HawkOne™ H1-LSRecalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00643169968486), received between Aug 23, 2018 and Sep 18, 2026 — classified as 6 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Difficult to Remove; Material Deformation

  It was reported that an H1-LS device was initially inserted into the patient without difficulty during treatment of calcified plaque lesions in the left superficial femoral and popliteal arteries at proximal, mid, and distal locations. Difficulty was reported when removing the device for cleaning. After cleaning, the device could not be loaded onto the Spider Filter wire because the wire would not enter the device nosecone. An issue involving the tip was reported; the tip did not detach, and the guidewire lumen was not torn or ripped. A 7FR x 45 Terumo Destination sheath and 7.0 Spider Filter embolic protection were used. The target vessel was post-dilated, with no pre-dilation performed. The device was safely removed from the patient, and the procedure was completed successfully using a new H1-LS device without difficulty. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50817342 ↗
• InjuryMay 29, 2026Entrapment of Device; Difficult to Remove

  IT WAS REPORTED THAT A PATIENT WITH A PREVIOUSLY IMPLANTED NON-MEDTRONIC COVERED STENT IN THE PROXIMAL-TO-MID RIGHT SUPERFICIAL FEMORAL ARTERY UNDERWENT AN ENDOVASCULAR PROCEDURE USING THE HAWKONE LS DIRECTIONAL ATHERECTOMY SYSTEM TO TREAT SIGNIFICANT IN-STENT RESTENOSIS NEAR THE OSTIUM OF THE STENT CLOSE TO THE PROFUNDA ORIGIN. THE LESION EXHIBITED APPROXIMATELY 90% STENOSIS WITH A 30MM LESION LENGTH AND MODERATE CALCIFICATION. DURING PROCEDURAL PLANNING, THE MEDTRONIC REP STATED THAT THE HAWKONE DEVICE IS NOT INDICATED FOR TREATMENT OF IN-STENT RESTENOSIS AND DISCUSSED THE RISK OF INTERACTION BETWEEN THE DEVICE BLADES AND STENT STRUTS. PHYSICIAN STATED HE HAD PREVIOUSLY USED DIRECTIONAL ATHERECTOMY IN IN-STENT RESTENOSIS (ISR) CASES AND WISHED TO PROCEED DUE TO THE SEVERITY OF THE LESION AND DESIRE FOR ADDITIONAL LUMINAL GAIN AND DEBULKING. THE MEDTRONIC REP ALSO STATED THAT THERE WAS NO EXPECTATION OR PRESSURE TO USE MEDTRONIC PRODUCTS DURING THE PROCEDURE. THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA. LEFT FEMORAL ACCESS WAS OBTAINED AND ANGIOGRAPHIC IMAGING WAS PERFORMED. A 7X45 NON-MEDTRONIC SHEATH WAS USED, FOLLOWED BY A 035X150 TRAILBLAZER SUPPORT CATHETER, AND A 5MM SPI

  Patient problems: Perforation; Vascular Dissection

  MAUDE report 25329737 ↗
• MalfunctionDec 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING TREATMENT OF A CALCIFIED LESION IN THE MID RIGHT SUPERFICIAL FEMORAL ARTERY USING THE HAWKONE DEVICE, THE CATHETER DETACHED FROM THE STRAIN RELIEF WHILE THE PHYSICIAN WAS RETRACTING THE DEVICE TO REPOSITION IT AND NOTICED THE DEVICE WOULD NOT TORQUE, RESULTING IN A DELAY IN SURGERY OF FIVE MINUTES. THE LESION WAS CHARACTERIZED BY 80% STENOSIS, 40MM LENGTH, 7MM ARTERY DIAMETER, MODERATE CALCIFICATION, AND MINIMAL TORTUOSITY. THE PROCEDURE INVOLVED USE OF A 7FR NON-MEDTRONIC (TERUMO DESTINATION) SHEATH, 6MM SPIDERFX GUIDEWIRE AND EMBOLIC PROTECTION DEVICE, AND POST-DILATION WITH A 6MM IN.PACT 018 DEVICE. NO RESISTANCE WAS ENCOUNTERED DURING DEVICE ADVANCEMENT, AND NO DAMAGE WAS NOTED TO THE PACKAGING OR DURING DEVICE PREPARATION. THE INSTRUCTIONS FOR USE WERE FOLLOWED WITHOUT ISSUE. THE DETACHED PORTION OF THE CATHETER WAS OUTSIDE OF THE BODY AND WAS REMOVED, AND THE PROCEDURE WAS COMPLETED USING A NEW H1-LX DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23877685 ↗
• MalfunctionNov 11, 2024Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  A PHYSICIAN WAS USING A HAWKONE ATHERECTOMY DEVICE FOR TREATMENT OF A 100MM CALCIFIED LESION WITH CHRONIC TOTAL OCCLUSION IN THE PROXIMAL REGION OF THE RIGHT SUPERFICIAL FEMORAL ARTERY. THE ARTERY WAS 6MM IN DIAMETER WITH MODERATE CALCIFICATION AND TORTUOSITY.. A 7FR NON MEDTRONIC SHEATH WAS USED WITH A 0.014" NON MEDTRONIC GUIDEWIRE. THE IFU WAS FOLLOWED. THE VESSEL WAS NOT PRE-DILATED. IT WAS REPORTED SEVERE RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT OF THE DEVICE, EXCESSIVE FORCE WAS NOT USED. REMOVAL DIFFICULTIES WERE ALSO MET, THE PHYSICIAN PULLED WITH RESISTANCE REMOVING THE DEVICE SUCCESSFULLY IN TANDEM WITHOUT INJURY OR INTERVENTION. THE VESSEL WAS POST DILATED WITH AN EVERCOSS AND AN IMPACT ADMIRAL WAS USED FOR ANGIOPLASTY. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20650870 ↗
• MalfunctionAug 12, 2024Material Deformation; Material Deformation

