HawkOne™ H1-LXRecalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 00643169968509), received between Sep 25, 2018 and Apr 10, 2026 — classified as 4 injuries, 44 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 10, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING TREATMENT OF A CALCIFIED PERIPHERAL ARTERY LESION IN THE RIGHT MID SUPERFICIAL FEMORAL ARTERY USING THE HAWKONE DEVICE, THE THUMB SWITCH STOPPED WORKING AFTER TWO PASSES IN A HARD CALCIFIED LESION AND A MECHANICAL JAM WAS REPORTED. THE DEVICE WAS INITIALLY USED IN A SOFTER LESION IN THE COMMON FEMORAL ARTERY WITHOUT ISSUE. THE TARGET LESION WAS DESCRIBED AS MINIMALLY CALCIFIED WITH 60% STENOSIS, 40 MM LESION LENGTH, AND 6 MM VESSEL DIAMETER. EMBOLIC PROTECTION WAS USED WITH A SPIDERFX DEVICE, AND THE DEVICE WAS USED WITH A 7FR NON-MEDTRONIC SHEATH AND A 014 SPIDERFX WIRE. THE VESSEL WAS NOT PRE-DILATED AND WAS POST-DILATED USING A CHOCOLATE AND AN 018 DRUG COATED BALLOON. IT WAS REPORTED THAT IT WAS NOT POSSIBLE TO TURN OFF THE THUMB SWITCH, NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE, AND NO CUTTER DEFORMATION WAS NOTICED. DURING DEVICE REMOVAL, THE CUTTER POSITION WAS REPORTED AS OUTSIDE THE HOUSING, AND THE DEVICE WAS SAFELY REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW H1-LX DEVICE. NO HEALTH CONSEQUENCES OR IMPACT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24843806 ↗
• MalfunctionNov 11, 2024Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  PHYSICIAN ATTEMPTED TO USE A HAWKONE LX ATHERECTOMY DEVICE WITH A 7FR NON-MEDTRONIC (COOK ANSEL) SHEATH AND A 300MM NON-MEDTRONIC (FIELDER) GUIDEWIRE DURING PROCEDURE TO TREAT A 300MM CALCIFIED LESION IN THE PATIENTS RIGHT PROXIMAL MID SUPERFICIAL FEMORAL ARTERY (SFA). MINIMAL VESSEL TORTUOSITY AND SEVERE VESSEL CALCIFICATION WERE REPORTED. LESION EXHIBITED 75% STENOSIS. ARTERY DIAMETER REPORTED AS 5MM. 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. EMBOLIC PROTECTION WAS NOT USED. A 3.5-4.0 TAPERED NANOCROSS WAS USED FOR VESSEL PRE-DILATION. THE VESSEL WAS NOT POST-DILATED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. SEVERE RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS USED. REMOVAL DIFFICULTIES WERE REPORTED. THE DEVICE WAS PULLED WITH RESISTANCE AND REMOVED SUCCESSFULLY IN TANDEM WITHOUT INJURY/INTERVENTION. NO VESSEL DAMAGE REPORTED. THE DEVICE WAS SAFELY REMOVED FROM PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20650884 ↗
• MalfunctionOct 30, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  PHYSICIAN ATTEMPTED TO USE A HAWKONE LX ATHERECTOMY DEVICE WITH A 7FR NON-MEDTRONIC SHEATH AND A SPIDER FX EMBOLIC PROTECTION DEVICE/GUIDEWIRE DURING TREATMENT OF A 200MM FIBROUS PLAQUE LESION IN THE PATIENTS RIGHT MID DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). MINIMAL VESSEL CALCIFICATION WAS REPORTED. LESION EXHIBITED 80% STENOSIS. ARTERY DIAMETER REPORTED AS 6MM. 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. THE VESSEL WAS NOT PRE-DILATED. THE VESSEL WAS POST-DILATED WITH A NON-MEDTRONIC DEVICE. THE DEVICE WAS PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT THE HAWKONE LX DEVICE COMPLETED PASSES AND WAS SAFELY REMOVED FROM THE PATIENT TO CLEAN IT. UPON FLUSHING THE DEVICE TO REMOVE THE PLAQUE, A SMALL PIECE OF FOREIGN MATERIAL/BLACK PLASTIC EXITED THE FLUSH WINDOW. THE MATERIAL WAS SUSPECTED TO BE A PART OF THE DEVICE. THE MATERIAL WAS NOT PET LINER. T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20565746 ↗
• MalfunctionMay 16, 2024Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  PHYSICIAN ATTEMPTED TO USE A HAWKONE LX ATHERECTOMY DEVICE WITH A 7FR NON-MEDTRONIC (TERUMO DESTINATION) SHEATH AND A 5MM SPIDER FX EMBOLIC PROTECTION DEVICE/GUIDEWIRE DURING PROCEDURE TO TREAT A 300MM CALCIFIED LESION IN THE PATIENTS LEFT PROXIMAL MID DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). SEVERE VESSEL CALCIFICATION WAS REPORTED. LESION EXHIBITED MULTIPLE CTO¿S (CHRONIC TOTAL OCCLUSION-100%) STENOSIS. ARTERY DIAMETER REPORTED AS 5-6MM. 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. A 5MM .018 NON-MEDTRONIC (BOSTON SCIENTIFIC) PTA BALLOON WAS USED FOR PRE-DILATION. THE VESSEL WAS NOT POST-DILATED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED AFTER THE SECOND INSERTION AND 1ST PASS, THE DEVICE SEEMED TO DISCONNECT AND OPERATOR LOST A BIT OF CONTROL. TIP DAMAGE WAS REPORTED. THE GUIDEWIRE LUMEN WAS TORN/RIPPED. THE TIP DID NOT DETACH. THE PHYSICI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19330146 ↗
• InjurySep 5, 2023Material Deformation; Material Deformation

