TurboHawk™ TH-LX-M (UDI 00643169968424)Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00643169968424), received between Nov 26, 2018 and Jan 9, 2025 — classified as 5 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (18 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN ATTEMPTED TO USE A TURBOHAWK ATK ATHERECTOMY DEVICE FOR PATIENT TREATMENT IN THE MID SUPERFICIAL FEMORAL ARTERY WITH PLAQUE, CALCIFICATION AND 70% STENOSIS. NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. A NON-MEDTRONIC SHEATH WAS USED. IFU WAS FOLLOWED. VESSEL WAS PREDILATED IT IS REPORTED THAT THE BLADE OF THE DEVICE COULD NOT ROTATE DURING THE OPERATION, AND AFTER BEING REMOVED OUTSIDE THE BODY, THE BLADE BROKE AND COULD NOT BE USED. THE DEVICE WAS REPLACED WITH A NEW TURBOHAWK DEVICE, AND THE OPERATION WAS COMPLETED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21111202 ↗
• MalfunctionMay 20, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  A PHYSICIAN WAS USING A TURBOHAWK ATHERECTOMY DEVICE FOR TREATMENT OF A 10MM CALCIFIED LESION WITH 50% STENOSIS IN THE MID SUPERFICIAL FEMORAL ARTERY.  THE ARTERY WAS 5MM IN DIAMETER WITH MILD TORTUOSITY AND MODERATE CALCIFICATION. AN 8FR SHEATH AND A 0.0014 NON MEDTRONIC GUIDEWIRE WAS USED. THE VESSEL WAS PRE-DILATED. THE IFU WAS FOLLOWED. IT WAS REPORTED DURING THE ARTERIAL PLAQUE REMOVAL OF THE LOWER EXTREMITIES, THE GUIDE WIRE WAS USED TO GUIDE IT THROUGH THE LESION AFTER FOLLOWING THE NORMAL PROCEDURES. DURING THE PROCESS OF REMOVING THE PLAQUE, IT WAS JAMMED AND IDLING. AFTER IT WAS WITHDRAWN FROM THE BODY, IT WAS REASSEMBLED AND REMOVED, BUT THE PLAQUE STILL COULD NOT BE EFFECTIVELY REMOVED. THEN IT WAS REPLACED WITH A NEW PRODUCT AND THE SURGERY WAS SUCCESSFULLY COMPLETED. NO PATIENT INJURY. WHEN THE DEVICE WAS RETURNED IT WAS NOTED THAT THE TIP OF THE DEVICE WAS DETACHED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19349860 ↗
• MalfunctionMar 4, 2024Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  PHYSICIAN WAS ATTEMPTING TO USE A TURBOHAWK ATK ATHERECTOMY DEVICE DURING A PROCEDURE TO TREAT A 200MM CALCIFIED LESION IN THE PATIENT¿S LEFT PROXIMAL MID DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). NO VESSEL TORTUOSITY AND MODERATE VESSEL CALCIFICATION WERE REPORTED. LESION EXHIBITED 50% STENOSIS. ARTERY DIAMETER REPORTED AS 5MM. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER THE IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THE GUIDEWIRE CAVITY FELL OFF. PHYSICIAN FOLLOWED STANDARD PROCEDURES TO OPEN THE ROTATIONAL CATHETER TO USE. DURING THE INTRAOPERATIVE CLEANING PLAQUE OF THE COLLECTION CHAMBER, IT WAS FOUND THAT THE GUIDEWIRE CAVITY FELL OFF. A BALLOON WAS REPLACED FOR DILATION, AND THE OPERATION WENT SMOOTHLY WITHOUT AFFECTING PATIENT SAFETY. NO PATIENT INJURY REPORTED. GUIDEWIRE LUMEN TORE/RIPPED. DAMAGED COMPONENT REMAINED ATTACHED, HOWEVER WHEN THE DEVICE WAS RETURNED THE LUMEN WAS FULLY DETACHED FROM THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18826514 ↗
