Turbo-Elite Laser Atherectomy Catheter 410-152Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00813132024697), received between Aug 24, 2018 and Mar 24, 2026 — classified as 2 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Material Separation” (11 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2026Material Separation

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A PATIENT WITH USE OF A SPECTRANETICS TURBO-ELITE LASER ATHERECTOMY CATHETER. DURING USE, THE LASER BURNED THROUGH THE OUTER JACKET. THE CATHETER WAS REMOVED AND A NEW TURBO-ELITE 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 24680033 ↗
• MalfunctionOct 29, 2025Material Separation; Material Separation

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A LESION USING A SPECTRANETICS TURBO-ELITE LASER ATHERECTOMY CATHETER. DURING USE, EXPOSED FIBERS AND A COMPROMISED OUTER JACKET WERE OBSERVED. 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 23414418 ↗
• MalfunctionOct 15, 2025Material Separation; Material Separation

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A MODERATELY FIBROUS LESION IN THE MID ARTERIAL TIBIAL (AT) ARTERY. A SPECTRANETICS TURBO-ELITE LASER ATHERECTOMY CATHETER WAS USED TO TREAT THE PATIENT. DURING USE, THE CATHETER COULD NOT BE RECALIBRATED AFTER THE SECOND RUN. ANOTHER CATHETER WAS USED TO COMPLETE THE PROCEDURE WITH NO REPORTED PATIENT HARM. UPON DEVICE EVALUATION ON 18SEP2025: VISUAL INSPECTION FOUND HEAVY BIOLOGICS, CHIPPED FIBERS AND EPOXY, ALONG WITH MISSING FIBERS AND EPOXY AT THE TURBO-ELITE DISTAL TIP. ON THE PROXIMAL END OF THE CATHETER, OVER HALF OF THE FIBERS WERE NON-FUNCTIONING; THEREFORE, UNABLE TO PERFORM CALIBRATION. THIS REPORT CAPTURES THE TURBO-ELITE WITH MISSING MATERIAL; POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23305967 ↗
• MalfunctionMar 27, 2025Wrong Label; Wrong Label

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A DISTAL SOFT TISSUE LESION IN THE ANTERIOR TIBIAL (AT) ARTERY. DURING THE PROCEDURE, A SPECTRANETICS TURBO-ELITE LASER ATHERECTOMY CATHETER WAS USED, BUT THE ENERGY COULD NOT BE INCREASED AT THAT TIME, THE STAFF CHECKED THE INSIDE PACKAGING LABEL AND NOTICED A LABELING DISCREPANCY. THE INSIDE PACKAGING LABEL WAS FOR A 1.4 TURBO-ELITE, AND NOT A 0.9 TURBO ELITE (SIZE USER INTENDED TO USE), AS INDICATED ON THE BOX LABEL. THE PROCEDURE WAS COMPLETED WITH THE 1.4 TURBO-ELITE, WITH NO PATIENT INJURY REPORTED. THIS REPORT CAPTURES THE LABELING DISCREPANCY THAT A LARGER SIZE DEVICE WAS CONTAINED INSIDE THE BOX; POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21707105 ↗
• MalfunctionFeb 18, 2025Material Separation; Material Separation

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED, AND A SPECTRANETICS TURBO-ELITE LASER ATHERECTOMY CATHETER WAS USED TO TREAT THE PATIENT. WHILE ATTEMPTING TO PUSH THE TURBO-ELITE INTO THE NON-PHILIPS 6F INTRODUCER SHEATH, RESISTANCE WAS ENCOUNTERED. THE OUTER JACKET APPEARED TO HAVE A TEAR, AND RED LIGHT COULD BE SEEN ON THE SIDE OF THE JACKET. 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 21400825 ↗
• MalfunctionJan 3, 2025Material Separation; Material Separation