  PHYSICIAN ATTEMPTED TO USE A HAWKONE LX ATHERECTOMY DEVICE DURING TREATMENT OF A 100MM CALCIFIED LESION IN THE PATIENT¿S LEFT MID PO PLITEAL ARTERY. MODERATE VESSEL CALCIFICATION AND LITTLE VESSEL TORTUOSITY ARE REPORTED. LESION EXHIBITED CTO (CHRONIC TOTAL OCCLUSION-100%) STENOSIS. ARTERY DIAMETER REPORTED AS 5MM. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER THE IFU WITH NO ISSUES IDENTIFIED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. PHYSICIAN STATED THEY SAW A PERFORATION AFTER HAWKING. PHYSICIAN DID NOT SEE ISSUE WITH DEVICE UNTIL IT WAS REMOVED., THE PROXIMAL END OF THE GUIDEWIRE LUMEN WAS TORN BUT REMAINS ATTACHED. PATIENT REQUIRED PTA AS A RESULT OF THE PERFORATION.

  Patient problems: Perforation

  MAUDE report 17681464 ↗
• MalfunctionNov 14, 2022Device Damaged by Another Device; Material Deformation; Device Damaged by Another Device; Material Deformation

  PHYSICIAN WAS ATTEMPTING TO USE HAWKONE DIRECTIONAL ATHERECTOMY ALONG WITH A NON-MEDTRONIC 7FR SHEATH AND 7MM SPIDER GUIDEWIRE DURING PROCEDURE TO TREAT A SEVERELY CALCIFIED, PLAQUE LESION IN THE LEFT PROXIMAL, MID AND DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) WITH 90% STENOSIS. THE VESSEL WAS MODERATELY TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH ARE 6MM AND 400MM RESPECTIVELY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT THE WIRE PROLAPSED UPON REMOVAL OF DEVICE. THE PHYSICIAN WAS CAREFUL WHEN ROTATING THE DEVICE, OUR THOUGHTS WERE MAYBE THE SPIDER WIRE GOT CAUGHT ON SOME CALCIUM NEAR THE SHEATH AND LOOPED AROUND WHEN REMOVING. THE GUIDEWIRE LUMEN WAS TORN/RIPPED. THE DAMAGED COMPONENT REMAINED ATTACHED. THE PROLAPSE DID NOT RESULT IN INTERVENTION FOR REMOVAL OF DEVICES. PATIENT WAS NOT HARMED, EVERYTHING WAS REMOVED EXCEPT FOR A V18 WIRE TO KEEP ACCESS. AFTER REMOVAL ANOTHER 7F SHEATH WAS PLACED AND WE FINISHED THE CASE WITH DCB AND CHOCOLATE. THERE WAS NO PATIENT INJURY. WHEN THE DEVICE WAS RETURNED TO THE FACILITY FOR EVALUATION IT WAS NOTED THAT THE DEVICE WAS DAMAGED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15787610 ↗
• MalfunctionAug 5, 2022Peeled/Delaminated; Peeled/Delaminated

