HawkOne™ H1-M (UDI 00643169792302)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00643169792302), received between Jul 12, 2017 and Dec 17, 2018 — classified as 7 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (10 reports).

1 FDA recall record name this device's identifier.

1 other recall cover devices cleared under the same FDA submission (K161361); they may or may not involve this specific model.

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.

Recalls naming this device

1. Dec 6, 2021Terminated

   Reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization.

   Z-0450-2022 · Root cause: Labeling design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryDec 17, 2018Detachment of Device or Device Component; Material Twisted/Bent; Detachment of Device or Device Component; Material Twisted/Bent

  PHYSICIAN USED A HAWKONE DEVICE DURING TREATMENT OF THE PATIENTS RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). IT TIS REPORTED THAT THE DEVICE FAILED TO WORK PROPERLY AND WAS UNABLE TO BE REMOVED FROM THE BODY IN THE WAY IT WENT IN. A SNARE WAS ATTEMPTED BY FAILED, BECAUSE DEVICE COULD NOT BE DISLODGED. A BILATERAL GROIN CUT DOWN HAD TO BE PERFORMED AND LOWER ACCESS BY THE RIGHT ANKLE. THE DEVICE DID BREAK IN THE BODY AND WAS RETRIEVED FROM THE AORTA. AN EMERGENCY CUT-DOWN WAS DONE TO RETRIEVE THE DEVICE UNDER FLUOROSCOPIC VISUALIZATION. IT WAS REPORTED THE 0.014 WIRE HAD GOTTEN TANGLED AROUND THE NOSECONE RESULTING MULTIPLE LOOPS AROUND THE TIP. THIS WAS IN THE MIDDLE OF THE WIRE AND AFTER THAT CONTINUED DOWN INTO THE SFA.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8169361 ↗
• InjuryDec 4, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PHYSICIAN USED A HAWKONE M WITH A 6F 45CM NON-MEDTRONIC SHEATH FOR TREATMENT OF A CALCIFIED/PLAQUE LESION IN THE PATIENTS RIGHT PROXIMAL COMMON ILIAC ARTERY. THE VESSEL WAS DESCRIBED AS SLIGHTLY CALCIFIED AND SLIGHTLY TORTUOUS. THE IFU WAS FOLLOWED AND THE HAWKONE M WAS PREPPED WITHOUT ISSUE. THE VESSEL WAS NOT PRE-DILATED. IT WAS REPORTED THAT SEVERE RESISTANCE WAS EXPERIENCED WHEN ATTEMPTING TO WITHDRAW THE DEVICE. THE WIRE WRAPPED AROUND THE NOSECONE OF THE HAWKONE M. THE NOSECONE BECAME BENT RESULTING IN TIP DETACHMENT. THE TIP WAS REPORTED TO HAVE SEPARATED AT THE HINGE PIN. THE GUIDEWIRE WAS REPORTED TO HAVE BEEN TORN FROM THE DISTAL TIP. TWO CUT DOWNS WERE CARRIED OUT TO REMOVE THE DETACHED PORTION. A NON-MEDTRONIC STENT WAS PLACED AND THE PROCEDURE WAS COMPLETED. THE PATIENT WAS REPORTED TO BE STABLE.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8128067 ↗
• InjuryNov 15, 2018Material Twisted/Bent

  FAILED MEDICAL DEVICE. DURING THE RIGHT LEG ANGIOGRAM/ATHERECTOMY DEVICE. COVIDIEN BY MEDTRONIC FAILED TO WORK PROPERLY AND WAS UNABLE TO BE REMOVED FROM THE BODY IN THE WAY IT WENT IN. SNARE WAS ATTEMPTED BUT FAILED, BECAUSE DEVICE COULD NOT BE DISLODGED. BILATERAL GROIN CUT DOWN HAD TO BE PERFORMED AND LOWER ACCESS BY THE RIGHT ANKLE. DEVICE DID BREAK IN THE BODY AND WAS RETRIEVED FROM THE AORTA. EMERGENCY CUT DOWN WAS DONE TO RETRIEVE THE DEVICE. UNDER FLUOROSCOPIC VISUALIZATION, ABLE TO SEE 0.014 WIRE HAD GOTTEN TANGLED AROUND THE NOSECONE RESULTING IN MULTIPLE LOOPS AROUND THE TIP. THIS WAS IN THE MIDDLE OF THE WIRE AND AFTER THAT CONTINUED DOWN INTO THE SFA.