  PHYSICIAN ATTEMPTED TO USE A HAWKONE LS ATHERECTOMY DEVICE DURING PROCEDURE TO TREAT A CALCIFIED FIBROUS LESION IN THE PATIENTS SUPE RFICIAL FEMORAL ARTERY (SFA). THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE WITHOUT ISSUE. EMBOLIC PROTECTION WAS USED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. SUCCESSFUL PASSES WERE MADE WITH THE DEVICE. RESISTANCE WAS ENCOUNTERED WHEN ATTEMPTING TO REMOVE THE DEVICE THROUGH THE SHEATH. DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT AND NO HARM WAS ENCOUNTERED WITH THE PATIENT. IT WAS REPORTED THE CENTER OF THE NOSECONE OF THE DEVICE WAS OBSERVED TO THE KINKED/ENLARGED POSSIBLY DUE TO OVERFILLING OF PLAQUE. THE SCRUB TECHNICIAN INDICATED THEY PICKED OUT THE PLAQUE FROM THE CENTER OF THE NOSECONE WITH THE TWEEZERS THAT ARE PROVIDED IN THE PACKAGE. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. THERE IS A SMALL PUNCTURE IN THE NOSECONE, HOWEVER, THE PUNCTURE WAS CREATED AFTER THE CATHETER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19959166 ↗
• MalfunctionJun 26, 2024Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  PHYSICIAN ATTEMPTED TO USE A HAWKONE LS ATHERECTOMY DEVICE WITH A 7FR NON-MEDTRONIC SHEATH AND A SPIDER FX EMBOLIC PROTECTION DEVICE/GUIDEWIRE DURING PROCEDURE TO TREAT A 250MM PLAQUE LESION IN THE PATIENTS RIGHT MID SUPERFICIAL FEMORAL ARTERY (SFA). SEVERE VESSEL TORTUOSITY WAS REPORTED. LESION EXHIBITED 40% STENOSIS. ARTERY DIAMETER REPORTED AS 5MM. THERE WERE ABNORMALITIES REPORTED IN RELATION TO ANATOMY. TORTUOUS AORTIC BIFURCATION WAS REPORTED. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE WITHOUT ISSUE. THE VESSEL WAS NOT PRE-DILATED. THE VESSEL WAS POST-DILATED WITH A 6X200MM EVERCROSS BALLOON. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. REMOVAL DIFFICULTIES WERE REPORTED. PHYSICIAN USED THE HAWKONE DEVICE IN NORMAL FASHION, BUT WHEN IT WAS BEING REMOVED THE WIRE DETACHED FROM THE MONORAIL SYSTEM. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT WITHOUT INTERVENTION. NO VESSEL DAMAGE REPORTED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19612663 ↗
• MalfunctionJun 18, 2024Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  PHYSICIAN ATTEMPTED TO USE A HAWKONE M ATHERECTOMY DEVICE WITH A 55CM 7FR NON-MEDTRONIC SHEATH AND A WHOLEY GUIDEWIRE DURING PROCEDURE TO TREAT A 140MM CALCIFIED LESION IN THE PATIENTS RIGHT PROXIMAL MID SUPERFICIAL FEMORAL ARTERY (SFA). MODERATE VESSEL CALCIFICATION WAS REPORTED. ARTERY DIAMETER REPORTED AS 7MM. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE WITHOUT ISSUE. A 6MM SPIDER FX EMBOLIC PROTECTION DEVICE WAS USED. THE VESSEL WAS NOT PRE-DILATED. THE VESSEL WAS POST-DILATED WITH A 7X60NON-MEDTRONIC FOLLOWED BY A 7X80 <(>&<)> 7X60 INPACT 018 DCB BALLOONS. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. REMOVAL DIFFICULTIES WERE REPORTED. DEVICE WAS PREPPED AND LOADED ON TO SPIDER WIRE PER IFU. THE DEVICE WAS PULLED WITH RESISTANCE AND REMOVED SUCCESSFULLY IN TANDEM WITHOUT INJURY/INTERVENTION. THE DEVICE WAS SAFELY REMOVED FROM PATIENT, NO ISSUES OR DIFFICULTY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19556628 ↗
• MalfunctionFeb 22, 2024Material Deformation; Positioning Problem; Material Deformation; Positioning Problem