• MalfunctionSep 8, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  A PHYSICIAN WAS ATTEMPTING TO USE A TURBOHAWK ATHERECTOMY DEVICE FOR THE TREATMENT OF A 12MM LESION WITH CHRONIC TOTAL OCCLUSION IN THE MID REGION OF THE SUPERFICIAL FEMORAL ARTERY. THE ARTERY WAS 5MM IN DIAMETER WITH MODERATE TORTUOSITY AND CALCIFICATION. THE DEVICE WAS INSPECTED AND PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED DURING THE ROTARY CUTTING PROCESS, THE BLADE COULD NOT BE PUSHED FORWARD, AND THE SURGERY COULD NOT BE PERFORMED. IT WAS NOT POSSIBLE TO TURN OFF THE THUMBSWITCH. THE POSITION OF THE CUTTER IN RELATION TO THE NOSECONE DURING DEVICE REMOVAL FROM THE PATIENT WAS UNCLEAR. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17710175 ↗
• MalfunctionOct 18, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  A PHYSICIAN WAS USING A TURBOHAWK ATHERECTOMY DEVICE FOR TREATMENT OF A PLAQUE LESION IN THE PROXIMAL/MID REGION OF THE SUPERFICIAL FEMORAL ARTERY AND POPLITEAL ARTERY. THERE WAS MILD TORTUOSITY AND MODERATE CALCIFICATION. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED DURING THE PROCEDURE, THE PHYSICIAN MADE A NUMBER OF PASSES WITH NO ISSUE AND NO EXCESSIVE FORCE USED. THE PHYSICIAN NOTED THE NOSECONE FELT FULL, AND IT APPEARED SO ON THE ANGIOGRAM. THE TECH WAS ABLE TO PUSH THE TRIGGER ALL THE WAY FORWARD BUT FELT A BIZARRE RELEASE. WHEN ATTEMPTING TO CLEAN THE DEVICE WHEN IT WAS NOTED THAT THE TIP HAD DETACHED FROM THE CATHETER AND WAS HANGING ON WIRE. NO PIECES OF THE DEVICE WAS LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED BY OPENING A NEW DEVICE. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15623546 ↗
• MalfunctionSep 5, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  PHYSICIAN WAS ATTEMPTING TO USE A TURBOHAWK DIRECTIONAL ATHERECTOMY DURING PROCEDURE TO TREAT A NON CALCIFIED SOFT TISSUE LESION WITH NONE TORTUOUS VESSEL. IT WAS REPORTED THAT THE DEVICE JAMMED/WILL NOT CLOSE. IT WAS POSSIBLE TO TURN OFF THE THUMBSWITCH. THE CUTTER DRIVER/THUMBSWITCH STOPPED FUNCTIONING WHILE IN USE IN THE PATIENT. THE POSITION OF THE CUTTER WHEN CRASHED IS UNKNOWN. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. NO DEFORMATION NOTICED IN THE CUTTER. NO PIECES OF THE CUTTER NOTICED TO BE MISSING. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15354908 ↗
• InjuryJun 16, 2022Peeled/Delaminated; Detachment of Device or Device Component; Material Deformation; Peeled/Delaminated; Detachment of Device or Device Component; Material Deformation

  PHYSICIAN USED A TURBOHAWK DIRECTIONAL ATHERECTOMY DURING PROCEDURE TO TREAT A LITTLE CALCIFIED PLAQUE LESION WITH CHRONIC TOTAL OCCLUSION (CTO-100%). THE VESSEL WAS A LITTLE TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH ARE 5MM AND 100MM RESPECTIVELY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT AFTER THE ROTARY EXCISION, THE EXCISED PLAQUES APPEARED MATERIAL SIMILAR TO NON-HUMAN TISSUE, TRANSLUCENT LIKE PLASTIC, AND THE BLOOD VESSEL WAS RUPTURED DURING THE EXCISION PROCESS. THE DEVICE WAS NOT DAMAGED. PATIENT COMPLICATIONS ASSOCIATED WITH THIS EVENT ARE VESSEL DAMAGE/INJURY AND PERFORATION. BALLOON COMPRESSION WAS USED TO TREAT VESSEL DAMAGE/PERFORATION. NO FURTHER PATIENT INJURY REPORTED. THE PATIENT HAS BEEN DISCHARGED.