  PHYSICIAN WAS ATTEMPTING TO USE HAWKONE DIRECTIONAL ATHERECTOMY DURING PROCEDURE TO TREAT A MODERATELY CALCIFIED FIBROUS LESION IN THE MID SUPERFICIAL FEMORAL ARTERY (SFA). THE VESSEL WAS LITTLE TORTUOUS. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT PHYSICIAN WANTED TO TREAT DISEASED SFA WITH HAWK DEVICE. PHYSICIAN PRE DILATED THE SFA USING TWO DIFFERENT BALLOONS TO PREPARE FOR HAWK AND TO FIND THE SIGNIFICANT LESIONS WITHIN THE VESSEL. DEVICE WENT THROUGH SHEATH WITH NO RESISTANCE FELT AND DEVICE WORKED WITH NO ISSUES WHILE TREATING THE VESSEL. NOTICED THAT THE NOSECONE WAS GETTING FULL SO DEVICE WAS REMOVED TO CLEAN. WHEN REMOVED IT WAS NOTICED THAT A LONG CLEAR PLASTIC PIECE WAS WRAPPED ALONG THE OUTSIDE OF THE HAWK. PHYSICIAN STATED SHE CHECKED TO MAKE SURE THERE WAS NOT A STENT THAT WAS NOT VISUALIZED IN VESSEL AND ALSO CHECKED THE BALLOONS WHICH LOOKED TO BE INTACT. DEVICE OPEN AND CLOSED FINE AND IT DID NOT SEEM TO INTERFERE WITH OPERATION. THE PLASTIC WAS WRAPPED ON THE OUTSIDE OF THE DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15174495 ↗
• MalfunctionJul 21, 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 LEFT MID SUPERFICIAL FEMORAL ARTERY (SFA) WITH CHRONIC TOTAL OCCLUSION (CTO-100%). THE VESSEL WAS MODERATELY TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH ARE 5MM AND 150MM RESPECTIVELY. THE DEVICE WAS INSPECTED WITH NO ISSUES IDENTIFIED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT THE DEVICE WAS PUT INTO THE PATIENT. AFTER SEVERAL CUTS WERE MADE SUCCESSFULLY, THE THUMB SWITCH JAMMED AND WOULD NOT FULLY CLOSE. SEVERAL ATTEMPTS WERE MADE TO PUSH THE THUMB SWITCH INTO THE OFF POSITION, BUT THE THUMB SWITCH WOULD NOT FULLY MOVE INTO THE OFF POSITION. THEREFORE, THE DEVICE WAS REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW HAWKONE LS DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15072899 ↗
• MalfunctionMay 10, 2022Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  PHYSICIAN WAS ATTEMPTING TO USE A HAWKONE DIRECTIONAL ATHERECTOMY DURING PROCEDURE TO TREAT A LITTLE CALCIFIED PLAQUE LESION IN THE PROXIMAL, MID AND DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) WITH CHRONIC TOTAL OCCLUSION (CTO-100%). THE VESSEL WAS LITTLE TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH ARE 6MM AND 300MM RESPECTIVELY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. THE DEVICE WAS REPORTED JAMMED/WILL NOT CLOSE. IT WAS REPORTED THAT THE DEVICE WAS UNABLE TO BE REMOVED FROM THE SHEATH. ONCE EVERYTHING WAS INCLUDING THE SHEATH WAS REMOVED, A BULGE WAS OBSERVED IN THE AREA OF THE NOSECONE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14345276 ↗
• MalfunctionJan 5, 2022Peeled/Delaminated; Physical Resistance/Sticking; Peeled/Delaminated; Physical Resistance/Sticking