  Patient problems: No Code Available

  MAUDE report 8079077 ↗
• MalfunctionJul 4, 2018Use of Device Problem; Use of Device Problem

  THE PHYSICIAN ATTEMPTED TO USE A HAWKONE WITH A 6FR TERUMO SHEATH & 3MM SPIDER TO TREAT A SEVERELY CALCIFIED LESION WITH LITTLE TORTUOSITY AND 99% STENOSIS IN THE MID LEFT POPLITEAL ARTERY AS PER THE IFU. NO PATIENT ABNORMALITIES WERE REPORTED. THE VESSEL WAS PRE AND POST DILATED. IT WAS REPORTED THAT AFTER PERFORMING 3 PASSES THE THUMB SWITCH WOULD NOT FULLY MOVE TO OFF POSITION AND THEREFORE WAS UNABLE TO PACK TISSUE. THE HAWKONE WAS REMOVED FROM THE PATIENT WITH THE CUTTER BLADE INSIDE THE HOUSING, ONCE REMOVED FURTHER ATTEMPTS TO TURN THE DEVICE TO THE OFF POSITION WERE UNSUCCESSFUL, NO VISIBLE DAMAGE TO THE CUTTER REPORTED. A NEW DEVICE WAS OPENED TO FINISH THE PROCEDURE WITH NO ISSUES NOTED. AT THE END OF PROCEDURE, FURTHER ATTEMPTS DID GET THE THUMB SWITCH TO FINALLY GO TO FULL OFF POSITION. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7662454 ↗
• MalfunctionJun 6, 2018Defective Device; Defective Device

  THE PHYSICIAN INTENDED TO USE A HAWKONE DEVICE WITH A NON-MDT SHEATH AND A NON-MDT .014 GUIDEWIRE FOR TREATMENT OF A 20MM CALCIFIED CTO (CHRONIC TOTAL OCCLUSION-100%) LESION IN THE PATIENT'S MID RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) (DIAMETER 6MM). MODERATE CALCIFICATION AND SLIGHT TORTUOSITY WAS REPORTED. THE IFU WAS FOLLOWED. IT IS REPORTED DURING THE PROCEDURE THAT RESISTANCE WAS FELT DURING ADVANCEMENT OF THE DEVICE AND THAT THE TIP OF THE DEVICE APPEARED DAMAGED. THE TIP DID NOT REQUIRE RETRIEVAL FROM THE PATIENT. UPON REMOVING THE DEVICE FROM THE PATIENT, THE PHYSICIAN NOTED THAT TISSUE HAD ADHERED TO THE SIDE OF THE NOSECONE. THE PROCEDURE WAS COMPLETED AS NORMAL AND POST-DILATION WAS CARRIED OUT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7573622 ↗
• MalfunctionMar 13, 2018Battery Problem; Difficult to Open or Close; Battery Problem; Difficult to Open or Close

  THE PHYSICIAN WAS USING A HAWKONE DEVICE WITH A NON-MDT 6FR SHEATH AND NON-MDT .014 GUIDEWIRE FOR THE TREATMENT OF A 60MM, 80% STENOSED PLAQUE LESION IN THE MID LEFT SUPERFICIAL FEMORAL ARTERY (SFA). THE VESSEL WAS DESCRIBED AS BEING NON-TORTUOUS AND THE ARTERY DIAMETER WAS 6MM. THE VESSEL WAS NOT PRE-DILATED. THE IFU WAS NOT FOLLOWED. THIS EVENT OCCURRED INTRASTENT AND THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED UNKNOWN STENT. IT IS REPORTED THE MOTOR OF THE HAWKONE DEVICE STOPPED RUNNING. THE THUMB SWITCH COULD BE TURNED OFF BUT THE CUTTER WAS POSITIONED OUTSIDE OF THE HOUSING. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT WITH NO DEFORMATION NOTED IN THE CUTTER AND AN ANGIOPLASTY WAS PERFORMED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7333400 ↗
• InjuryMar 8, 2018Detachment Of Device Component; Detachment Of Device Component

