Turbo-Elite Laser Atherectomy Catheter 420-006Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00813132024758), received between Nov 6, 2018 and Oct 17, 2025 — classified as 8 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Material Separation” (6 reports).

2 FDA recall records name this device's identifier, 2 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for the marker band detaching from the distal tip of the catheter and remaining in the patient as laser catheter was retracted.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 ↗

2. Nov 15, 2023Class IIOpen, Classified

   Incorrect product labeling. Exterior product box label does not match internal pouch label.

   Z-0509-2024 · Root cause: Packaging process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 17, 2025Entrapment of Device; Entrapment of Device

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). A SPECTRANETICS TURBO-ELITE LASER ATHERECTOMY CATHETER, ALONG WITH A NON-PHILIPS GUIDEWIRE AND NON-PHILIPS INTRODUCER SHEATH, WERE USED TO TREAT THE PATIENT. DURING USE, THE TURBO-ELITE BECAME STUCK IN THE INTRODUCER SHEATH; THEREFORE, THE TURBO-ELITE AND INTRODUCER SHEATH WERE REMOVED TOGETHER. A NEW TURBO-ELITE AND INTRODUCER SHEATH WERE USED, 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 23327733 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A SLIGHTLY CALCIFIED PLAQUE LESION IN THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) AND PROXIMAL POPLITEAL ARTERY. A SPECTRANETICS TURBO-ELITE LASER ATHERECTOMY CATHETER WAS USED TO TREAT THE PATIENT. AFTER TREATMENT, IMAGING SHOWED WHAT APPEARED TO BE DISLODGED PLAQUE THAT HAD EMBOLIZED. A FILTER AND BALLOON WERE PLACED TO CAPTURE THE EMBOLISM, AND THE FILTER WAS REMOVED FROM THE PATIENT. AT THIS TIME, IT WAS NOTICED THAT THERE WAS FURTHER EMBOLIZATION IN THE TIBIOPERONEAL (TP) TRUNK; THEREFORE, A MEDTRONIC SPIDERFX EMBOLIC PROTECTION DEVICE WAS USED TO CAPTURE AND REMOVE THE EMBOLISM. ONCE REMOVED, THE TP VESSELS WERE FILLING PROPERLY. HOWEVER, LATER THAT WEEK, THE PATIENT RETURNED FOR FOLLOW-UP, AND ULTRASOUND DETECTED THAT THE PATIENT HAD RE-OCCLUSION, WHICH WAS LARGER THAN THE ORIGINAL TREATMENT SITE. THE PEDAL VESSELS WERE SHOWING VERY LITTLE BLOOD FLOW; THUS, A STENT WAS PLACED, AND THE PATIENT WAS SCHEDULED FOR SURGERY AT A LATER DATE. THIS REPORT CAPTURES THE TURBO-ELITE IN USE IN THE AREA WHERE AN EMBOLISM AND RE-OCCLUSION OCCURRED, REQUIRING INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION OF ANY SPECTRANETICS DEVICES IN

  Patient problems: Embolism/Embolus; Obstruction/Occlusion

  MAUDE report 22973734 ↗
• MalfunctionAug 18, 2025Material Separation; Material Separation

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A SEVERELY CALCIFIED LESION IN THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). A SPECTRANETICS TURBO-ELITE LASER ATHERECTOMY CATHETER WAS USED TO TREAT THE PATIENT. WHILE LASING THROUGH THE LESION, RESISTANCE WAS ENCOUNTERED, AND A CRACK JUST BEYOND THE FLUSH PORT WAS OBSERVED, WITH RED LASER LIGHT EMITTING. THE TURBO-ELITE WAS REMOVED AND A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED. THIS EVENT IS BEING REPORTED FOR UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 22834161 ↗
• MalfunctionJul 7, 2025Material Separation; Material Separation