  PHYSICIAN USED A HAWKONE ATHERECTOMY DEVICE DURING TREATMENT OF A 40CM CALCIFIED AND PLAQUE CTO (CHRONIC TOTAL OCCLUSION-100%) IN THE PATIENT'S PROXIMAL, MID, AND DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). SLIGHT VESSEL TORTUOSITY AND MODERATE CALCIFICATION ARE REPORTED. ARTERY DIAMETER REPORTED AS 6MM. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED AS PER IFU. IT IS REPORTED DURING CLEANING OF THE DEVICE NOT EVERYTHING WOULD COME OUT. THE THUMB-SWITCH WOULD NOT GO ALL THE WAY FORWARD. IT WAS POSSIBLE TO TURN OFF THE THUMBSWITCH. CUTTER DID NOT CRASH. IT JUST FELT LIKE THE NOSECONE WAS FULL AND HAD TO BE CLEANED. DID NOT HAVE AS MUCH SLACK ON THE THUMBSWITCH. FURTHER INSPECTION REVEALED MORE DEBRIS IN NOSE CONE. THE CUTTER WINDOW AND CLEANING PORT WERE OPENED AND THE PHYSICIAN DISTALLY INSERTED BACK END OF MICRO WIRE IN CUTTER WINDOW TO DISLODGE VISIBLE DEBRIS WHICH LOOKED LIKE PLASTIC FROM SHEATH OR FLUSH TOOL. IN ADDITION TO THE REGULAR PLAQUE DEBRIS, THE PLASTIC STRIP WAS ALSO IN THE NOSECONE. THE PHYSICIAN COMMENTED THIS IS NOT THE FIRST TIME HE HAS EXPERIENCED THIS, IT HAS HAPPENED IN THE PAST. DEVICE WAS SAFELY REMOVED FROM PATIENT. POSITION OF CUTTER REL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13166980 ↗
• MalfunctionOct 22, 2021Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  PHYSICIAN USED A HAWKONE LX ATHERECTOMY DEVICE WITH A 7FR NON-MEDTRONIC SHEATH AND 0.014 X 300 NON-MEDTRONIC 0.035 X 260 AND 0.035 X 260 NON-MEDTRONIC GUIDEWIRE DEVICES DURING TREATMENT OF A 250MM PLAQUE LESION IN THE PATIENT¿S MID RIGHT SUPERFICIAL FEMORAL ARTERY. MODERATE VESSEL CALCIFICATION AND LITTLE VESSEL TORTUOSITY ARE REPORTED. LESION EXHIBITED 70% STENOSIS. ARTERY DIAMETER REPORTED AS 5-6MM. 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 THE TIP SEPARATES WHEN YOU ADVANCE THE THUMBSWITCH FORWARD. PHYSICIAN REMOVED THE DEVICE DUE TO NOTICING THE THUMB SWITCH FELT DIFFERENT. THE CUTTER WAS OUTSIDE THE HOUSING UNIT DURING REMOVAL. DEVICE WAS SAFELY REMOVED FROM PATIENT. NO INTERVENTION REQUIRED FOR REMOVAL. ONCE DEVICE WAS REMOVED, PHYSICIAN WAS FINISHED WITH ATHERECTOMY, SO FOLLOWED UP WITH DCB. NO VESSEL DAMAGE NOTED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12679764 ↗
• MalfunctionSep 13, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  PHYSICIAN WAS ATTEMPTING TO USE A HAWKONE DIRECTIONAL ATHERECTOMY DURING PROCEDURE TO TREAT A SEVERELY CALCIFIED LESION IN THE LEFT MID SUPERFICIAL FEMORAL ARTERY (SFA) WITH CHRONIC TOTAL OCCLUSION (CTO-100%). THE VESSEL WAS LITTLE TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH ARE 6MM AND 400MM 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 HAD DIFFICULTY PACKING, UPON REMOVAL OF THE DEVICE, THE CUTTER WAS STICKING OUT OF THE NOSECONE. THE CUTTER SLICED THROUGH THE NOSECONE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12458938 ↗
• MalfunctionSep 2, 2021Material Deformation; Material Deformation

