECTION OF A TURBO-ELITE LASER ATHERECTOMY CATHETER 414-151, PRIOR TO USE IN A PERIPHERAL ATHERECTOMY PROCEDURE, A HOLE WAS NOTED IN THE CATHETER WHEN ATTEMPTING TO CALIBRATE THE DEVICE. THE DEVICE DID NOT ENTER THE PATIENT'S BODY. ANOTHER TURBO-ELITE LASER ATHERECTOMY CATHETER 414-151 WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THIS EVENT IS BEING REPORTED DUE TO THE POTENTIAL FOR EXPOSURE TO MANUFACTURING MATERIALS AS WELL AS INADVERTENT EXPOSURE TO LASER ENERGY/RADIATION.

  Patient problems: No Known Impact Or Consequence To Patient; Radiation Exposure, Unintended

  MAUDE report 8011694 ↗
• MalfunctionJul 9, 2018Material Puncture/Hole; Material Puncture/Hole

  A VASCULAR INTERVENTION PROCEDURE COMMENCED TO TREAT AN ANTERIAL TIBIAL LESION. WHEN THE LASER CATHETER WAS PLUGGED INTO THE LASER SYSTEM, VISIBLE LASER LIGHT (AIMING LIGHT) WAS OBSERVED COMING OUT FROM AN AREA JUST DISTAL TO THE WHITE, WIRE INSERTION COUPLER. THE LASER WAS NEVER CALIBRATED, NOR WAS IT INSERTED INTO THE PATIENT. PER REPORT, IT APPEARED THAT THE DEVICE JACKET DID NOT FULLY ENCASE THE LASER BUNDLE. ANOTHER DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT HARM. ALTHOUGH THE DEVICE WAS NOT CALIBRATED IN THIS CASE, THIS EVENT IS BEING REPORTED DUE TO THE POTENTIAL WITH RECURRENCE FOR EXPOSURE TO MANUFACTURING MATERIALS AS WELL AS INADVERTENT EXPOSURE TO LASER ENERGY/RADIATION IF THE DEVICE HAD BEEN CALIBRATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7671736 ↗