  Patient problems: Perforation

  MAUDE report 14712358 ↗
• MalfunctionMay 31, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  PHYSICIAN USED A TURBOHAWK ATHERECTOMY DEVICE DURING PATIENT TREATMENT. THE VESSEL WAS PRE-DILATION WITH A 2MM BALLOON. MODERATE VESSEL TORTUOSITY IS REPORTED. IT WAS REPORTED THE CUTTER HEAD COULD NOT BE NORMALLY EXPOSED TO THE CUTTING WINDOW DURING THE OPERATION, SO IT WAS REPLACED WITH ANOTHER PRODUCT OF THE SAME MODEL TO CONTINUE TO COMPLETE THE OPERATION. ONE PASS WAS MADE WITH THE DEVICE PRIOR TO THE ISSUE BEING NOTED. THE DEVICE WAS NOT OVERFILLED. NO DAMAGE WAS NOTED TO THE DEVICE. IT WAS POSSIBLE TO TURN OFF THE THUMBSWITCH. THE CUTTER DRIVER/THUMBSWITCH DID NOT STOP FUNCTIONING WHILE IN USE IN PATIENT. THE CUTTER WAS OUTSIDE HOUSING IN RELATION TO THE NOSECONE DURING DEVICE REMOVAL FROM THE PATIENT. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. NO DEFORMATION WAS NOTICED IN THE CUTTER. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14546428 ↗
• InjuryApr 14, 2022Entrapment of Device; Difficult to Remove; Entrapment of Device; Difficult to Remove

  PHYSICIAN WAS ATTEMPTING TO USE THE HAWKONE ATHERECTOMY DEVICE DURING PROCEDURE TO TREAT MODERATELY CALCIFIED FIBROUS PLAQUE IN THE DISTAL RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) WITH CHRONIC TOTAL OCCLUSION (CTO -100%). THE VESSEL HAD MODERATELY TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH WAS 5MM AND 13MM RESPECTIVELY. THE DEVICE WAS INSPECTED AND PREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT DURING THE SURGERY, THE PHYSICIAN FIRST USED A 2MM BALLOON TO PRE-DILATE THE TARGET LESION VESSEL OF THE SFA, THEN THE DISTAL POPLITEAL ARTERY WAS PROTECTED WITH A 4MM SPIDER. THE HAWK CUTTER HEAD WAS FLUSHED ACCORDING TO STANDARD PROCEDURE,EXCHANGED AND THEN DELIVERED TO THE TARGET LESION VESSEL. FOLLOWING THE VASCULAR 3 O'CLOCK DIRECTION, ROTATION CUT FROM THE PROXIMAL OF THE BLOOD VESSEL TO THE DISTAL END. PUSHED THE PUSH ROD OF THE RECOVERY BIN TO THE FRONT. AT THIS TIME, THE PHYSICIAN WAS READY TO WITHDRAW THE BLADE TO CHECK THE ROTARY CUTTING SITUATION. IT WAS FOUND THAT DURING THE WITHDRAWAL PROCESS, THE DISTAL SPIDER RETREATED WITH THE ROTARY BLADE. AFTER REPEATED ATTEMPTS,  IT STILL COULD NOT BE SOLVED. FINALLY, THE BLADE WAS WITHDRAWN RELATIVELY VIGOROUSLY. AFTE

  Patient problems: Vascular Dissection

  MAUDE report 14111378 ↗
• MalfunctionMar 11, 2022Detachment of Device or Device Component; Difficult to Advance; Detachment of Device or Device Component; Difficult to Advance