  PHYSICIAN ATTEMPTED TO USE A HAWKONE ATHERECTOMY DEVICE WITH A 7FR NON-MEDTRONIC (CORDIS BRITE TIP) SHEATH AND 5MM SPIDER FX EMBOLIC PROTECTION DEVICE DURING TREATMENT OF A PLAQUE CTO (CHRONIC TOTAL OCCLUSION-100%) IN THE PATIENT¿S MID SUPERFICIAL FEMORAL ARTERY (SFA). SLIGHT VESSEL TORTUOSITY AND CALCIFICATION ARE REPORTED. IFU WAS FOLLOWED. THE GUIDEWIRE WAS HYDRATED AT PREPARATION. THE DEVICE WAS ADVANCED OVER THE BIFURCATION. IT IS REPORTED SEVERE RESISTANCE WAS NOTED DURING WITHDRAWAL AND THE TIP OF THE DEVICE BECAME DAMAGED. THE GUIDEWIRE LUMEN WAS NOT TORN FROM THE DISTAL TIP AND THE GUIDEWIRE DID NOT LOCK UP ON THE CATHETER. EVERYTHING WAS REMOVED FROM THE PATIENT THROUGH THE ACCESS SITE. THE SHEATH WAS REMOVED FOLLOWED BY THE HAWK OVER THE SPIDER WIRE AND LASTLY THE SPIDER BASKET. THERE WAS NO ISSUES NOTED WITH THE SPIDER FX. NO COMPONENTS DETACHED FROM THE DEVICE. THE PROCEDURE WAS COMPLETED BY THE REMOVAL OF THE DEVICES FROM THE PATIENT. NO PATIENT INJURY REPORTED. WHEN THE DEVICE WAS RETUNED FOR EVALUATION, IT WAS NOTED THAT THE GUIDEWIRE LUMEN WAS DAMAGED AND DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12413235 ↗
• MalfunctionJun 28, 2021Difficult to Advance; Difficult to Advance

  PHYSICIAN WAS ATTEMPTING TO USE HAWKONE DIRECTIONAL ATHERECTOMY DURING PROCEDURE TO TREAT 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 WHEN PRODUCT WAS INSERTED INTO PATIENT, PHYSICIAN NOTICED IT WOULD NOT TRACK OVER THE WIRE VERY WELL. PHYSICIAN PULLED IT OUT OF THE PATIENT AND NOTICED WIRE LUMEN WAS FRAYED. PHYSICIAN USED ANOTHER DEVICE TO COMPLETE PROCEDURE. NO INJURY TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12073759 ↗
• MalfunctionJun 11, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  PHYSICIAN WAS ATTEMPTING TO USE HAWKONE DIRECTIONAL ATHERECTOMY DURING PROCEDURE TO TREAT A MODERATELY CALCIFIED FIBROUS LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) WITH 90% STENOSIS. THE VESSEL WAS MODERATELY TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH ARE 6MM AND 60MM 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 AFTER ONE PASS. THE DEVICE WAS SAFELY REMOVED FROM PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11981235 ↗
• MalfunctionApr 9, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PHYSICIAN WAS ATTEMPTING TO USE A HAWKONE ATHERECTOMY DEVICE TO TREAT A LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY OF A PATIENT WITH PLAQUE AND LITTLE CALCIFICATION WITH 100% STENOSIS. THE DEVICE WAS PREPPED AS PER IFU. A NON-MEDTRONIC SHEATH AND A 6MM SPIDER FX WAS USED DURING THE PROCEDURE. IT WAS REPORTED THAT THE DEVICE WAS USED IN A PATIENT WITH INSTANT RESTENOSIS. MULTIPLE PASSES WERE MADE AND DEVICE WITH CLEANED WITHOUT ISSUE. DURING LAST INSERTION THE DEVICE DID NOT WANT TO CLOSE PROPERLY. THE POSITION OF THE CUTTER UPON DEVICE REMOVAL FROM THE PATIENT IS UNKNOWN. SO IT WAS REMOVED AND STILL WOULD NOT CLOSE PROPERLY AFTER CLEANING, SO ANOTHER DEVICE WAS OPENED, AND THE CASE WAS FINISHED WITHOUT INCIDENT. NO PATIENT INJURY REPORTED FOR THIS EVENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11639968 ↗
• MalfunctionApr 7, 2021Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  PHYSICIAN INTENDED TO USE A HAWKONE ATHERECTOMY DEVICE WITH A 7FR NON-MEDTRONIC (TERUMO) SHEATH AND 0.014 (THRUWAY) GUIDEWIRE DURING TREATMENT OF A 250MM FIBROUS AND PLAQUE LESION IN THE PATIENT¿S MID AND DISTAL RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). SLIGHT VESSEL CALCIFICATION AND TORTUOSITY ARE REPORTED. LESION EXHIBITED 90% STENOSIS. ARTERY DIAMETER REPORTED AS 5MM. IFU WAS FOLLOWED. EMBOLIC PROTECTION WAS NOT USED THE VESSEL WAS NOT PRE-DILATED. THE GUIDEWIRE WAS HYDRATED DURING PREPARATION. THE DEVICE WAS ADVANCED OVER THE BIFURCATION. NO RESISTANCE WAS NOTED. IT IS REPORTED THAT THE GUIDEWIRE LOCKED UP ON THE CATHETER. THIS WAS NOTED AFTER USE WHEN TRYING TO REMOVE THE DEVICE. THE PHYSICIAN HAD TROUBLE PULLING IT BACK INTO THE SHEATH. IT IS REPORTED THE WIRE WAS STUCK IN THE DEVICE AND COULD NOT BE REMOVED WITHOUT LOSING WIRE ACCESS ACROSS THE LESION. THE DEVICE AND WIRE WERE SAFELY REMOVED IN TANDEM WITHOUT INTERVENTION. THE CUTTER WAS LOCATED INSIDE THE HOUSING DURING DEVICE REMOVAL FROM THE PATIENT. THE PROCEDURE WAS THEN COMPLETED BY USING A BALLOON IN THE VESSEL. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11626244 ↗
• MalfunctionMar 29, 2021Difficult to Remove; Device Damaged by Another Device; Material Deformation; Difficult to Remove; Device Damaged by Another Device; Material Deformation

