HawkOne H1-LSRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00821684057926), received between Apr 24, 2017 and Mar 30, 2020 — classified as 5 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (8 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryMar 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HAWKONE DEVICE WAS USED TO TREAT A 20MM CALCIFIED LESION IN THE PATIENTS¿ MID SUPERFICIAL FEMORAL ARTERY (SFA) OF DIAMETER 7MM. LESION EXHIBITED 80% STENOSIS. SLIGHT VESSEL TORTUOSITY AND SEVERE VESSEL CALCIFICATION REPORTED. PRE-DILATION WAS NOT PERFORMED. NO ISSUES REPORTED DURING USE OF THE DEVICE. FOUR PASSES WERE COMPLETED, AND IT IS REPORTED THE ARTERY DIAMETER HAD INCREASED LARGER THAN BASELINE. ANGIOPLASTY WAS PERFORMED USING AN INPACT ADMIRAL DCB AND PATIENT WAS DISCHARGED FROM HOSPITAL. ROUTINE FOLLOW-UP HAS SHOWN THE COMMON FEMORAL CONTINUING TO INCREASE. ALMOST 2 YEARS POST-PROCEDURE, THE VESSEL IS REPORTED TO NOW BE APPROXIMATELY 2.5 CM IN DIAMETER. PATIENT IS REPORTED TO HAVE ANEURYSM OF COMMON FEMORAL ARTERY. THE HAWKONE IS SUSPECTED TO HAVE BEEN A CONTRIBUTOR TO THE EVENT. PATIENT WAS REFERRED TO VASCULAR SURGEON.

  Patient problems: Aneurysm

  MAUDE report 9896689 ↗
• MalfunctionNov 22, 2018Fracture; Fracture

  IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO USE A HAWKONE LS TO TREAT A MODERATELY CALCIFIED LESION WITH 70% STENOSIS IN THE MID RIGHT SUPERFICIAL FEMORAL ARTERY(SFA). ARTERY DIAMETER AND LESION LENGTH WERE REPORTED AS 7MM AND 80MM, RESPECTIVELY. PHYSICIAN USED A NON-MEDTRONIC 7FR SHEATH AND A 0.014 SPIDER FILTER. THE IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. IT WAS REPORTED THAT THE THUMB SWITCH MALFUNCTIONED WITH SPRING LIKE PROTRUSION SEEN IN FRONT OF THUMB SWITCH. THE PHYSICIAN MADE 2 PASSES; DEVICE WAS CLEANED AND REINSERTED. UPON ATTEMPTING TO TURN DEVICE ON TO CONTINUE ATHERECTOMY, THE THUMB SWITCH WOULDN¿T MOVE AND AN OBJECT WAS PROTRUDING IN FRONT OF THUMB SWITCH AT THE BASE WAS SEEN. THE CATHETER DID NOT EXPERIENCE DIFFICULTY LOCKING INTO OR RELEASING FROM THE CUTTER DRIVER. THE THUMB-SWITCH WAS HELD FORWARD BUT IT IS UNKNOWN IF THE BLADE RETURNED FULLY TO THE HOUSING FOR REMOVAL FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW HAWKONE LS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8098633 ↗
• MalfunctionJul 20, 2018Failure to Power Up; Use of Device Problem; Mechanical Jam; Use of Device Problem