  PHYSICIAN ATTEMPTED TO USE A HAWKONE LS ATHERECTOMY DEVICE DURING TREATMENT OF A 60MM CALCIFIED LESION IN THE PATIENT¿S RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). SEVERE VESSEL TORTUOSITY AND SEVERE VESSEL CALCIFICATION WERE REPORTED. LESION EXHIBITED CTO (CHRONIC TOTAL OCCLUSION-100%) STENOSIS. ARTERY DIAMETER REPORTED AS 7MM. THERE WERE ABNORMALITIES REPORTED IN RELATION TO ANATOMY. STEEP ILIAC BI-FURCATION AND HEAVY CALCIUM WERE REPORTED. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THE DEVICE WOULD NOT CROSS CTO AFTER PRE-DILATING TO 3MM, MODERATE PRESSURE WAS APPLIED, MINIMAL ROTATION, THERE WAS NO WIRE WRAP. WOULD NOT REMOVE FROM THE BODY WITHOUT BRINGING THE WIRE BACK. THE DEVICE WAS SAFELY REMOVED WITH NO PATIENT HARM. ONCE REMOVED, UPON INSPECTION, THE GUIDEWIRE LUMEN WAS TORN FROM THE NOSECONE BUT THE GUIDEWIRE LUMEN HAD NOT FULLY DETACHED FROM DEVICE. NO PATIENT INJURY REPORTED. WHEN THE DEVICE WAS RETURNED TO THE MANUFACTURING FACILTY FOR EVALUATION, IT WAS NOTED THAT THE DEVICE WAS DAMAGED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18758728 ↗
• MalfunctionNov 6, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  PHYSICIAN ATTEMPTED TO USE A HAWKONE LS ATHERECTOMY DEVICE WITH A 6FR NON-MEDTRONIC (TERUMO) SHEATH AND A 4MM SPIDER FX EMBOLIC PROTECTION DEVICE/GUIDEWIRE DURING TREATMENT OF A 220MM CALCIFIED PLAQUE LESION IN THE PATIENT¿S RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) POPLITEAL ARTERY. ARTERY DIAMETER REPORTED AS 6MM. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. LITTLE VESSEL TORTUOSITY AND MODERATE VESSEL CALCIFICATION ARE REPORTED. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE. THE VESSEL WAS NOT PRE-DILATED. THE VESSEL WAS POST-DILATED. IT IS REPORTED PHYSICIAN WAS UNABLE TO CLOSE THE CUTTER WINDOW - THE ORANGE BUTTON WOULDN'T CLOSE THE CUTTER WINDOW AGAIN. THE POSITION OF THE CUTTER IN RELATION TO THE NOSECONE DURING DEVICE REMOVAL FROM THE PATIENT WAS HALF WAY INSIDE HOUSING, IT WOULDN¿T CLOSE ALL THE WAY. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. NO ANY DEFORMATION WAS NOTICED IN THE CUTTER. PHYSICIAN REMOVED HAWK DEVICE AND USED DCB TO COMPLETE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18072982 ↗
• MalfunctionJun 6, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A HAWKONE TO TREAT A PLAQUE LESION IN THE RIGHT MID SUPERFICIAL FEMORAL ARTERY. DEGREE OF TORTUOSITY WAS LITTLE. DEGREE OF CALCIFICATION WAS LITTLE. LESION STENOSIS WAS 70%. DEVICE WAS INSPECTED WITH NO ISSUES. DEVICE WAS PREPPED PER IFU. IT WAS REPORTED THAT THE DEVICE GOT A ¿BULGE IN THE MIDDLE AND RUPTURED AFTER NOT BEING FULL¿. THE DOCTOR WAS WORKING WITH A 7X45 DESTINATION SHEATH, AND A 300CM .014 NITREX WIRE. AFTER MAKING A FEW PASSES THE DEVICE WASN¿T PACKING PROPERLY, THE DOCTOR DOUBLE CHECKED AND COULD SEE ON XRAY THE MEC GOT A BULGE AND NEEDED TO BE REMOVED FROM THE PATIENT. THE DOCTOR WAS ABLE TO REMOVE THE DEVICE WITHOUT COMPLICATION. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17070329 ↗
• MalfunctionFeb 20, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN INTENDED TO USE A HAWKONE LS ATHERECTOMY DEVICE WITH A NON-MEDTRONIC (TERUMO) SHEATH DURING TREATMENT OF A 100MM CALCIFIED LESION THE PATIENT¿S PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). ARTERY DIAMETER IS REPORTED AS 50MM. SEVERE VESSEL TORTUOSITY AND SEVERE CALCIFICATION ARE REPORTED. LESION EXHIBITED 95% STENOSIS. SHEATH SIZE WAS 7 FRENCH TERUMO. GUIDEWIRE WAS A ZEBRA WIRE-.014 BY ABBOTT 315 CM IN LENGTH. THE IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. VERY MILD RESTRAINT WAS FELT DURING ADVANCEMENT- BIFURCATION WAS TORTUOUS. IT IS REPORTED THE TIP CAME LOOSE PULLING INTO SHEATH. GUIDEWIRE LUMEN WAS NOT RIPPED. THE TIP DID SEPARATE FROM HINGE PIN. THE LOOSE TIP WAS STILL ATTACHED SOMEWHAT. TIP CAME OUT WITH REST OF DEVICE ON REMOVAL. TORTUOUS ILIAC BIFURCATION PHYSICIAN BELIEVES SHEATH HAD SMALL KINK IN IT WHICH CAUSED HAWKONE TIP TO COME LOOSE. A NON-MEDTRONIC (BOSTON- JETSTREAM) DEVICE WAS USED AND ALSO HAD TIP COME LOOSE. SHEATH LOOKED KINKED WHEN PULLED AT END OF CASE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16404392 ↗
• MalfunctionAug 5, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  PHYSICIAN WAS ATTEMPTING TO USE A HAWKONE DIRECTIONAL ATHERECTOMY DURING PROCEDURE TO TREAT A MODERATELY CALCIFIED PLAQUE LESION IN THE RIGHT MID TO DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) WITH 55% - 90% STENOSIS. THE VESSEL WAS MODERATELY TORTUOUS. THE VESSEL DIAMETER WAS 7MM WITH DEFUSED LESION LENGTH. 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 OR WILL NOT CLOSE. ON THE THIRD PASS OF SECOND INSERTION INTO PATIENT AFTER STAFF HAD SUCCESSFULLY CLEANED AND FLUSHED THE DEVICE ONCE. THE PHYSICIAN WAS NOT ABLE TO SUCCESSFULLY CLOSE THE CUTTER. THE CUTTER STOPPED BUT IT WOULD NOT CLOSE. THE CUTTER WAS AT THE HOUSING DURING REMOVAL FROM PATIENT. THE DEVICE WAS SAFELY REMOVED FROM PATIENT. NO CUTTER DEFORMATION OR MISSING PIECE WAS OBSERVED. ANOTHER HAWKONE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15173267 ↗
• InjuryJun 21, 2022Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  PHYSICIAN WAS ATTEMPTING TO USE A HAWKONE DIRECTIONAL ATHERECTOMY DURING PROCEDURE TO TREAT A LITTLE CALCIFIED FIBROUS LESION IN THE MID SUPERFICIAL FEMORAL ARTERY (SFA) WITH CHRONIC TOTAL OCCLUSION (CTO-100%). THE VESSEL WAS MODERATELY CALCIFIED. THE DEVICE WAS I NSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT THE DEVICE GOT CAUGHT IN THE EXISTING STENT AND HAD TO HAVE A FEM-POP BYPASS TO FIX AND REMOVE THE DEVICE. PREVIOUSLY IMPLANTED STENT WAS NOT A MEDTRONIC STENT. THE TARGET VESSEL WAS TREATED PRIOR TO EVENT. THE PHYSICIAN WAS USING DEVICE IN A CONTRAINDICATED FASHION OF ATHERECTOMY OFF INSTENT RESTENOSIS. THERE WAS NO FURTHER PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 14754392 ↗
• MalfunctionApr 5, 2022Peeled/Delaminated; Material Deformation; Peeled/Delaminated; Material Deformation