  THE PHYSICIAN INTENDED TO USE A HAWKONE 67F, 7F SHEATH AND 6.0 SPIDER FX, TO TREAT A MODERATELY TORTUOUS, CALCIFIED LESION, WITH 60-70% STENOSIS, IN THE PROXIMAL, MID AND DISTAL SUPERFICIAL FEMORAL ARTERY (5-6MM DIAMETER),. THE DEVICE WAS PREPARED AS PER IFU. IT WAS REPORTED THAT THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE REMOVING THE HAWKONE AND THE TIP OF THE DEVICE DETACHED. A VASCULAR CUT DOWN WAS PERFORMED TO REMOVE THE TIP OF THE HAWKONE FROM THE PATIENT.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7323813 ↗
• MalfunctionMar 2, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN EMPLOYED THE USE OF A HAWKONE DEVICE WITH 6FR NON-MDT SHEATH AND 7MM SPIDER FX EMBOLIC PROTECTION DEVICE FOR THE TREATMENT OF A SEVERELY CALCIFIED 40MM LESION IN THE PROXIMAL RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) OF DIAMETER 7MM. LESION EXHIBITED 80% STENOSIS. VESSEL REPORTED TO BE SEVERELY TORTUOUS. VESSEL WAS NOT PRE-DILATED. IFU WAS FOLLOWED. IT IS REPORTED DURING WITHDRAWAL OF THE DEVICE SEVERE RESISTANCE WAS EXPERIENCED AND THE TIP DETACHED AT THE HINGE PIN (SEPARATION OCCURRED FROM THE CUTTER AND NOSE CONE). THE ENTIRE SYSTEM WAS REMOVED FROM THE PATIENT WITH NO INTERVENTION REQUIRED NOR INJURY TO THE PATIENT. THE CUTTER WAS REPORTED TO HAVE BEEN OUTSIDE THE HOUSING DURING REMOVAL BUT WAS REMOVED SAFELY. THE PATIENT HAS BEEN DISCHARGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7308836 ↗
• MalfunctionFeb 22, 2018Material Deformation; Material Deformation