  PHYSICIAN WAS ATTEMPTING TO USE HAWKONE DIRECTIONAL ATHERECTOMY ALONG WITH A NON-MEDTRONIC 7FR SHEATH, SPIDER GUIDEWIRE AND 7MM EMBOLIC PROTECTION DURING PROCEDURE TO TREAT A MODERATELY CALCIFIED PLAQUE FIBROUS LESION IN THE LEFT MID SUPERFICIAL FEMORAL ARTERY (SFA). THE VESSEL WAS MODERATELY TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH ARE 6MM AND 100MM RESPECTIVELY. THE VESSEL WAS NOT PRE OR POST DILATED. IFU WAS FOLLOWED. IT WAS REPORTED THAT PHYSICIAN WAS NOT SURE WHAT BROKE OR HOW IT BROKE, THE DEVICE GOT STUCK INSIDE THE NON-MEDTRONIC SHEATH. THE PROCEDURE WAS NEAR TO COMPLETION, THE PHYSICIAN JUST PULLED/REMOVED EVERYTHING OUT OF THE ACCESS SITE AT ONCE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11580639 ↗
• MalfunctionDec 2, 2020Device Contamination with Chemical or Other Material; Physical Resistance/Sticking; Device Contamination with Chemical or Other Material; Physical Resistance/Sticking

  PHYSICIAN INTENDED TO USE A HAWKONE ATHERECTOMY DEVICE WITH A NON-MEDTRONIC 7FR SHEATH AND NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A 150MM FIBROUS AND PLAQUE CTO (CHRONIC TOTAL OCCLUSION-100%) IN THE PATIENT¿S MID AND DISTAL RIGHT SUPERFICIAL FEMORAL ARTERY AND POPLITEAL ARTERY. SLIGHT VESSEL TORTUOSITY AND MODERATE CALCIFICATION ARE REPORTED. ARTERY DIAMETER REPORTED AS 5MM. IFU WAS FOLLOWED. VESSEL PRE-DILATION WAS NOT PERFORMED. ITS IS REPORTED AFTER MAKING 2 PASSES THE THUMBSWITCH WOULD NOT FULLY RETRACT INTO THE OFF POSITION AS THERE WAS PLAQUE THAT WOULD NOT ALLOW FOR COMPLETE OFF POSITION. THERE WAS NO DAMAGE NOTED TO THE DEVICE CUTTER. THE DEVICE WAS REMOVED FROM THE PATIENT FOR INSPECTION. NO VESSEL DAMAGE WAS NOTED. A LARGE PLAQUE WAS REMOVED FROM THE DEVICE. ADDITIONALLY, THERE WAS SOME WIRED BLUE COLOURED STRING LIKE MATERIAL IN THE CUTTER BLADE AND WITHIN THE FLUSH PORT. IT WAS INITIALLY THOUGH IT WAS TOWEL BUT THE TOWEL WAS NOT NEAR WHEN THE DEVICE WAS REMOVED AND HAD NOT COME INTO CONTACT WITH THE DEVICE. POSSIBLY SHEATH LINING. THE PROCEDURE WAS THEN COMPLETED BY PTA AND DCB. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10933729 ↗
• MalfunctionNov 12, 2020Difficult to Insert; Detachment of Device or Device Component; Difficult to Insert; Detachment of Device or Device Component