  PHYSICIAN ATTEMPTED TO USE A HAWKONE ATHERECTOMY DEVICE AND SPIDER FX EMBOLIC PROTECTION DEVICE WITH A 7FR NON-MEDTRONIC SHEATH DURING TREATMENT OF A 250MM CALCIFIED LESION IN THE PATIENT'S MID LEFT SUPERFICIAL FEMORAL ARTERY AND POPLITEAL ARTERY. SLIGHT VESSEL TO RTUOSITY AND SEVERE CALCIFICATION ARE REPORTED. ARTERY DIAMETER REPORTED AS 6MM. LESION EXHIBITED 80% STENOSIS. IFU WAS FOLLOWED. THE VESSEL WAS NOT PRE-DILATED.  IT IS REPORTED THE SPIDER FX WOULD NOT PULL BACK INTO CATHETER WHEN PREPPING. A NEW SPIDER FX WAS OPENED AND USED. IT IS REPORTED DURING USE OF THE HAWKONE DEVICE THE MATERIAL FROM NOSECONE ¿LINE¿ CAME OFF. IT WAS THE LINE ON THE NOSE CONE USED TO SHOW THAT THE QUIDEWIRE LUMEN IS LINED UP. THE LINE WAS OBSERVED TO BE MISSING FROM THE OUTER MARKER FOR WIRE LUMEN THAT DID COME OUT OF THE PATIENT WITH THE DEVICE. PHYSICIAN WAS NOT AWARE OF THE DETACHMENT INSIDE THE PATIENT. RECOGNIZED THE DEFECT WHEN REMOVED FOR CLEANING. IMAGING DID NOT LEAD PHYSICIAN TO BELIEVE THERE WAS A FOREIGN BODY LEFT. ATHERECTOMY DEVICE WAS USED IN PATIENT. REPLACEMENT HAWKONE DEVICE WAS USED. NO PATIENT INJURY REPORTED. WHEN THE DEVICE WAS RETURNED FOR EVALUATION, IT WAS NOTED THAT THE LU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14010948 ↗
• MalfunctionMar 23, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  PHYSICIAN WAS ATTEMPTING TO USE THE HAWKONE DIRECTIONAL ATHERECTOMY DEVICE ALONG WITH A NON-MEDTRONIC 7FR SHEATH, A 0.014" SPIDER WIRE AND 5MM EMBOLIC PROTECTION DURING PROCEDURE TO TREAT SEVERELY CALCIFIED LESION IN THE RIGHT MID DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) WITH CHRONIC TOTAL OCCLUSION (CTO-100%). THE VESSEL WAS PRE AND POST DILATED. IFU WAS FOLLOWED. IT WAS REPORTED THAT AFTER CLEANING THE DEVICE IT APPEARED THAT THE CUTTER WOULD NOT CLOSE FULLY. WHEN THE DEVICE WAS USED TO COMPLETE MORE PASSES INSIDE THE BODY THE NOSECONE WOULD BECOME FULL AFTER ONLY ONE PASS. WHEN THE DEVICE WAS REMOVED FROM THE PATIENT AND SUBSEQUENTLY CLEANED, IT WAS NOTED THAT THE CUTTER WOULD NOT CLOSE ALL THE WAY. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO FURTHER ISSUES OBSERVED. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13861082 ↗
• MalfunctionMar 23, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  PHYSICIAN WAS ATTEMPTING TO USE THE HAWKONE DIRECTIONAL ATHERECTOMY DEVICE DURING PROCEDURE TO TREAT A LITTLE CALCIFIED PLAQUE LESION IN THE DISTAL TO MID LEFT SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY (POP) WITH CHRONIC TOTAL OCCLUSION (CTO-100%). THE ARTERY DIAMETER AND LESION LENGTH WERE 5MM AND 200MM RESPECTIVELY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER THE IFU WITH NO ISSUES. IT WAS REPORTED THAT THE DEVICE JAMMED AND WOULD NOT CLOSE. THE THUMB SWITCH WOULD NOT CLOSE PROPERLY DURING THE PROCEDURE WHEN TRYING TO TURN THE THUMBSWITCH TO THE OFF POSITION. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. THE THUMB SWITCH WAS ONLY PARTIALLY IN THE OFF POSITION, IT WAS NOT CLOSED FULLY WHEN BEING REMOVED FROM PATIENT. THERE WAS NO DEFORMATIONS NOTICED ON THE CUTTER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER HAWKONE- LS DEVICE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13860409 ↗
• InjuryJan 5, 2022Detachment of Device or Device Component; Device Damaged by Another Device; Detachment of Device or Device Component; Device Damaged by Another Device