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A SEVERELY CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). A SPECTRANETICS TURBO-ELITE LASER ATHERECTOMY CATHETER WAS USED TO TREAT THE PATIENT. DURING USE, THE DISTAL TIP OF THE CATHETER APPEARED CHARRED; THEREFORE, THE DEVICE WAS REMOVED, AND THE CASE WAS ABORTED WITH NO REPORTED PATIENT HARM. THE PATIENT WILL BE SCHEDULED TO HAVE BYPASS DUE TO PATIENT CONDITION (SEVERE CTO). UPON DEVICE EVALUATION ON (B)(6) 2025, VISUAL INSPECTION OF THE TURBO-ELITE FOUND MISSING AND CHARRED EPOXY, WITH CHIPPED FIBERS AT THE DISTAL TIP. THIS REPORT CAPTURES THE TURBO-ELITE WITH MISSING MATERIAL, POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22421422 ↗
• InjuryNov 1, 2024Material Separation; Material Separation

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A FIBROUS LESION IN THE MID SUPERFICIAL FEMORAL ARTERY (SFA). AFTER TREATMENT WITH A SPECTRANETICS TURBO-ELITE LASER ATHERECTOMY CATHETER, IT WAS DISCOVERED THE DISTAL MARKER BAND HAD SEPARATED WITHIN THE PATIENT. A WIRE AND BALLOON WERE USED TO SUCCESSFULLY REMOVE THE MARKER BAND. THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT HARM. THIS REPORT CAPTURES THE TURBO-ELITE DISTAL MARKER BAND WHICH SEPARATED, REQUIRING INTERVENTION FOR RETRIEVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20585107 ↗
• InjuryDec 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A SLIGHTLY CALCIFIED PLAQUE LESION IN THE MID SUPERFICIAL FEMORAL ARTERY (SFA). A SPECTRANETICS TURBO-ELITE LASER ATHERECTOMY CATHETER WAS USED TO TREAT THE PATIENT. AFTER THE ATHERECTOMY WAS COMPLETED, IT WAS DISCOVERED THAT A CLOT HAD EMBOLIZED DISTALLY INTO THE PATIENT'S TIBIAL ARTERIES. TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS ADMINISTERED TO DISSOLVE THE CLOT, AND THE PATIENT SURVIVED THE PROCEDURE. THIS REPORT CAPTURES THE TURBO-ELITE IN USE WHEN AN EMBOLISM OCCURRED, REQUIRING INTERVENTION. THERE WAS NO ALLEGED MALFUNCTION OF THE TURBO-ELITE DEVICE IN USE DURING THE PROCEDURE.

  Patient problems: Embolism/Embolus

  MAUDE report 18271017 ↗
• MalfunctionAug 16, 2023Material Separation; Material Separation

  ADDITIONAL INFORMATION: THE PROCEDURE WAS PERFORMED TO TREAT A MODERATELY CALCIFIED, FIBROUS LESION IN THE MID SUPERFICIAL FEMORAL ARTERY (SFA). IN ADDITION, PROPER FLUSHING TECHNIQUE WAS PERFORMED DURING THE PROCEDURE.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 17557740 ↗
• InjuryJul 6, 2023Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A MODERATELY CALCIFIED PLAQUE LESION IN THE MID SUPERFICIAL FEMORAL ARTERY (SFA). THE PHYSICIAN CHOSE A SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER TO TREAT THE PATIENT. WHILE IN USE, THE DISTAL MARKER BAND DETACHED, BUT WAS SUCCESSFULLY RETRIEVED USING A SMALL 3.0 BALLOON. PER REPORT, THE PHYSICIAN DID NOT LASE IN CONTRAST. OTHER BALLOONS WERE USED TO COMPLETE THE PROCEDURE WITH NO REPORTED PATIENT HARM. THIS EVENT CAPTURES THE TURBO ELITE'S DISTAL MARKER BAND WHICH DETACHED, REQUIRING INTERVENTION FOR RETRIEVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17273517 ↗
• InjuryJul 6, 2023Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A SLIGHTLY CALCIFIED, PLAQUE LESION IN THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). A SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER WAS USED TO TREAT THE PATIENT. AFTER THE FIRST PASS WAS COMPLETED THROUGH THE LESION, THE DEVICE WAS PULLED BACK, AND IT WAS DISCOVERED THAT THE DISTAL MARKER BAND HAD DETACHED. THE MARKER BAND WAS SUCCESSFULLY RETRIEVED USING A COOK MEDICAL 3 MM BALLOON WITH NO REPORTED PATIENT HARM. THIS EVENT CAPTURES THE TURBO ELITE'S DISTAL MARKER BAND WHICH DETACHED, REQUIRING INTERVENTION FOR RETRIEVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17273234 ↗
• MalfunctionApr 12, 2022Break; Break