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED, AND A SPECTRANETICS TURBO-ELITE LASER ATHERECTOMY CATHETER WAS USED TO TREAT THE PATIENT. THERE WAS MELTING NOTED ON THE WORKING LENGTH OF THE DEVICE; THEREFORE, THE TURBO-ELITE WAS REMOVED. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO REPORTED PATIENT HARM. UPON COMPLETION OF THE TURBO-ELITE DEVICE EVALUATION ON (B)(6)2024, A WRINKLE AND A BREACH OF THE OUTER JACKET WAS DETECTED. AT THE AREA OF THE BREACH, THE OUTER JACKET WAS MELTED, WITH BROKEN FIBERS PRESENT. THIS EVENT IS BEING REPORTED FOR UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 21072183 ↗
• MalfunctionJan 12, 2024Material Separation; Material Integrity Problem; Material Separation; Material Integrity Problem

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED, AND A SPECTRANETICS TURBO-ELITE LASER ATHERECTOMY CATHETER WAS USED TO TREAT THE PATIENT. INITIAL CALIBRATION OF THE CATHETER WENT SMOOTHLY AND PERFORMED NORMALLY. UPON REMOVAL, FLAKING WAS REPORTED AT THE TIP OF THE CATHETER. USE OF THE CATHETER WAS DISCONTINUED, AND ANOTHER LASER CATHETER WAS USED TO COMPLETE THE PROCEDURE WITH NO REPORTED PATIENT HARM. DURING INITIAL DEVICE EVALUATION, A MISSING PORTION OF THE OUTER JACKET WAS NOTED, AND EXPOSED FIBERS WERE PRESENT IN THE AREA. THE EVALUATION AND INVESTIGATION ARE CURRENTLY ONGOING. THIS EVENT IS BEING REPORTED FOR UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 18504521 ↗
• MalfunctionAug 16, 2023Material Separation; Material Separation

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A MODERATELY CALCIFIED PLAQUE LESION IN THE PROXIMAL POPLITEAL ARTERY. A SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER WAS USED TO TREAT THE PATIENT. DURING USE, IT WAS REPORTED THAT THE GUIDE WIRE COULD NOT BE ADVANCED OVER THE LASER CATHETER. THE DEVICE WAS REMOVED AND A NEW LASER CATHETER WAS USED TO COMPLETE THE PROCEDURE WITH NO REPORTED PATIENT HARM. HOWEVER, UPON RETURN OF THE DEVICE FOR EVALUATION, A BREACH IN THE OUTER JACKET WAS DISCOVERED, WITH EXPOSED FIBERS IN THE AREA. THIS EVENT IS BEING REPORTED FOR UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 17558179 ↗
• MalfunctionJul 6, 2023Material Separation; Material Separation

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED, AND A SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER WAS USED TO TREAT THE PATIENT. DURING USE, THE DEVICE WAS LOADED OVER THE GUIDE WIRE, AND WHEN RETRACTED FROM THE PATIENT, DAMAGE WAS OBSERVED AT THE PROXIMAL END. PER PHOTO PROVIDED, A BREACH IN THE OUTER JACKET WITH BROKEN AND EXPOSED FIBERS WERE VISUALIZED, JUST DISTAL TO THE STRAIN RELIEF. ANOTHER TURBO ELITE 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 17273876 ↗
• MalfunctionMar 3, 2023Sharp Edges; Sharp Edges

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A SLIGHTLY CALCIFIED LESION IN THE PATIENT''S MID POSTERIOR TIBIAL (PT) ARTERY. THE PHYSICIAN CHOSE A SPECTRANETICS 0.9 TURBO ELITE LASER ATHERECTOMY CATHETER TO TREAT THE PATIENT, BUT WOULD NOT ADVANCE THROUGH THE LESION. THE DEVICE WAS REMOVED FROM THE PATIENT, AND THE CATHETER APPEARED DAMAGED OR MELTED AT THE DISTAL END. THERE WAS NO REPORTED PATIENT HARM. DURING DEVICE EVALUATION AND INVESTIGATION, PROTRUDING/SHARP EDGES WERE OBSERVED AT THE DEVICE''S DISTAL TIP. THIS EVENT CAPTURES THE TURBO ELITE WITH PROTRUDING/SHARP EDGES, POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16482857 ↗
• MalfunctionJan 4, 2023Material Separation; Material Separation

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A 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 USE, A TEAR WAS NOTED IN THE WORKING LENGTH OF THE CATHETER. THE TURBO ELITE WAS REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED USING BALLOONS AND OTHER DEVICES WITH NO REPORTED PATIENT HARM. THIS EVENT IS BEING REPORTED FOR UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 16096582 ↗
• MalfunctionJun 30, 2022Product Quality Problem; Product Quality Problem