  PHYSICIAN WAS ATTEMPTING TO USE A HAWKONE ATHERECTOMY DEVICE TO TREAT A LITTLE TORTUOUS, LITTLE CALCIFIED, PLAQUE LESION WITHIN THE MID SUPERFICIAL FEMORAL ARTERY. DEVICE PREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT DEVICE WAS CAUGHT ON A STENT STRUT AND WAS PINCHED. DEVICE WOULDN'T COME FREE SO THEY CALLED REP WHO TALKED THEM THROUGH GETTING THE DEVICE FREE FROM THE STENT. NOSECONE SEPARATED FROM CATHETER. NO INTERVENTION WAS REQUIRED FOR TIP REMOVAL. IT WAS TRAPPED BY THE SPIDER AND REMOVED WITH THE SHEATH. THE STENT WAS DAMAGED. PIECES OF THE STENT WERE INSIDE THE NOSE CONE. THE VESSEL HAD A SMALL DISSECTION. THE PROCEDURE WAS COMPLETED BY ACCESSING IPSILATERAL AND PLACING ANOTHER STENT. NO OTHER COMPLICATIONS WERE REPORTED. THERE WAS NO DAMAGE TO THE SPIDERFX DEVICE AND THE DAMAGED STENT WAS NOT A MEDTRONIC STENT. NO PATIENT INJURY REPORTED.