  PHYSICIAN WAS ATTEMPTING TO USE TURBOHAWK DIRECTIONAL ATHERECTOMY ALONG WITH NON-MEDTRONIC 7FR SHEATH, GUIDEWIRE AND 7MM EMBOLIC PROTECTION DURING PROCEDURE TO TREAT A MODERATELY CALCIFIED LESION IN THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA) WITH CHRONIC TOTAL OCCLUSION (CTO-100%). THE VESSEL WAS NONE TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH ARE 6MM AND 100MM RESPECTIVELY. THEVESSEL WAS NOT PRE DILATED BUT POST DILATED. IFU WAS FOLLOWED. IT WAS REPORTED THAT MODERATE RESISTANCE OCCURRED DURING WITHDRAWAL AND THE TIP DETACHED BUT DID NOT SEPARATE AT THE HINGE PIN. THE NOSECONE DETACHED FROM CUTTER. THE DEVICE WOULD NOT COME OUT OF SHEATH AND WHEN FINALLY REMOVED, THE NOSE CONE WAS SEPARATED FROM CUTTER. THE DEVICE WAS SAFELY REMOVED FROM PATIENT. THE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13730769 ↗
• MalfunctionFeb 23, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  PHYSICIAN WAS ATTEMPTING TO USE THE TURBOHAWK ATHERECTOMY DEVICE DURING PROCEDURE TO TREAT MODERATELY CALCIFIED PLAQUE IN THE MID RIGHT SUPERFICIAL FEMORAL ARTERY (SFA).THE VESSEL HAD MODERATE TORTUOSITY AND EXHIBITED CTO (CHRONIC TOTAL OCCLUSION-100%). THE ARTERY DIAMETER WAS 6MM AND LESION LENGTH WAS 120MM. A NON-MEDTRONIC 7FR SHEATH AND 7MM SPIDER FX GUIDEWIRE/EMBOLIC PROTECTION DEVICE WERE USED. IFU WAS FOLLOWED. IT WAS REPORTED THAT THE DEVICE COULD NOT BE TURNED OFF WITH THUMB SWITCH AFTER MULTIPLE PASSES. THE CUTTER POSITION FOR REMOVAL OF THE DEVICE FROM THE PATIENT IS UNKNOWN. THE PROCEDURE WAS COMPLETED WITH A NEW TURBOHAWK DEVICE. THE VESSEL WAS POST DILATED. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13584230 ↗
• MalfunctionFeb 16, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN WAS ATTEMPTING TO USE THE TURBOHAWK ATHERECTOMY DEVICE DURING PROCEDURE TO TREAT LITTLE CALCIFIED PLAQUE IN THE PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). THE VESSEL HAD NO TORTUOSITY. THE DEVICE WAS INSPECTED AND PREPPED PER IFU WITH NO ISSUES NOTED. IT WAS REPORTED THAT THERE WAS TIP SEPARATION. THE TIP DID NOT COMPLETELY DETACH FROM THE DEVICE. THE DEVICE DETACHED AS IT WAS COMING OUT OF THE SHEATH. PRODUCT DID NOT COME APART IN PATIENTS BODY. DEVICE WAS IN PACK POSITION AND WAS COMING OUT OF THE PATIENT'S BODY/SHEATH. NO INTERVENTION WAS NOT REQUIRED. THE PROCEDURE WAS COMPLETED USING ANOTHER HAWK DEVICE TO FINISH THE ATHERECTOMY. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13540212 ↗
• MalfunctionNov 19, 2021Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  PHYSICIAN WAS ATTEMPTING TO USE THE TURBOHAWK ATHERECTOMY DEVICE DURING PROCEDURE TO TREAT MODERATELY CALCIFIED LESION IN THE DISTAL MID RIGHT SUPERFICIAL FEMORAL ARTERY(SFA) AND POPLITEAL ARTERY. THE VESSEL HAD MODERATE TORTUOSITY. THE DEVICE WAS INSPECTED AND PREPPED PER IFU WITH NO ISSUES NOTED. THE DEVICE WAS USED TO MAKE A SUCCESSFUL PASS THROUGH THE DISEASED PORTION OF THE VESSEL AND WAS REMOVED, CLEANED PROPERLY AND FULLY, AND REINSERTED. WHILE