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A PATIENT'S SEVERELY CALCIFIED POSTERIOR TIBIAL ARTERY. THE PHYSICIAN CHOSE TO USE A SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER TO TREAT THE PATIENT. DURING PREPARATION FOR USE, IT WAS REPORTED THAT HAIR WAS PRESENT INSIDE THE STERILE TRAY. HOWEVER, THE CATHETER WAS USED REGARDLESS AND THE CASE WAS COMPLETED WITH NO REPORTED PATIENT HARM. THIS REPORT CAPTURES THE TURBO ELITE IN WHICH A FOREIGN OBJECT WAS FOUND INSIDE THE STERILE TRAY, POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14880537 ↗
• MalfunctionMar 30, 2022Failure to Calibrate; Failure to Calibrate

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED, INDICATION FOR PROCEDURE/LOCATION OF PROCEDURE UNK. THE PHYSICIAN CHOSE A SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER TO TREAT THE PATIENT. IT WAS REPORTED THAT THE TURBO ELITE DEVICE DID NOT CALIBRATE, SO A SECOND TURBO ELITE DEVICE, SAME MODEL, WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH NO REPORTED PATIENT HARM. HOWEVER, DURING DEVICE EVALUATION ON 03 MAR 2022, IT WAS DISCOVERED THAT KINKS, BROKEN FIBERS AND BREACHES TO THE DEVICE'S OUTER JACKET WERE PRESENT ON THE DEVICE'S WORKING LENGTH. THIS REPORT CAPTURES THE TURBO ELITE WHICH WAS FOUND TO HAVE KINKS, BROKEN FIBERS AND BREACHES TO THE OUTER JACKET, CAUSING UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 13955823 ↗
• MalfunctionOct 25, 2021Material Puncture/Hole; Material Twisted/Bent; Material Puncture/Hole; Material Twisted/Bent

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A PLAQUE LESION IN THE MID ANTERIOR TIBIAL (AT) VESSEL. THE PHYSICIAN CHOSE TO USE A SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER TO TREAT THE PATIENT. WHEN THEY WERE GOING TO INSERT THE TURBO ELITE DEVICE FOR A SECOND RUN THROUGH THE LESION, THEY NOTICED THE TIP OF THE CATHETER WAS MELTED. ANOTHER TURBO ELITE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO REPORTED PATIENT HARM. PHOTOS OF THE RETURNED DEVICE REVEAL A BREACH IN THE DEVICE'S OUTER JACKET WITH EXPOSED, BROKEN FIBERS. BASED ON THE PHOTOS RECEIVED BY THE MANUFACTURER, THIS EVENT IS BEING REPORTED FOR UNINTENDED RADIATION EXPOSURE, POTENTIAL FOR HARM.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 12694434 ↗
• MalfunctionJul 23, 2021Break; Material Deformation; Material Split, Cut or Torn; Break; Material Deformation; Material Split, Cut or Torn

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT A LESION IN THE DISTAL TIBIAL ARTERY. THE PHYSICIAN CHOSE TO USE A SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER TO TREAT THE PATIENT. THE REPORT STATED THAT THE PHYSICIAN HAD PEDAL ACCESS TO THE LESION, AS WELL AS ACCESS FROM ABOVE. HE ADVANCED THE TURBO ELITE DEVICE FROM ABOVE WHILE HOLDING FAIRLY AGGRESSIVE BACK PRESSURE AS HE ATTEMPTED TO CROSS THE LESION. A FEW DIFFERENT SETTINGS ON THE TURBO ELITE DEVICE WERE USED TO ATTEMPT TO CROSS THE LESION, BUT WERE UNSUCCESSFUL. AS THE PHYSICIAN WAS TRYING TO ADVANCE THE LASER, THE OUTER JACKET REPORTEDLY STARTED TO WRINKLE AND IT SEEMED THE DEVICE WAS HAVING A HARD TIME TRACKING, OR POSSIBLY GETTING STUCK ON THE WIRE, WHICH WAS A 14 COMMAND WIRE. THE PHILIPS REPRESENTATIVE ADVISED THE PHYSICIAN TO STOP AND WITHDRAW THE TURBO ELITE DEVICE FROM THE PATIENT. HE WAS THEN ABLE TO CROSS THE LESION VIA BALLOON ANGIOPLASTY FROM THE PEDAL ACCESS, AND THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT HARM. THE PHYSICIAN STATED HE DIDN'T BELIEVE THE DEVICE WAS DEFECTIVE; HE STATED HE WAS JUST BEING PRETTY ROUGH WITH IT. THE PHILIPS REPRESENTATIVE STATED THAT THE CATHETER HAD WRINKLES