  THE PHYSICIAN WAS ATTEMPTING TO USE A HAWKONE DEVICE TO TREAT SEVERELY CALCIFIED LESIONS IN THE LEFT MID-DISTAL SFA AND POPLITEAL ARTERIES DESCRIBED AS EXHIBITING 70-80% STENOSIS. THE ARTERIES HAD NO TORTUOSITY AND A DIAMETER OF 6MM. THE LESION IN THE SFA WAS 30 MM AND THE POPLITEAL LESION WAS 20MM. THE VESSEL WAS NOT PRE-DILATED. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE PROCEDURE USED A 6 FR 11CM SHEATH AND A NON-MEDTRONIC 0.014" 180 CM GUIDEWIRE. AFTER THE LAST ROUND OF CUTTING THE PHYSICIAN WAS ATTEMPTING TO PULL BACK THE HAWKONE INTO THE SHEATH AND WAS FACED WITH MODERATE RESISTANCE DURING WITHDRAWAL. THE DEVICE BECAME STUCK IN THE SHEATH. THE DEVICE WAS EVENTUALLY REMOVED HOWEVER A PLASTIC PIECE OF THE NOSE CONE HAD SEPARATED FROM THE DISTAL END AND STAYED ATTACHED PROXIMALLY. THE TIP DID NOT SEPARATE AT THE HINGE POINT. THE VESSEL WAS POST-DILATED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7289084 ↗
• InjuryDec 19, 2017Retraction Problem; Detachment of Device or Device Component; Retraction Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PHYSICIAN EMPLOYED THE USE OF A HAWKONE ATHERECTOMY DEVICE WITH A NON-MEDTRONIC 6FR SHEATH, AN UNKNOWN MAKE OF A .014¿ GW AND A 6MM SPIDER FX EMBOLIC PROTECTION DEVICE FOR TREATMENT OF A SEVERELY CALCIFIED 80MM CTO LESION IN THE DISTAL SFA/POPLITEAL ARTERY. THE IFU WAS FOLLOWED. THE VESSEL WAS PRE-DILATED. IT WAS REPORTED THAT RESISTANCE WAS SEVERE DURING WITHDRAWAL OF THE DEVICE WHICH RESULTED IN A TIP DETACHMENT. THE SPIDER FX DID NOT DETACH BUT INSTEAD HAD TWO LOOPS THAT CAUSED THE WIRE TO KINK WHICH WOULD NOT LET THE HAWKONE PAST AND WAS HOLDING THE NOSE CONE FROM BEING REMOVED. THE NOSE CONE OF THE HAWKONE WAS STRIPPED OFF THE DEVICE. THE GUIDEWIRE LUMEN WAS TORN FROM THE DISTAL TIP. THE GUIDEWIRE DID NOT LOCK-UP ON THE CATHETER. THE PATIENT WAS TAKEN TO THE OPERATING ROOM(OR) AND A CUTDOWN AT THE FEMORAL HEAD WAS PERFORMED TO REMOVE THE DETACHED NOSE CONE AND THE SPIDER FX DEVICE. THE SPIDER FX WAS REMOVED AT THE SAME TIME AS THE NOSE CONE AS THE WIRE WAS DIRECTLY THROUGH THE CENTRE. IT WAS REPORTED THAT THE PATIENT IS RECOVERING WELL FROM THE OPEN PROCEDURE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7128220 ↗
• MalfunctionDec 13, 2017Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  THE PHYSICIAN WAS ATTEMPTING TO USE A HAWKONE DIRECTIONAL ATHERECTOMY DEVICE TO TREAT A MODERATELY CALCIFIED LESION IN THE MID SFA. THE VESSEL WAS MODERATELY TORTUOUS. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE PROCEDURE USED A 7 FR NON-MEDTRONIC SHEATH AND A NON-MEDTRONIC GUIDEWIRE. THE PHYSICIAN FELT MODERATE RESISTANCE WHEN WITHDRAWING THE HAWKONE AND WHEN IT WAS REMOVED FROM THE SHEATH IT WAS FOUND THE TIP WAS DETACHED AT THE HINGE PIN. ANOTHER HAWKONE WAS ATTEMPTED, HOWEVER THE SAME ISSUE REOCCURRED, I.E. THE TIP FOR THE SECOND HAWKONE WAS ALSO DETACHED AT THE HINGE PIN. THE PROCEDURE WAS COMPLETED USING BALLOON ANGIOPLASTY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7116204 ↗
• MalfunctionDec 13, 2017Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  THE PHYSICIAN WAS ATTEMPTING TO USE A HAWKONE DIRECTIONAL ATHERECTOMY DEVICE TO TREAT A MODERATELY CALCIFIED LESION IN THE MID SFA. THE VESSEL WAS MODERATELY TORTUOUS. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE PROCEDURE USED A 7 FR NON-MEDTRONIC SHEATH AND A NON-MEDTRONIC GUIDEWIRE. THE PHYSICIAN FELT MODERATE RESISTANCE WHEN WITHDRAWING THE HAWKONE AND WHEN IT WAS REMOVED FROM THE SHEATH IT WAS FOUND THE TIP WAS DETACHED AT THE HINGE PIN. ANOTHER HAWKONE WAS ATTEMPTED, HOWEVER THE SAME ISSUE REOCCURRED, I.E. THE TIP FOR THE SECOND HAWKONE WAS ALSO DETACHED AT THE HINGE PIN. THE PROCEDURE WAS COMPLETED USING BALLOON ANGIOPLASTY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7116202 ↗
• MalfunctionNov 30, 2017Device-Device Incompatibility; Device-Device Incompatibility