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A LESION IN THE PATIENT''S MID SUPERFICIAL FEMORAL ARTERY (SFA). THE PHYSICIAN CHOSE A SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER TO TREAT THE PATIENT. DURING PREPARATION FOR USE, THE TECHNICIAN WAS CALIBRATING THE CATHETER AND NOTICED A RED LIGHT ON THE SIDE OF THE DEVICE''S TIP. A NEW TURBO ELITE DEVICE OF THE SAME MODEL WAS USED, AND THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT HARM. THIS EVENT IS BEING REPORTED FOR UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 14087707 ↗
• MalfunctionJan 21, 2022Material Puncture/Hole; Material Puncture/Hole

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A LESION IN THE PATIENT''S SUPERFICIAL FEMORAL ARTERY (SFA). A SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER WAS USED TO TREAT THE PATIENT. DURING THE PROCEDURE, A PINHOLE WAS OBSERVED APPROXIMATELY 3 CM AWAY FROM THE LUER HUB, WHERE THE DEVICE FLUSH PORT IS LOCATED. LASER LIGHT WAS VISIBLE SHINING THROUGH THE HOLE. THE DEVICE WAS USED TO FINISH THE PROCEDURE WITH NO REPORTED HARM TO THE PATIENT. THIS EVENT IS BEING REPORTED FOR UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 13318296 ↗
• InjuryOct 25, 2021Material Puncture/Hole; Detachment of Device or Device Component; Material Deformation; Material Puncture/Hole; Detachment of Device or Device Component; Material Deformation

  A PERIPHERAL PROCEDURE COMMENCED TO TREAT AN IN-STENT RESTENOSIS (ISR) IN THE MID LEFT COMMON ILIAC VEIN. THE PHYSICIAN CHOSE TO USE A SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER TO TREAT THE PATIENT, AND WAS AWARE THAT USE OF THE DEVICE WITHIN THE VENOUS SYSTEM IS CURRENTLY NOT AN INDICATION FOR USE. WHILE IN USE, THE DEVICE'S DISTAL MARKER BAND DETACHED INSIDE THE PATIENT'S VESSEL. THE MARKER BAND WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT WITH A WIRE AND BALLOON. THE PROCEDURE WAS COMPLETED USING A SECOND DEVICE WITH NO REPORTED PATIENT HARM. DURING INITIAL DEVICE EVALUATION, A BREACH TO THE DEVICE'S OUTER JACKET WAS DISCOVERED. THIS REPORT IS TO CAPTURE THE TURBO ELITE DEVICE WHEN ITS MARKER BAND DETACHED WITHIN THE PATIENT, REQUIRING INTERVENTION, AND INADVERTENT RADIATION EXPOSURE.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 12694532 ↗
• InjuryMay 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO PHILIPS (B)(6) ON (B)(6) 2021 THAT A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED ON (B)(6) 2021 TO TREAT A SLIGHTLY CALCIFIED IN STENT OCCLUSION OF THE PATIENT''S SUPERFICIAL FEMORAL ARTERY (SFA). THIS EVENT WAS REPORTED AS PART OF A POSTMARKET STUDY IN (B)(6). THE PHYSICIAN CHOSE A SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER TO TREAT THE LESION, PROXIMAL TO DISTAL. ACCORDING TO THE REPORT, AFTER THE TURBO ELITE DEVICE WAS USED, AN ARTERIAL NON FLOW LIMITING DISSECTION (GRADE C) WAS CONFIRMED, OUTSIDE OF AND PROXIMAL TO THE STENT. A PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED, BUT DISSECTION WAS CONFIRMED AFTER POBA AS WELL. AFTERWARD, IT WAS REPORTED "NO PARTICULAR BAILOUT WAS PERFORMED". THE PROCEDURE WAS COMPLETED, AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2021 WITH NO ADVERSE EVENT BEING REPORTED. THERE WAS NO ALLEGED MALFUNCTION OF THE TURBO ELITE DEVICE USED IN THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 11826323 ↗
• MalfunctionMar 4, 2021Break; Break