USING THE DEVICE TO CONTINUE TO CLEAR THE CALCIFICATION THE PHYSICIAN STARTED EXPERIENCING ISSUES GETTING THE PRODUCT TO PACK FOLLOWING A CUT JUST LIKE WAS EXPERIENCED PRIOR WITH ANOTHER TURBOHAWK DEVICE. IT GOT JAMMED A COUPLE OF TIMES BUT PHYSICIAN WAS ABLE TO GET IT TO PACK. PHYSICIAN CONTINUED USING THE DEVICE AS THE ISSUE SEEMED TO RESOLVE WHEN AN ODD FLEXION WAS NOTICED JUST DISTAL TO THE CUTTER WINDOW, SOMETHING THAT IS NOT NORMAL OR ASSOCIATED WITH THE JOG OF THE DEVICE. THE ODD FLEXION LOOKED LIKE IT WAS AT THE POINT WHERE THE HINGE THAT ATTACHES THE NOSECONE TO THE CATHETER PORTION, FLEXED PAST THE POINT THAT IT SHOULD BE, ALMOST AT A 45 DEGREE ANGLE. DURING THE REMOVAL, IT WAS MADE CLEAR THAT THE FLEXION SEEN WAS THE HINGE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12842507 ↗
• InjuryOct 28, 2021Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  PHYSICIAN WAS ATTEMPTING TO USE A TURBOHAWK ATHERECTOMY DEVICE TO TREAT A LESION. LESION STENOSIS WAS 99%. DEVICE WAS INSPECTED WITH NO ISSUES NOTED. A NON-MEDTRONIC GUIDEWIRE WAS USED. DEVICE PREPPED PER IFU, WITH NO ISSUES NOTED. IT WAS REPORTED THAT PATIENT HAD ACUTE BIFURCATION, PHYSICIAN HAD TROUBLE INITIALLY GETTING SHEATH UP AND OVER. ONCE SHEATH WAS IN PLACE THE LESION WAS IN THE MID SUPERFICIAL FEMORAL ARTERY (SFA), VERY TIGHT AND HIGHLY CALCIFIED LESION, THE PHYSICIAN DID PRE-DILATION WITH A 7MM NON-MEDTRONIC BALLOON, BEFORE INSERTING THE TURBOHAWK . PHYSICIAN MADE 4-5 PASSES. WHEN REMOVING THE TURBOHAWK FROM SHEATH PHYSICIAN MET RESISTANCE. WHEN THE TURBOHAWK WAS REMOVED IT WAS NOTED THAT THERE WAS A POSSIBLE WIRE PROLAPSE. NO INTERVENTION WAS REQUIRED FOR THE REMOVAL OF THE DEVICE. THE DEVICE WAS REMOVED FROM THE PATIENT; HOWEVER, IT WAS NOTED THERE WAS ILIAC DISSECTION IN THE PATIENT. THE PHYSICIAN STATED THAT THE DISSECTION HAPPENED WHEN THE DEVICE WAS PULLED BACK INTO THE SHEATH. 2 STENTS WERE PLACED IN THE RIGHT ILIAC TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: Vascular Dissection

  MAUDE report 12710258 ↗
• MalfunctionSep 16, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  PHYSICIAN INTENDED TO USE A TURBOHAWK ATHERECTOMY DEVICE DURING TREATMENT OF A 220MM CALCIFIED LESION IN THE PATIENT¿S MID PROXIMAL LEFT SUPERFICIAL FEMORAL ARTERY (SFA). SEVERE VESSEL CALCIFICATION AND LITTLE VESSEL TORTUOSITY ARE REPORTED. LESION EXHIBITED CTO (CHRONIC TOTAL OCCLUSION-100%) STENOSIS. ARTERY DIAMETER REPORTED AS 6MM. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. IT IS REPORTED THE DEVICE CUTTER JAMMED AND WOULD NOT CLOSE. IT WAS NOT POSSIBLE TO TURN OFF THE THUMBSWITCH. THE DEVICE WAS SUCCESSFULLY REMOVED. THE CUTTER WAS OUTSIDE THE HOUSING DURING REMOVAL FROM PATIENT. THE DEVICE WAS SAFELY REMOVED FROM PATIENT. NO DEFORMATION NOTED IN CUTTER. A HAWKONE LS DEVICE WAS USED TO COMPLETE THE PROCEDURE AND THE PATIENT WAS DISCHARGED HOME THE SAME DAY. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12479425 ↗