  PHYSICIAN USED HAWKONE DIRECTIONAL ATHERECTOMY ALONG WITH 7FR SHEATH, A NON-MEDTRONIC GUIDEWIRE AND 6MM EMBOLIC PROTECTION DURING PROCEDURE TO TREAT A MODERATELY CALCIFIED LESION IN THE MID TO DISTAL LEFT SUPERFICIAL FEMORAL ARTERY (SFA) WITH CHRONIC TOTAL OCCLUSION (CTO-100%). THE VESSEL DIAMETER WAS 6MM. THE VESSEL WAS NOT PRE OR POST DILATED. IFU WAS FOLLOWED. DURING WITHDRAWAL, SEVERE RESISTANCE WAS FELT AND THE TIP DETACHED/DAMAGED. THE HAWKONE TIP WAS STUCK INSIDE THE SHEATH PULLING THE SPIDER WITH IT. PHYSICIAN WAS UNABLE TO TAKE FINAL PICTURES TO ASSESS DAMAGE AFTER LOSING WIRE. ULTRASOUND WILL BE PERFORMED IN THE AFTERNOON POST PROCEDURE. PHYSICIAN WAS UNABLE TO COMPLETE, ACCESS WAS LOST. PATIENT COMPLICATION ASSOCIATED WITH THIS EVENT IS ACCESS SITE HEMORRHAGE/BLEED. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10828322 ↗
• MalfunctionNov 3, 2020Difficult to Advance; Difficult to Advance

  PHYSICIAN WAS ATTEMPTING TO USE A HAWKONE DIRECTIONAL ATHERECTOMY DURING PROCEDURE TO TREAT A LITTLE CALCIFIED PLAQUE LESION IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA) WITH 80% STENOSIS. THE LESION WAS LITTLE TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH ARE 6MM AND 150MM RESPECTIVELY. A SPIDER WIRE 5.0 FILTER WAS USED AS THE GUIDEWIRE. THE WIRE WAS HYDRATED DURING PREP. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. RESISTANCE WAS FELT DURING ADVANCEMENT OF THE DIRECTIONAL ATHERECTOMY DEVICE OVER THE GUIDEWIRE. IT WAS REPORTED THAT WIRE WRAP OCCURRED DURING THE SECOND ADVANCEMENT. THE DEVICE WAS ADVANCED OVER THE BIFURCATION. THE WIRE WRAP DID NOT CAUSE TIP DAMAGE. BOTH DEVICES WERE SAFELY REMOVED FROM THE PATIENT. THE CUTTER COULD NOT BE RETRACTED ALL OF THE WAY INTO THE HOUSING AND WAS REPORTED TO BE BETWEEN INSIDE AND OUTSIDE OF THE HOUSING AND WAS NOT RETRACTED ALL THE WAY INTO THE HOUSING DURING DEVICE REMOVAL. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10776570 ↗
• MalfunctionAug 20, 2020Mechanical Jam; Physical Resistance/Sticking; Mechanical Jam; Physical Resistance/Sticking

  PHYSICIAN ATTEMPTED TO USE A HAWKONE ATHERECTOMY DEVICE DURING TREATMENT OF A 250MM SOFT TISSUE CTO (CHRONIC TOTAL OCCLUSION-100%) IN THE PATIENT¿S MID RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). SLIGHT VESSEL TORTUOSITY AND CALCIFICATION ARE REPORTED. VESSEL DIAMETER REPORTED AS 6MM. THE DEVICE WAS INSPECTED PRIOR TO USE WITHOUT ISSUE. IFU WAS FOLLOWED. IT IS REPORTED THAT THE DEVICE JAMMED AND WOULD NOT CLOSE DURING USE. THE CUTTER COULD NOT CLOSE ALL THE WAY INTO THE HOUSING UPON DEVICE REMOVAL FROM THE PATIENT. THE DEVICE WAS SAFELY REMOVED. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10429888 ↗
• MalfunctionJun 23, 2020Material Deformation; Material Deformation