  THE PHYSICIAN WAS ATTEMPTING TO USE A HAWKONE DIRECTIONAL ATHERECTOMY DEVICE TO TREAT A 3 CM LESION IN THE SFA. THE ARTERY HAD A DIAMETER OF 5MM. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE GUIDEWIRE WAS HYDRATED DURING PREPARATION. THE PROCEDURE USED A 6FR NON-MEDTRONIC SHEATH AND A .014" NON-MEDTRONIC GUIDEWIRE. IT WAS REPORTED THAT NO RESISTANCE WAS EXPERIENCED WHEN THE HAWKONE WAS ADVANCED OVER THE BIFURCATION. IT WAS REPORTED THAT THE GUIDEWIRE BECAME STUCK ON THE CATHETER. THE HAWKONE AND THE GUIDEWIRE WERE REMOVED IN TANDEM. A NEW .014" NON-MEDTRONIC GUIDEWIRE WAS INTRODUCED AND BALLOON ANGIOPLASTY WAS PERFORMED SUCCESSFULLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7073578 ↗
• MalfunctionNov 28, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PHYSICIAN WAS ATTEMPTING TO USE A HAWKONE DIRECTIONAL ATHERECTOMY DEVICE TO TREAT AN 8 MM SEVERELY CALCIFIED LESION IN THE DISTAL SFA. THE VESSEL DIAMETER WAS 6.0 MM WITH LITTLE TORTUOSITY AND 60% STENOSIS. NO ABNORMALITIES WERE REPORTED IN RELATION TO THE PATIENT¿S ANATOMY. THE DEVICE WAS REMOVED FROM ITS PACKAGING AND INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED AS PER THE IFU. A 6 FR NON-MEDTRONIC SHEATH AND A 0.014" NON-MEDTRONIC GUIDEWIRE WERE USED DURING THE PROCEDURE. NO EMBOLIC PROTECTION WAS USED. THE VESSEL WAS NOT PRE-DILATED BUT WAS POST-DILATED. IT WAS REPORTED THAT SEVERE RESISTANCE WAS MET DURING WITHDRAWAL OF THE DEVICE. THE TIP OF THE DEVICE SEPARATED AT THE HINGE PIN DURING THE SECOND ADVANCEMENT. THE TIP WAS REMOVED WITHIN THE SHEATH. GUIDEWIRE PROLAPSE WAS REPORTED. A DISTAL KINK WAS NOTICED ON THE DEVICE AFTER THE SECOND ADVANCEMENT DURING REMOVAL OF THE SHEATH. THERE WAS A 5 MINUTES TIMELINE BETWEEN THE TIP DETACHING AND FINDING THE KINK. THE PROCEDURE WAS COMPLETED USING AN UNKNOWN STENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7065573 ↗
• MalfunctionNov 22, 2017Difficult to Flush; Delamination; Difficult to Flush; Delamination