• MalfunctionAug 24, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  A PHYSICIAN WAS ATTEMPTING TO USE A TURBOHAWK ATHERECTOMY TO TREAT A SEVERELY CALCIFIED LITTLE TORTUOUS LESION IN THE LEFT MID SUPERFICIAL FEMORAL ARTERY (SFA) PRESENTING WITH 90% STENOSIS. ARTERY DIAMETER IS 6MM, AND LESION LENGTH 190MM. THE DEVICE WAS PREPPED WITH NO ISSUE. DEVICE PREPPED PER IFU. IT WAS REPORTED THAT THE DEVICE WAS JAMMED/WILL NOT CLOSE. THE TURBOHAWK DEVICE WOULD NOT CLOSE AFTER SEVERAL PASSES. THE DEVICE STOPPED FUNCTIONING WHILE IN USE IN THE PATIENT. THE CUTTER CRASHED OUTSIDE THE HOUSING. THE PHYSICIAN REMOVED THE DEVICE AND USED A DIFFERENT TURBOHAWK DEVICE SUCCESSFULLY. THE PHYSICIAN WAS ABLE TO TURN OFF THE THUMBSWITCH. DURING REMOVAL OF THE DEVICE FROM THE PATIENT THE CUTTER WAS LOCATED OUTSIDE THE HOUSING. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT WITH NO DEFORMATION NOTED IN THE CUTTER. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12358139 ↗
• MalfunctionApr 8, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  PHYSICIAN WAS ATTEMPTING TO USE A TURBOHAWK DIRECTIONAL ATHERECTOMY DURING PROCEDURE TO TREAT A PLAQUE LESION IN THE MID SUPERFICIAL FEMORAL ARTERY (SFA). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT THE DEVICE JAMMED AND WILL NOT CLOSE. THE CUTTER DRIVER WAS INSIDE THE HOUSING UNIT WHEN CRASH OCCURRED. IT WAS POSSIBLE TO TURN OFF THE THUMBSWITCH. THE CUTTER DRIVER/THUMBSWITCH DID NOT STOP FUNCTIONING WHILE IN USE IN PATIENT. CUTTER DRIVER WAS EXPOSED RELATIVE TO THE NOSECONE WHEN REMOVED FROM PATIENT. DEVICE WAS SAFELY REMOVED FROM PATIENT. NO DEFORMATION NOTICED IN CUTTER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11634895 ↗
• InjuryApr 6, 2021Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking; Detachment of Device or Device Component; Material Deformation; Physical Resistance/Sticking

  PHYSICIAN ATTEMPTED TO USE A TURBOHAWK ATHERECTOMY DEVICE DURING TREATMENT OF A CALCIFIED LESION IN THE PATIENT¿S DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). SLIGHT VESSEL CALCIFICATION AND TORTUOSITY ARE REPORTED. LESION EXHIBITED 80% STENOSIS. IFU WAS FOLLOWED. VESSEL PRE-DILATION WAS PERFORMED. RESISTANCE WAS NOTED DURING ADVANCEMENT. IT IS REPORTED DURING THE PROCEDURE THE CUTTER WAS DAMAGED. COLLECTION TUBE DETACHED AND REQUIRED RETRIEVAL FROM THE PATIENT USING A SNARE. A REPLACEMENT TURBOHAWK DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE VESSEL WAS POST-DILATED. NO FURTHER INJURY REPORTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11617704 ↗