  Patient problems: Unintended Radiation Exposure

  MAUDE report 12217292 ↗
• MalfunctionJun 24, 2021Fracture; Fracture

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED TO TREAT THE DISTAL SEGMENT OF A SEVERELY CALCIFIED LESION IN THE PATIENT'S PERONEAL ARTERY. A SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER WAS CHOSEN TO TREAT THE PATIENT. THE PATIENT HAD A TIGHT CHRONIC TOTAL OCCLUSION OF THIS AREA. IN THE PROCESS OF THE PHYSICIAN ADVANCING THE TURBO ELITE DEVICE THROUGH THIS AREA FOR THE LAST PASS AFTER COMPLETING MULTIPLE PASSES THROUGH THE LESION, THE CATHETER REPORTEDLY WAS COMPROMISED. THERE WAS LIGHT OBSERVED FLASHING OUT OF THE DEVICE'S SHEATH AND THERE WAS OBSERVABLE FRACTURE IN THE SAME PORTION FROM WHICH THE LIGHT EMITTED. THIS AREA OF THE TURBO ELITE DEVICE WAS OUTSIDE THE PATIENT'S BODY. THERE WAS NO REPORTED PATIENT OR USER HARM. THE TURBO ELITE DEVICE WAS REMOVED SAFELY FROM THE PATIENT. THE CASE WAS THEN SUCCESSFULLY COMPLETED USING A BALLOON AND STENT. 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: Unintended Radiation Exposure

  MAUDE report 12062173 ↗
• MalfunctionMay 18, 2021Break; Break

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED ON 10 FEB 2021 TO TREAT AN OCCLUDED DISTAL SEGMENT OF THE PATIENT''S SUPERFICIAL FEMORAL ARTERY (SFA). THE PHYSICIAN CHOSE TO USE A SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER TO TREAT THE PATIENT. DURING USE IN THE PROCEDURE, IT WAS REPORTED THAT THE DEVICE WAS FRAYED WITH WIRES STICKING OUT. A NEW DEVICE WAS OPENED AND THE PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT HARM. IN SUBSEQUENT CONVERSATIONS WITH THE PHILIPS REPRESENTATIVE WHO WAS PRESENT IN THE PROCEDURE, HE REPORTED THAT NO WIRES WERE STICKING OUT OF THE DEVICE, THE SHAFT OF THE CATHETER APPEARED WHITE IN COLOR, AND APPROXIMATELY MID WAY UP THE WORKING LENGTH OF THE DEVICE, RED LIGHT WAS SEEN THROUGH THE OUTER JACKET. THERE WERE NO HOLES OR BREACHES SEEN IN THE DEVICE, SO THE COMPLAINT WAS DEEMED NOT REPORTABLE AT THAT TIME. HOWEVER, UPON RETURN OF THE DEVICE TO THE MANUFACTURER FOR EVALUATION, IT HAS BECOME A REPORTABLE EVENT. 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 EVALUATION IS CAPTURED.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 11845791 ↗
• MalfunctionOct 16, 2020Mechanical Jam; Mechanical Jam

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED, INDICATION FOR PROCEDURE UNAVAILABLE BUT INFORMATION WAS REQUESTED. THE PHYSICIAN CHOSE TO USE A SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER TO TREAT THE PATIENT. INITIALLY, THE COMPLAINT WAS THAT THE DEVICE WOULD NOT ADVANCE OVER A VIPER WIRE. A SECOND TURBO ELITE DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH NO REPORTED PATIENT HARM. HOWEVER, WHEN THE TURBO ELITE CATHETER WAS RETURNED TO THE MANUFACTURER, AND EVALUATED ON 01 OCT 2020, IT WAS DISCOVERED THAT THERE WAS A BREACH IN THE DEVICE'S OUTER 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: Radiation Exposure, Unintended