  Patient problems: Vascular Dissection

  MAUDE report 13167189 ↗
• MalfunctionSep 1, 2021Positioning Problem; Physical Resistance/Sticking; Positioning Problem; Physical Resistance/Sticking

  PHYSICIAN WAS ATTEMPTING TO USE HAWKONE DIRECTIONAL ATHERECTOMY DURING PROCEDURE TO TREAT A SEVERELY CALCIFIED LESION IN THE RIGHT DISTAL, MID AND PROXIMAL SUPERFICIAL FEMORAL ARTERY WITH CHRONIC TOTAL OCCLUSION (CTO-100%). THE VESSEL WAS LITTLE TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH ARE 6MM AND 240MM RESPECTIVELY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. THERE WAS RESISTANCE WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT THE HAWKONE WOULD NOT CROSS THE LESION. THE PHYSICIAN REMOVED THE DEVICE AND USED ANOTHER HAWKONE SUCCESSFULLY. THERE WAS AN ISSUE CLOSING THE CUTTER WINDOW. THE CUTTER WAS OUTSIDE THE HOUSING WHEN REMOVED FROM THE PATIENT. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. THERE WAS NO VESSEL DAMAGE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12411565 ↗
• MalfunctionJun 23, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  PHYSICIAN ATTEMPTED TO USE A HAWKONE ATHERECTOMY DEVICE DURING TREATMENT OF A 20CM PLAQUE LESION IN THE PATIENT¿S MID LEFT SUPERFICIAL FEMORAL ARTERY (SFA). ARTERY DIAMETER REPORTED AS 5MM. NO VESSEL TORTUOSITY OR CALCIFICATION WERE REPORTED. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER THE IFU WITH NO ISSUES IDENTIFIED. PER THE SCRUB USING THE DEVICE IN THE CASE, THE DEVICE WAS PREPPED IN NORMAL STANDARD FASHION WITH WHAT SEEMED TO BE PART OF THE FLUSH VALVE POPPING OUT OF PLACE, WHICH WAS IDENTIFIED PRIOR TO USE IN PATIENT. THE DEVICE WAS USED PROPERLY WITH THE SPIDER FX EMBOLIC PROTECTION DEVICE WITH A TOTAL OF THREE PASSES MADE BEFORE CLEANING. DURING THE CLEANING A PIECE OF ¿IN-ORGANIC¿ MATERIAL WAS RETRIEVED FROM THE NOSE CONE ITSELF. THE IN-ORGANIC MATERIAL IS NOT FROM PATIENT AND HAS NOT BE IDENTIFIED. IT DID NOT APPEAR TO BE THE PTFE LINER AS IT IS WHITE IN APPEARANCE. THE SPIDER WAS NOT DAMAGED DURING PROCEDURE. THE CASE WAS COMPLETED WITH ANOTHER H1-M DEVICE WITHOUT INCIDENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12049133 ↗
• MalfunctionApr 26, 2021Device Damaged by Another Device; Material Deformation; Device Damaged by Another Device; Material Deformation