• MalfunctionMar 29, 2021Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  PHYSICIAN USED A TURBOHAWK DEVICE WITH A NON-MEDTRONIC 7FR SHEATH AND 6MM SPIDER FX DURING TREATMENT OF A SOFT PLAQUE LESION IN THE MID SUPERFICIAL FEMORAL ARTERY (SFA). THE LESION WAS SOFT PLAQUE. IFU WAS FOLLOWED. IT IS REPORTED THAT TREATMENT WITH THE DEVICE WAS COMPLETE BUT DURING REMOVAL THE PACKING TUBE DETACHED FROM THE CATHETER INSIDE THE SHEATH. THE ENTIRE COLLECTION CHAMBER DID NOT DETACH FROM THE DEVICE. THE DETACHMENT OCCURRED WITHIN THE SHEATH. MODERATE RESISTANCE WAS NOTED DURING DEVICE REMOVAL. NO INTERVENTION WAS REQUIRED AND ALL DEVICE COMPONENTS WERE ACCOUNTED FOR. A SECOND TURBOHAWK WAS NOT NEEDED AS THE PROCEDURE WAS ALREADY COMPLETED. THERE WAS NO ISSUES NOTED WITH THE SPIDER FX. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11581768 ↗
• MalfunctionMar 19, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  PHYSICIAN WAS ATTEMPTING TO USE A TURBOHAWK ATHERECTOMY DURING PROCEDURE TO TREAT A SEVERELY CALCIFIED LESION IN THE MID RIGHT SUPERFICIAL FEMORAL ARTERY WITH CHRONIC TOTAL OCCLUSION (CTO-100%). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT THE DEVICE JAMMED AND WILL NOT CLOSE. THE CUTTER CRASHED AND WOULD NOT CLOSE WHILE IN USE IN VIVO. THE DEVICE WAS REMOVED WITH CUTTER NOT COMPLETELY CLOSED. THERE WAS NO RESIDUAL EFFECTS ON THE PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11525156 ↗
• MalfunctionMar 8, 2021Difficult to Remove; Detachment of Device or Device Component; Positioning Problem; Difficult to Remove; Detachment of Device or Device Component; Positioning Problem

  PHYSICIAN ATTEMPTED TO USE A TURBOHAWK ATHERECTOMY DEVICE WITH A 6FR SHEATH AND 0.014 NON-MEDTRONIC GUIDEWIRE DURING A PROCEDURE TO TREAT A 40MM LESION IN THE PATIENT¿S MID RIGHT POPLITEAL ARTERY. MODERATE VESSEL TORTUOSITY AND SEVERE CALCIFICATION ARE REPORTED. LESION EXHIBITED 90% STENOSIS. ARTERY DIAMETER REPORTED AS 5MM. IT IS REPORTED THAT THE POP WAS EXTREMELY CALCIFIED. VESSEL PRE-DILATION WAS PERFORMED. IT IS REPORTED THAT SEVERE RESISTANCE WAS NOTED DURING INITIAL ADVANCEMENT OF THE DEVICE AND IT WAS UNABLE TO CROSS THE LESION. DURING WITHDRAWAL, SEVERE RESISTANCE WAS FELT, AND IT IS REPORTED THAT TIP DAMAGE OCCURRED. IT IS REPORTED THAT THE NOSECONE FELL APART WHEN THE DOCTOR WAS FLUSHING THE DEVICE FOR THE SECOND TIME. THIS DID NOT OCCUR IN THE PATIENT. THE PHYSICIAN USED A NON-MEDTRONIC 3X40 TO CROSS THE LESION FOLLOWED BY A 5X40 NON-MEDTRONIC BALLOON TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11434864 ↗