  PRIOR TO THE COMMENCEMENT OF A PERIPHERAL ATHERECTOMY PROCEDURE, A SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER WAS BEING CALIBRATED DURING PREPARATION FOR USE. ACCORDING TO THE REPORT, A PINHOLE AREA, APPROXIMATELY 2 INCHES FROM THE TIP OF THE DEVICE WAS OBSERVED WITH LIGHT COMING FROM THE HOLE. IT WAS REPORTED THAT THE DEVICE WAS REMOVED FROM THE PACKAGING JUST PRIOR TO ATTEMPT TO CALIBRATE. ANOTHER DEVICE WAS OPENED AND SUCCESSFULLY USED TO TREAT THE PATIENT. THIS EVENT IS BEING REPORTED DUE TO THE POTENTIAL FOR EXPOSURE TO MANUFACTURING MATERIALS AS WELL AS INADVERTENT EXPOSURE TO LASER ENERGY/RADIATION. THE TURBO ELITE DEVICE WAS DISCARDED SO DEVICE EVALUATION WILL NOT BE COMPLETED.

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 11416384 ↗
• MalfunctionNov 6, 2020Break; Break

  IT WAS REPORTED ON (B)(6) 2020 TO A PHILIPS REPRESENTATIVE THAT A PERIPHERAL VASCULAR PROCEDURE COMMENCED ON (B)(6) 2020 TO TREAT A CHRONIC TOTAL OCCLUSION (CTO) OF THE PATIENT'S MID SUPERFICIAL FEMORAL ARTERY. THE PHYSICIAN CHOSE TO USE A SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER TO TREAT THE PATIENT. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED USING THE TURBO ELITE DEVICE; HOWEVER, IT WAS ALSO REPORTED THAT THE CASING OF THE CATHETER WAS DESTROYED DURING USE (NO FURTHER DETAIL WAS PROVIDED, AND THE PHILIPS REPRESENTATIVE REPORTING THE EVENT DID NOT ATTEND THE PROCEDURE). UPON RETURN OF THE DEVICE TO THE MANUFACTURER AND SUBSEQUENT EVALUATION THAT TOOK PLACE ON (B)(6) 2020, THE TEAM DISCOVERED A BREACH TO THE DEVICE'S OUTER JACKET, MAKING IT A REPORTABLE EVENT DUE TO THE POTENTIAL FOR EXPOSURE TO MANUFACTURING MATERIALS AS WELL AS INADVERTENT EXPOSURE TO LASER ENERGY/RADIATION. THE PATIENT SURVIVED THE PROCEDURE AND THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 10800968 ↗
• MalfunctionSep 2, 2020Material Deformation; Material Deformation

  A PERIPHERAL LASER ATHERECTOMY PROCEDURE COMMENCED (ADDITIONAL CASE DETAIL REQUESTED, BUT UNAVAILABLE). A SPECTRANETICS TURBO ELITE ATHERECTOMY CATHETER WAS BEING USED TO TARGET A LESION. THEY PHYSICIAN REPORTED DIFFICULTY AND REPORTED A "SOFT SPOT" AND BENDING IN THE CATHETER. ANOTHER DEVICE WAS USED WITHOUT ISSUE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO REPORTED PATIENT HARM. HOWEVER, AFTER THE DEVICE WAS RETURNED TO THE MANUFACTURER AND EVALUATED ON 10 AUGUST 2020, IT WAS DISCOVERED THAT THE DEVICE'S OUTER JACKET SHOWED EXPOSED FIBERS. DUE TO THIS DISCOVERY, 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 10482458 ↗
• MalfunctionMar 23, 2020Crack; Crack