  PHYSICIAN INTENDED TO USE A HAWKONE ATHERECTOMY DEVICE WITH A 7FR SHEATH AND 0.014 GUIDEWIRE DURING TREATMENT OF A CALCIFIED LESION IN THE PATIENT¿S PROXIMAL LEFT SUPERFICIAL FEMORAL ARTERY (SFA). MODERATE VESSEL CALCIFICATION IS REPORTED. PRE-DILATION WAS PERFORMED. TIP DAMAGE IS REPORTED. THE NOSECONE IS REPORTED AS DAMAGED. NO SEPARATION OCCURRED AT THE HINGE PIN. THE DEVICE WAS USED TO TREAT THE PATIENT BEFORE TIP DAMAGE WAS NOTED. NO COMPONENTS DETACHED. IT IS UNKNOWN IF ANY CHIPS WERE MISSING FROM THE CUTTER. THE DEVICE WAS REMOVED FROM THE PATIENT WITHOUT ISSUE. IT IS UNKNOWN THE POSITION OF THE CUTTER DURING DEVICE REMOVAL FROM THE PATIENT. THERE WAS NO VESSEL DAMAGE NOTED. THE PROCEDURE WAS ENDED WITH REMOVAL OF THE ARTERIAL SHEATH INTACT WITH THE SITE SEALED WITH MANUAL COMPRESSION, THERE WAS NO FURTHER PATIENT TREATMENT REQUIRED. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10184294 ↗
• InjuryMay 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PHYSICIAN USED A HAWKONE DIRECTIONAL ATHERECTOMY DEVICE ALONG WITH A NON MEDTRONIC 7FR SHEATH, A 0.014 GUIDE WIRE AND SPIDER FX 7MM EMBOLIC PROTECTION TO TREAT SEVERELY CALCIFIED FIBROUS PLAQUE LESION IN THE RIGHT MID SFA WITH 95% STENOSIS. THE VESSEL DIAMETER WAS 6MM AND 40MM RESPECTIVELY. THE VESSEL WAS LITTLE TORTUOUS. THE VESSEL WAS NOT PRE DILATED BUT POST DILATED. IFU WAS FOLLOWED. IT WAS REPORTED THAT UPON REMOVING THE HAWKONE DEVICE, PERFORATION AND FISTULA FORMATION WAS NOTED. PHYSICIAN THEN CHOSE TO PLACE A 7X100 NON MEDTRONIC STENT TO COVER INJURED AREA AND POST DIALATED WITH A 6X40 PTA BALLOON. THE POST PROCEDURE IMAGES SHOWED PATIENT VESSEL AND DOPPLER PULSES.

  Patient problems: Perforation

  MAUDE report 10101270 ↗
• MalfunctionDec 16, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN WAS USING A HAWKONE DIRECTIONAL ATHERECTOMY DURING A PROCEDURE TO TREAT COMMON FEMORAL AND SFA. THE LESION LENGTH WAS 45CM. THE ILIAC VESSEL WAS VERY TORTUOUS. IT WAS REPORTED THAT UPON REMOVAL FOR THE FIRST CLEANING, THE DEVICE WOULD NOT CLOSE COMPLETELY. IT WAS DETERMINED THAT THE INNER LINER OF THE TIP HAD SEPARATED FROM THE REST OF THE TIP. NO PARTS OF THE DEVICE WERE MISSING WHEN REMOVED FROM THE PATIENT. IT WAS REPORTED THE CUTTER FAILED TO CLOSE ALL OF THE WAY INTO THE TIP WHEN RETRIEVED FOR CLEANING. THE PROBLEM PRESENTED ITSELF AS AN INABILITY TO CLOSE THE CUTTER ALL OF THE WAY INTO THE TIP WHEN RETRIEVING IT FOR CLEANING. THE BLADE OF THE DEVICE WOULD NOT EXTEND FULLY INTO THE TIP, BUT WAS PROTECTED ON THE WAY OUT THERE WAS NO PATIENT IMPACT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9473459 ↗