  PHYSICIAN ATTEMPTED TO USE A HAWKONE ATHERECTOMY DEVICE WITH A 7FR SHEATH AND 0.014 NON-MEDTRONIC 0.014 GUIDEWIRE DURING TREATMENT OF A 60MM PLAQUE LESION IN THE PATIENT¿S DISTAL RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). ARTERY DIAMETER REPORTED AS 6MM. LESION EXHIBITED 80% STENOSIS. MODERATE VESSEL CALCIFICATION AND SLIGHT TORTUOSITY ARE REPORTED. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. VESSEL PRE-DILATION WAS NOT PERFORMED. IT IS REPORTED THAT WHEN ADVANCING THE DEVICE IN THE PATIENT MODERATE RESISTANCE WAS FELT. THE PHYSICIAN REMOVED THE DEVICE AND A SMALL WIRE WAS NOTED STICKING OUT OF THE BACK OF THE NOSECONE. THE WIRE WAS PART OF DEVICE. NO COMPONENTS OF THE DEVICE DETACHED. DEVICE WAS SAFELY REMOVED FROM PATIENT. THERE WAS NO VESSEL DAMAGE NOTED. THE PROCEDURE WAS THEN COMPLETED USING A 1.7MM LASER DEVICE FOLLOWED BY POST-DILATION WITH AN IN. PACT ADMIRAL DRUG COATED BALLOON. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11722653 ↗
• MalfunctionFeb 23, 2021Difficult to Remove; Device Damaged by Another Device; Difficult to Remove; Device Damaged by Another Device

  PHYSICIAN WAS ATTEMPTING TO USE HAWKONE DIRECTIONAL ATHERECTOMY ALONG WITH WITH NON-MEDTRONIC 7FR SHEATH AND GUIDEWIRE DURING PROCEDURE TO TREAT A MODERATELY CALCIFIED LESION IN THE LEFT PROXIMAL TO MID SUPERFICIAL FEMORAL ARTERY (SFA) WITH CHRONIC TOTAL OCCLUSION (CTO-100%). THE VESSEL WAS LITTLE TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH ARE 5MM AND 150MM RESPECTIVELY. THE LESION WAS PRE AND POST DILATED. IFU WAS FOLLOWED. IT WAS REPORTED THAT THE DEVICE MALFUNCTIONED DURING USE AND THE WIRE WRAP OCCURRED WHEN REMOVING THE DEVICE FROM THE PATIENT. THE DEVICE WAS REMOVED WITHIN THE SHEATH WITH RESISTANCE FELT DURING REMOVAL. THERE WAS NO CUTTER ISSUES OR DETACHED COMPONENTS REPORTED. THE PROCEDURE WAS COMPLETED BY PULLING OUT DEVICE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11364089 ↗
• MalfunctionFeb 16, 2021Difficult to Remove; Physical Resistance/Sticking; Difficult to Remove; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PHYSICIAN WAS ATTEMPTING TO USE A HAWKONE DEVICE TO TREAT A DISTAL SUPERFICIAL FEMORAL ARTERY LESION IN A PATIENT. THE LESION WAS CALCIFIED, WITH MODERATE CALCIFICATION. WITH 75% STENOSIS. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. DEVICE WAS PREPPED AS PER IFU. A NON-MEDTRONIC SHEATH WAS USED (7F COOK ANL2 SHEATH.). IT WAS REPORTED THAT THE DEVICE JAMMED/WILL NOT CLOSE ¿ THE DEVICE WAS USED AND CLEANED ONCE TO TREAT THE PROXIMAL SFA OVER A 6MM SPIDER. THE CUTTER WAS STUCK IN THE OPEN/EXPOSED POSITION. AFTER TWO - THREE PASSES AND SOME DEVICE DIRECTING THE WHEN TURNING OFF THE DEVICE WITH THE THUMB SWITCH, THE TECH NOTICED A WIRE PROTRUDING OUT OF THE DRIVESHAFT IN FRONT OF THE THUMB SWITCH. THE DEVICE WAS ATTEMPTED TO REMOVE BUT WOULDN¿T COME OUT AND THERE WAS A HIGH DEGREE OF RESISTANCE. UNDER FLUORO IT WAS IDENTIFIED THAT THE SPIDER WIRE WAS WRAPPED AROUND THE DEVICE AND THE SHEATH. AFTER A FAIR AMOUNT OF TORQUEING AND RESISTANCE, THE STAFF DECIDED TO REMOVE THE SPIDER, HAWK, AND SHEATH IN RELATIONSHIP AND LOSE ACCESS AND STOP THE CASE. THE CUTTER WAS OPENED AS THE DEVICE WAS BEING REMOVED. THE THUMBSWITCH NO LONGER ACTIVATED THE BLADE. T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11331976 ↗
• MalfunctionFeb 8, 2021Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  PHYSICIAN INTENDED TO USE A HAWKONE ATHERECTOMY DEVICE WITH A 6MM EMBOLIC PROTECTION DEVICE, 7FR SHEATH, AND NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A 10MM PLAQUE LESION IN THE PATIENT¿S MID SUPERFICIAL FEMORAL ARTERY (SFA). SLIGHT VESSEL TORTUOSITY AND MODERATE CALCIFICATION ARE REPORTED. ARTERY DIAMETER REPORTED AS 6MM. LESION EXHIBITED 80% STENOSIS. IFU WAS FOLLOWED. VESSEL PRE-DILATION WAS PERFORMED. IT IS REPORTED THAT SEVERE RESISTANCE WAS FELT DURING WITHDRAWAL OF THE DEVICE RESULTING IN THE TIP SEPARATING IN THE SHEATH. THE SHEATH WAS REMOVED AND REPLACED, AND THE CASE WAS FINISHED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11292158 ↗
• MalfunctionFeb 3, 2020Material Deformation; Mechanical Jam; Material Deformation; Mechanical Jam