• MalfunctionFeb 1, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  PHYSICIAN WAS ATTEMPTING TO USE A TURBOHAWK DIRECTIONAL ATHERECTOMY DURING PROCEDURE TO TREAT A MODERATELY CALCIFIED PLAQUE LESION IN THE LEFT DISTAL SUPERFICIAL FEMORAL ARTERY WITH 80% STENOSIS. THE VESSEL WAS LITTLE TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH ARE 6MM AND 125MM RESPECTIVELY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT THE DEVICE JAMMED/WILL NOT CLOSE. THE CUTTER DOOR JAMMED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11257118 ↗
• MalfunctionJan 25, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  PHYSICIAN INTENDED TO USE A TURBOHAWK ATHERECTOMY DEVICE DURING TREATMENT OF A PLAQUE LESION IN THE PATIENT¿S MID SUPERFICIAL FEMORAL ARTERY (SFA). IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. IT IS REPORTED THE DEVICE JAMMED AND WOULD NOT CLOSE. THE CUTTER WAS LOCATED OUTSIDE THE HOUSING DURING DEVICE REMOVAL FROM THE PATIENT. NO DEFORMATION WAS NOTED TO THE CUTTER. THE DEVICE WAS SAFELY REMOVED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11221836 ↗
• MalfunctionJan 13, 2021Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  PHYSICIAN WAS ATTEMPTING TO USE TURBOHAWK ATHERECTOMY WITH AN 8F NON-MEDTRONIC SHEATH DURING PROCEDURE TO TREAT A MODERATELY CALCIFIED PLAQUE FIBROUS LESION IN THE MID SUPERFICIAL FEMORAL ARTERY (SFA) WITH 80% STENOSIS. THE VESSEL IS LITTLE TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH ARE 5MM AND 15MM RESPECTIVELY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. THE GUIDEWIRE WAS HYDRATED AT PREP. THERE WAS NO RESISTANCE FELT DURING ADVANCEMENT OF DIRECTIONAL ATHERECTOMY DEVICE OVER THE GUIDEWIRE. THE DEVICE WAS NOT ADVANCED OVER A BIFURCATION. REMOVAL DIFFICULTY OCCURRED. IT WAS REPORTED THAT AFTER FIRST CUTTING AND PREPARING TO TAKE OUT OF THE BODY, IT WAS FOUND THAT THE GUIDE WIRE CAVITY WAS PEELED OFF FROM THE COLLECTION CAVITY, MAKING IT DIFFICULTY TO BE TAKEN OUT OF THE SHEATH. THE GUIDEWIRE WAS AT SFA AND THE DEEP FEMORIS WAS UNOBSTRUCTED. ANOTHER SHEATH WAS USED AND TIP AND SHEATH WERE PULLED OUT TOGETHER. IT WAS UNSHEATHED AFTER ARRANGED IN VITRO. NO VESSEL DAMAGES WAS NOTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11167209 ↗
• MalfunctionDec 8, 2020Material Deformation; Material Deformation

  PHYSICIAN INTENDED TO USE A TURBOHAWK DEVICE DURING TREATMENT OF A CALCIFIED AND PLAQUE LESION IN THE PATIENT¿S SUPERFICIAL FEMORAL ARTERY (SFA). MODERATE VESSEL TORTUOSITY AND SEVERE CALCIFICATION ARE REPORTED. LESION EXHIBITED 80% STENOSIS. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. PRE-DILATION WAS PERFORMED. RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE DEVICE. IT IS REPORTED DURING THE PROCEDURE TISSUE WAS UNABLE TO BE FLUSHED FROM THE DEVICE DURING CLEANING OUTSIDE THE PATIENT DUE TO DAMAGE TO THE CUTTER HEAD. THE CUTTER WAS OUTSIDE THE HOUSING THERE WERE NO DETACHED COMPONENTS OR CHIPS MISSING FROM THE CUTTER. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10964396 ↗