  THE PHYSICIAN WAS ATTEMPTING TO USE A H1-M HAWKONE TO TREAT A PLAQUE LESION IN THE DISTAL SFA. THE LESION WAS 200 MM IN LENGTH WITH 80% STENOSIS. THE ARTERY DIAMETER WAS 5 MM WITH LITTLE TORTUOSITY. NO ABNORMALITIES WERE REPORTED IN RELATION TO THE PATIENT¿S ANATOMY. THE DEVICE WAS PREPPED AS PER THE IFU. A 6 FRENCH NON-MEDTRONIC SHEATH WAS USED IN THE PROCEDURE AND A .014¿ NON-MEDTRONIC GUIDEWIRE. NO EMBOLIC PROTECTION WAS USED. PROCEDURAL STROKE CINERADIOGRAPHY IMAGES ARE NOT AVAILABLE. PRE-DILATION OF THE VESSEL WAS NOT PERFORMED. POST-DILATION OF THE VESSEL WAS PERFORMED. THE PHYSICIAN DID NOT MEET RESISTANCE DURING ADVANCEMENT. THE PHYSICIAN WAS UNABLE TO FLUSH THE TISSUE AS TISSUE WAS TRAPPED IN THE NOSE CONE OF THE DEVICE, THE PHYSICIAN ATTEMPTED TO FLUSH THE DRIVESHAFT PORT AND THE FLUSH PORT ON THE CATHETER HANDLE BROKE. THE CUTTER WAS REPORTED AS DAMAGED. IN ADDITION, UPON CLEANING THE DEVICE IT WAS OBSERVED THAT THE NOSE CONE HAD STARTED TO BULGE. THE CUTTER WAS RETURNED INTO THE HOUSING. THE PHYSICIAN UTILISED H1-M HAWKONE TO COMPLETE THE PROCEDURE WITHOUT FURTHER COMPLICATION. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7052875 ↗
• InjuryNov 8, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PHYSICIAN WAS ATTEMPTING TO USE A HAWKONE DIRECTIONAL ATHERECTOMY DEVICE TO TREAT A CALCIFIED 5 CM LESION IN THE MID SFA. THE ARTERY WAS DESCRIBED AS HAVING LITTLE TORTUOSITY AND WAS 5MM. NO ABNORMALITIES WERE REPORTED IN RELATION TO THE PATIENT¿S ANATOMY. THE PROCEDURE USED A 0.014" NON-MEDTRONIC GUIDEWIRE AND A 6 FR NON-MEDTRONIC SHEATH. THE DEVICE WAS PREPPED AS PER THE IFU. NEITHER PRE- NOR POST-DILATION OF THE VESSEL WAS PERFORMED. THE PHYSICIAN DID NOT EXPERIENCE ANY RESISTANCE DURING ADVANCEMENT. IT WAS REPORTED THAT THE TIP OF THE DEVICE DETACHED PROXIMAL TO THE CUTTER. THE TIP WAS SNARED USING A GOOSENECK SNARE AND REMOVED THE PATIENT¿S VESSEL. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7012226 ↗
• InjuryOct 13, 2017Difficult to Remove; Difficult to Remove

  THE PHYSICIAN WAS ATTEMPTING TO USE A H1-M HAWKONE DIRECTIONAL ATHERECTOMY DEVICE TO TREAT A PLAQUE LESION WITH LITTLE CALCIFICATION IN THE RIGHT MID SFA. THE LESION WAS 60 MM IN LENGTH WITH 80% STENOSIS. THE ARTERY DIAMETER WAS 5 MM WITH NO TORTUOSITY. THE DEVICE WAS PREPPED AS PER THE IFU. A 6 FR 55CM NON-MEDTRONIC SHEATH WAS USED IN THE PROCEDURE. A 5 MM SPIDER FX EMBOLIC PROTECTION DEVICE WAS ALSO USED. THE VESSEL WAS NOT PRE-DILATED. NO RESISTANCE WAS EXPERIENCED DURING ADVANCEMENT. IT WAS REPORTED THAT AFTER TREATMENT WITH THE HAWKONE DEVICE, IT BECAME STUCK IN THE SHEATH UPON ATTEMPTING TO REMOVE IT FROM THE PATIENT, POST ATHERECTOMY TREATMENT. THE DEVICE WAS REMOVED BY HOLDING THE PRESSURE AND REMOVING IT TOGETHER WITH THE SPIDER DEVICE AND THE SHEATH. A DIFFERENT ACCESS SITE WAS OBTAINED USING ULTRASOUND GUIDED RT ANTEGRADE APPROACH VIA THE COMMON FEMORAL ARTERY TO COMPLETE THE PROCEDURE WITH A 5X6 IN.PACT ADMIRAL DCB. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6949097 ↗
• MalfunctionOct 11, 2017Material Deformation; Material Deformation