  MAUDE report 10692722 ↗
• MalfunctionOct 16, 2020Material Separation; Material Separation

  A PERIPHERAL ATHERECTOMY PROCEDURE COMMENCED, USING A SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER. PATIENT INFORMATION AND CASE DETAIL WERE REQUESTED, BUT MINIMAL INFORMATION WAS PROVIDED (THE PHILIPS REPRESENTATIVE WAS NOT PRESENT AT THE PROCEDURE, AND THE INFORMATION WAS OBTAINED VIA THE FACILITY/PHYSICIAN TO THE REP). IT WAS REPORTED THAT THE DEVICE TIP BROKE OFF, BUT NOT INSIDE THE PATIENT; INSTEAD IT REPORTEDLY BROKE OFF UPON REMOVAL OF THE DEVICE. THERE WAS NO REPORTED EMBOLISM. THE CASE WAS REPORTEDLY COMPLETED WITH OTHER PRODUCTS, WITH NO REPORTED HARM TO THE PATIENT. ADDITIONAL INFORMATION OBTAINED DURING THE MANUFACTURER'S DEVICE EVALUATION OCCURRING 15 OCT 2020 CONFIRMED THERE WAS NO DEVICE TIP BREAK AND NO PORTION OF THE DEVICE HAD DETACHED; INSTEAD, A BREACH IN THE DEVICE'S OUTER JACKET WAS DISCOVERED. ADDITIONAL DEVICE EVALUATION INFORMATION IS PRESENT. THIS REPORT IS BEING SUBMITTED DUE TO THE POTENTIAL FOR EXPOSURE TO MANUFACTURING MATERIALS AS WELL AS INADVERTENT EXPOSURE TO LASER ENERGY/RADIATION.

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 10692216 ↗
• MalfunctionJul 22, 2020Break; Break

  A PERIPHERAL VASCULAR INTERVENTION PROCEDURE COMMENCED TO TREAT A CHRONIC TOTAL OCCLUSION (CTO) OF A MODERATELY CALCIFIED POPLITEAL LESION, USING A CONTRALATERAL APPROACH (ACCESS TO THE LESION WAS GAINED FROM THE OPPOSITE LEG). A SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER WAS UTILIZED TO TREAT THE LESION. PER REPORT, THE PHYSICIAN WAS HOLDING THE DEVICE'S WORKING LENGTH IN ORDER TO ADVANCE THE DEVICE, AND IT WAS BECOMING DIFFICULT TO PUSH. DURING THE PROCEDURE, THE TEAM NOTICED A BREAK IN THE LASER CATHETER IN THE AREA CLOSE TO WHERE THE PHYSICIAN WAS HOLDING THE CATHETER, AND THE TEAM SAW RED LIGHT GLOWING FROM THE AREA. AT THAT POINT, THE TURBO ELITE WAS REMOVED FROM THE BODY. THE PHYSICIAN THEN USED A BALLOON TO FINISH THE PROCEDURE. THE PATIENT SURVIVED THE PROCEDURE WITH NO REPORTED PATIENT INJURY. 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: Radiation Exposure, Unintended

  MAUDE report 10311625 ↗
• InjuryJul 10, 2020Material Separation; Material Separation