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED USING A SPECTRANETICS TURBO ELITE DEVICE. PROCEDURE INDICATION IS UNAVAILABLE FROM THE FACILITY. DURING USE OF THE TURBO ELITE DEVICE THE PHYSICIAN REPORTED THAT THE DEVICE HAD A SMALL CRACK IN THE DEVICES WORKING LENGTH. THE PHYSICIAN ALSO NOTICED A RED LIGHT COMING OUT OF THE DEVICE WHERE THAT CRACK IN THE DEVICE WAS LOCATED. A NEW TURBO ELITE WAS USED TO COMPLETE THE LASER ATHERECTOMY WITHOUT ANY FURTHER ISSUES. THE PATIENT WAS SUCCESSFULLY TREATED WITHOUT ANY REPORTED INJURY. THIS EVENT IS BEING REPORTED DUE TO THE POTENTIAL FOR EXPOSURE TO MANUFACTURE MATERIALS AND INADVERTENT LASER ENERGY/RADIATION EXPOSURE.

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 9869341 ↗
• MalfunctionNov 22, 2019Temperature Problem; Temperature Problem

  A PERIPHERAL VASCULAR INTERVENTION COMMENCED TO TREAT A LESION IN THE PATIENT'S SUPERFICIAL FEMORAL ARTERY (SFA). DURING USE OF THE SPECTRANETICS TURBO ELITE DEVICE, IT WAS REPORTED THAT THE PHYSICIAN FELT A SENSATION WHICH FELT WARM THROUGH HIS GLOVE. HE EXPRESSED DISCOMFORT IN HIS FINGER. THE LOCATION OF THIS OCCURRENCE WAS REPORTEDLY WHERE THE PHYSICIAN'S FINGERS WERE PLACED WHILE THE DEVICE WAS IN USE, OUTSIDE OF THE PATIENT'S BODY. IT WAS BELIEVED THAT THE PHYSICIAN'S GLOVE REMAINED INTACT, AND IT WAS REPORTED THAT NO FIRST AID OR INTERVENTION WAS REQUIRED FOR THIS AREA ON THE PHYSICIAN'S FINGER. THE PROCEDURE WAS COMPLETED WITH THE DEVICE AND THE PATIENT SURVIVED THE PROCEDURE. IN ADDITION, DUE TO THE DESCRIPTION OF THE EVENT REPORTED TO THE MANUFACTURER, THIS EVENT IS BEING REPORTED DUE TO THE POTENTIAL FOR EXPOSURE TO MANUFACTURING MATERIALS AS WELL AS INADVERTENT EXPOSURE TO LASER ENERGY/RADIATION, IN THE EVENT THAT THE DEVICE WAS BROKEN. THE MANUFACTURER IS ANTICIPATING THE RETURN OF THE DEVICE FOR EVALUATION BUT HAS NOT YET ARRIVED AT THE MANUFACTURER.

  Patient problems: Burning Sensation; Radiation Exposure, Unintended

  MAUDE report 9366094 ↗
• InjuryNov 6, 2018Radiation Leak; Material Perforation; Radiation Leak; Material Perforation

  A PHILIPS VASCULAR INTERVENTION REPRESENTATIVE REPORTED THAT DURING A PERIPHERAL ATHERECTOMY PROCEDURE, THE SPECTRANETICS TURBO-ELITE ATHERECTOMY LASER CATHETER 420-006 GOT HOT AND BURNED THROUGH THE PHYSICIAN'S GLOVES, BURNING HIS RIGHT HAND. HE FELT THIS OCCUR AS HE ADVANCED THE CATHETER AFTER THE LAST PASS (2ND PASS). THE ONLY INTERVENTION NEEDED WAS CHANGING HIS GLOVES (AS THE CATHETER HAD BURNED THROUGH THEM) AND RUNNING HIS HAND UNDER COLD WATER. THIS ISSUE DID NOT AFFECT HIS ABILITY TO FINISH THE PROCEDURE OR PERFORM ANY OTHERS. IT WAS REPORTED THAT A BREACH WAS SEEN IN THE CATHETER JACKET. 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: Burn(s); Radiation Exposure, Unintended; Superficial (First Degree) Burn

  MAUDE report 8043943 ↗