  THE PHYSICIAN WAS ATTEMPTING TO USE A HAWK ONE DIRECTIONAL ATHERECTOMY DEVICE TO TREAT A 200 MM PLAQUE LESION IN THE RIGHT SFA WITH LITTLE CALCIFICATION. THE ARTERY HAD NO TORTUOSITY WITH A DIAMETER OF 5 MM AND HAD 75% STENOSIS. NO ABNORMALITIES WERE REPORTED IN RELATION TO THE PATIENT¿S ANATOMY. THE PROCEDURE UTILIZED A 6 FR NON-MEDTRONIC SHEATH AND A 0.014" SPIDER GUIDEWIRE. THE VESSEL WAS NOT PRE-DILATED BUT WAS POST DILATED. THE IFU WAS FOLLOWED THROUGHOUT THE PROCEDURE. IT WAS REPORTED THAT THE DEVICE WORKED ON THE FIRST ADVANCE AND WAS CLEANED, BUT DURING THE SECOND ADVANCEMENT THE PHYSICIAN NOTICED THE BLADE WAS NOT IN ITS TYPICAL STARTING POSITION RADIOGRAPHICALLY. UPON INSPECTION OF THE DEVICE, THE BLADE WOULD NOT RETRACT AND PACK THE PLAQUE PROPERLY TO THE END OF THE NOSE CONE, THE DEVICE WAS NOT OPERATING CORRECTLY. IT WAS REPORTED THAT THE PHYSICIAN THINKS THERE WOULD BE AN INCREASED CHANCE OF EMBOLI DUE TO THE MECHANICAL PROBLEM. PLAQUE WAS STUCK IN THE PROXIMAL END OF THE NOSE CONE, AND THE BLADE COULD NOT FULLY RETRACT, LE AVING ALMOST NO ROOM TO EXTRACT AND PROPERLY COLLECT PLAQUE WITHIN THE DEVICE. THE CUTTER DRIVER COULD BE RETURNED TO THE HOUSING AND THE THUMB SW

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6939449 ↗
• MalfunctionJul 31, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN USED A HAWKONE DIRECTIONAL ATHERECTOMY DEVICE WITH A 6FR SHEATH AND .014 GUIDEWIRE FOR THE TREATMENT OF A 30 MM SLIGHTLY CALCIFIED; NON-TORTUOUS PLAQUE LESION IN THE RIGHT MID SUPERFICIAL FEMORAL ARTERY (SFA) OF DIAMETER 6 MM. LESION EXHIBITED 80% STENOSIS. DEVICE IFU WAS FOLLOWED. THE VESSEL WAS NOT PRE-DILATED. MODERATE RESISTANCE WAS FELT DURING WITHDRAWAL OF THE DEVICE. IT WAS REPORTED THAT UPON TRYING TO REMOVE THE HAWKONE DEVICE, THE WIRE TORE THROUGH THE WIRE CHANNEL AND WHEN DEVICE WAS REMOVED THROUGH THE SHEATH, THE TIP BROKE OFF. IT WAS REPORTED THE GUIDEWIRE PROLAPSE CAUSED THE TIP DAMAGE TO OCCUR. THE TIP DETACHED IN THE SFA JUST OUTSIDE THE SHEATH. NO INJURIES TO THE PATIENT OCCURRED. THE AREA WAS STENTED TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6755951 ↗
• MalfunctionJul 12, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN WAS USING A HAWKONE DIRECTIONAL ATHERECTOMY DEVICE WITH A 6 FR SHEATH AND 5 MM .014 SPIDER WIRE. DEVICE IFU WAS FOLLOWED. IT WAS REPORTED THAT THE PHYSICIAN HAD DIFFICULTY FULLY SLIDING THE THUMB SWITCH TO THE "OFF" POSITION. WHEN ATTEMPTING TO SLIDE THE CLEANING/FLUSH TOOL TO THE END OF THE CATHETER THERE WAS RESISTANCE, WHICH THEN LED TO THE PHYSICIAN PULLING HARDER AND THE DEVICE BREAKING (DAMAGE TO THE CENTER OF NOSE CONE - SEPARATION). NO COMPONENT NEEDED TO BE REMOVED FROM THE PATIENT. A NEW 6 FR HAWKONE WAS OPENED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6709746 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K161361. One submission often covers many models, so check the product and lot details in each record.

• Z-0451-2022 · Dec 6, 2021 · Terminated
  Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-S and H1-S-INT, Small Vessel, 6F (2.2 mm) Recommended sheath, 0.014" (0.36 mm) Compatible guidewire. The HawkO