  A PERIPHERAL VASCULAR INTERVENTION PROCEDURE COMMENCED TO TREAT A SEVERELY CALCIFIED LESION IN THE PATIENT'S DISTAL POSTERIOR TIBIAL ARTERY USING AN IPSILATERAL APPROACH (ACCESS TO THE LESION WAS PERFORMED ON THE SAME SIDE OF THE BODY AS THE LOCATION OF THE LESION). USING A SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER, THE PHYSICIAN WAS ABLE TO ACCESS THE LESION. UPON THE SECOND INSERTION OF THE DEVICE TO TREAT THE LESION, WHEN THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY, IT WAS REPORTED THAT THE TIP OF THE LASER BROKE OFF. THE TIP REMAINED IN THE PATIENT'S BODY AND WAS NOT REMOVED AT THE TIME OF THE PROCEDURE (DETAILS UNKNOWN). IT WAS REPORTED THAT THERE WAS RESISTANCE UPON ADVANCEMENT OF THE DEVICE WITHIN THE VASCULATURE AND THAT THERE WAS NO OTHER DEVICE USED SIMULTANEOUSLY DURING THE USE OF THE TURBO ELITE DEVICE. IT WAS BELIEVED, PER REPORT, THAT THE PATIENT WAS GOING TO SEE A VASCULAR SURGEON FOR ADDITIONAL TREATMENT SINCE THEY WERE UNSUCCESSFUL AT TREATING THE LESION DURING THIS PROCEDURE. THE PATIENT SURVIVED THE PROCEDURE. THIS EVENT IS ALSO BEING REPORTED DUE TO THE POTENTIAL FOR EXPOSURE TO MANUFACTURING MATERIALS AS WELL AS INADVERTENT EXPOSURE TO LASER ENERG

  Patient problems: Device Embedded In Tissue or Plaque; Iatrogenic Source; Radiation Exposure, Unintended

  MAUDE report 10261467 ↗
• MalfunctionNov 1, 2019Crack; Fracture; Deformation Due to Compressive Stress; Crack; Fracture; Deformation Due to Compressive Stress

  A PERIPHERAL VASCULAR INTERVENTION PROCEDURE COMMENCED TO TREAT A CHRONIC TOTAL OCCLUSION (CTO) IN THE PATIENT'S RIGHT ANTERIOR TIBIAL (AT) ARTERY. DURING THE PROCEDURE, THE REP REPORTED THE SPECTRANETICS TURBO ELITE COULD NOT CROSS THE CALCIFIED LESION. WHEN THE DEVICE WAS REMOVED FROM THE PATIENT, IT WAS REPORTED THAT THE DEVICE'S WORKING LENGTH ''BUCKLED'' AND CRACKED THE DEVICE'S OUTER JACKET, NEAR WHERE THE PHYSICIAN WAS HOLDING ONTO THE DEVICE. A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO USER OR PATIENT HARM WAS REPORTED. 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: Iatrogenic Source; Radiation Exposure, Unintended

  MAUDE report 9267998 ↗
• InjuryOct 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHILIPS REPRESENTATIVE REPORTED THAT A PERIPHERAL ATHERECTOMY PROCEDURE WAS PERFORMED TO RESOLVE A DE NOVO CHRONIC TOTAL OCCLUSION IN THE PATIENT'S LEFT ANTERIOR TIBIAL ARTERY. THE PHYSICIAN USED A STEP BY STEP METHOD TO ADVANCE THROUGH THE VESSEL FROM A FEMORAL ACCESS POINT, UTILIZING A SPECTRANETICS TURBO-ELITE LASER ATHERECTOMY CATHETER 410-152 OVER A V14 CONTROLWIRE (BOSTON SCIENTIFIC) HYDROPHILIC GUIDE WIRE. UPON REACHING THE TIP OF THE GUIDE WIRE, PART OF THE WIRE COATING WAS SHAVED OFF WITHIN APPROXIMATELY 2 SECONDS OF LASING TO CROSS THE LESION. THE TIBIO PERONEAL TRUNK WAS TREATED PRIOR TO THIS VESSEL AND SUCCESSFULLY OPENED RESULTING IN GOOD OUTFLOW FOR THE PATIENT. THE PROCEDURE WAS STOPPED AT THIS POINT AND THE PATIENT WAS DISCHARGED PER NORMAL PROCEDURE. THERE WAS NO CHANGE IN OUTFLOW TO THE ANTERIOR TIBIAL ARTERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8016114 ↗
• MalfunctionAug 24, 2018Material Puncture/Hole; Material Puncture/Hole

  A PROCEDURE BEGAN TO TREAT A PATIENT USING A SPECTRANETICS TURBO ELITE DEVICE. DURING PREPARATION FOR USE, THE FACILITY REPORTED THAT THE TEAM SAW LIGHT COMING SIDEWAYS FROM NEAR THE DISTAL TIP OF THE DEVICE. THE DEVICE DID NOT ENTER THE PATIENT; ANOTHER DEVICE WAS OPENED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY 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.

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 7813457 ↗