  PHYSICIAN WAS ATTEMPTING TO USE A HAWKONE DIRECTIONAL ATHERECTOMY ALONG WITH A NON MEDTRONIC 7FR SHEATH, SPIDER WIRE AND 6MM SPIDER EMBOLIC PROTECTION TO TREAT A SEVERELY CALCIFIED LESION IN THE LEFT MID SFA WITH 70% STENOSIS. THE VESSEL IS MODERATELY TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH ARE 5-7MM AND 80MM RESPECTIVELY. PROCEDURAL STROKE CINERADIOGRAPHY IS AVAILABLE. THE VESSEL WAS NOT PRE DILATED BUT POST DILATED. IFU WAS FOLLOWED DURING PREPARATION, PROCEDURE AND POST PROCEDURE. IT WAS REPORTED THAT THE PHYSICIAN DESIRED TO TREAT THE COMMON FEMORAL ARTERY WITH THE SFA CHRONICALLY OCCLUDED. SPIDER WAS PLACED INTO THE PROFUNDA. PHYSICIAN ADVANCED DEVICE INTO AREA TO BE TREATED AND MADE ABOUT 10-20 PASSES. THE NOSECONE WAS NOT FULL AND STILL HAD SOME TO CONTINUE ATHERECTOMY. AFTER 15-20 PASSES, DEVICE WAS REMOVED TO TAKE AN ANGIOGRAM TO SEE PROGRESS MADE. THE BLADE WAS INSIDE THE NOSECONE DURING REMOVAL. THE DEVICE WAS NOT CLEANED WHEN PULLED OUT OF THE SHEATH. PHYSICIAN DECIDED TO CONTINUE TREAT A FEW MORE AREAS AND THE HAWKONE WAS ADVANCED INTO THE SHEATH. ONCE PHYSICIAN STARTED REMOVING PLAQUE, NOTICED THAT THE BLADE WAS STILL IN THE NOSECONE ALTHOUGH THE THUMB SWITCH

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9660289 ↗
• MalfunctionJan 31, 2020Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  PHYSICIAN INTENDED TO USE A HAWKONE DEVICE DURING TREATMENT OF A CALCIFIED CTO (CHRONIC TOTAL OCCLUSION-100%) IN THE PATIENT¿S DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) OF DIAMETER 5-6MM. SLIGHT VESSEL TORTUOSITY AND SEVERE CALCIFICATION ARE REPORTED. PRE-DILATION WAS PERFORMED USING A NON-MEDTRONIC 3MM BALLOON FOLLOWED BY A 4MM BALLOON. SEVERAL PASSES WERE MADE WITH THE HAWKONE. IT IS REPORTED THE GUIDEWIRE LUMEN ON THE TOP OF THE NOSECONE BEGAN TO SEPARATE AND DEBRIS WAS NOTED TO HAVE ESCAPED. ONCE THE SEPARATION WAS NOTED, THE DEVICE WAS NOT USED IN THE PATIENT. THE PROCEDURE IS REPORTED TO HAVE GONE WELL, AND NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9652366 ↗