  THE PHYSICIAN WAS ATTEMPTING TO USE A HAWKONE DIRECTIONAL ATHERECTOMY CATHETER TO TREAT A MODERATELY CALCIFIED FIBROUS LESION IN THE RIGHT PROXIMAL/DISTAL SUPERFICIAL FEMORAL ARTERY. THE VESSEL HAD LITTLE TORTUOSITY. THE LESION HAD RESULTED IN 60% STENOSIS IN THE VESSEL. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. WHILE TRYING TO TURN OFF DEVICE AND PACK THE NOSE CONE THE DEVICE JAMMED AND WOULD NOT CLOSE. THE DEVICE WOULD TURN OFF BUT THE CUTTER WOULD NOT ADVANCE INTO THE NOSECONE. THE CUTTER WAS OUTSIDE THE HOUSING IN THE CUTTING POSITION WHEN IT STOPPED FUNCTIONING INSIDE THE PATIENT. MULTIPLE ATTEMPTS WERE MADE TO PACK DEVICE AND ADVANCE CUTTER INTO NOSE CONE. EVENTUALLY THE THUMB SWITCH ADVANCED FORWARD BUT THE BLADE/ PACKER DID NOT MOVE. IT WAS REPORTED A METAL ROD BOWED UP IN FRONT OF THUMB SWITCH. NO DEFORMATION WAS NOTED TO THE CUTTER. THE DEVICE WAS SAFELY REMOVED AND INSPECTED. THE DEVICE WAS NO LONGER FUNCTIONAL AND SWITCHED DEVICES TO COMPLETE CASE.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7705908 ↗
• MalfunctionJul 20, 2018Material Deformation; Material Protrusion/Extrusion; Physical Resistance/Sticking; Material Deformation

  THE PHYSICIAN WAS USING ONE HAWKONE DEVICE TO TREAT A 4CM SEVERELY CALCIFIED, MODERATELY TORTUOUS, FIBROUS PLAQUE IN THE RIGHT PROXIMAL POPLITEAL ARTERY LESION, EXHIBITING 95% STENOSIS. A 6FR NON-MEDTRONIC SHEATH WAS PLACED IN THE LEFT FEMORAL ARTERY FOLLOWED BY CONTRA 2 AND 145 J WIRE CONTRALATERAL. THE CATHETER WAS REMOVED, AND THE SHEATH EXCHANGED FOR A FOR A 7FR 45CM NON-MEDTRONIC SHEATH. A NON-MEDTRONIC 0.014 300CM GUIDEWIRE WAS ALSO USED DURING THE PROCEDURE. THE PHYSICIAN PERFORMED AN ANGIOGRAM OF THE LESION. A NON-MEDTRONIC 0.014 300MM GUIDEWIRE WAS INSERTED AND SUCCESSFULLY CROSSED THE LESION. THE LESION WAS NOT PREDILATED. THE IFU WAS FOLLOWED DURING THE PROCEDURE. NO RESISTANCE WAS FELT DURING ADVANCEMENT DURING THE PROCEDURE THE PHYSICIAN MADE 8-9 SUCCESSFUL PASSES WITH THE HAWKONE. UPON REMOVAL FROM THE ARTERY THE PHYSICIAN FELT RESISTANCE AT THE DISTAL TIP OF THE SHEATH. UNDER FLOURO GUIDANCE THE PHYSICIAN WAS ABLE TO PULL THE DEVICE WITHOUT LOSING THE GUIDEWIRE OR SHEATH PLACEMENT. IT WAS REPORTED THAT THE PAC MAN PACKER WAS DAMAGED DURING THE PROCEDURE BUT DID NOT APPEAR FULL WHILE MAKING THE PASSES. IT WAS NOT DIFFICULT TO TURN OFF. THE FLUSH PORT ON THE HANDLE SHO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7705604 ↗
• MalfunctionJun 20, 2018Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE A 7F HAWKONE WITH A NON-MEDTRONIC 7FR SHEATH AND A NON-MEDTRONIC 0.014 GUIDE WIRE AS PER THE IFU TO TREAT A 60% STENOTIC LESION IN THE LEFT MID POPLITEAL ARTERY. THE LESION WAS REPORTED AS 80MM IN LENGTH, PLAQUE AND HAVING LITTLE CALCIFICATION. THE VESSEL DIAMETER WAS REPORTED AS 6MM. IT WAS REPORTED THAT DURING THE PROCEDURE THE PHYSICIAN ENCOUNTERED DIFFICULTY REMOVING THE DEVICE FROM THE PATIENT AND DAMAGE WAS OBSERVED TO THE SIDE OF THE CATHETER WITH PLAQUE BUILD UP. THE PHYSICIAN WAS UNABLE TO FLUSH THE TISSUE. THE PROCEDURE WAS COMPLETED USING ANGIOPLASTY. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7620784 ↗
• InjuryMay 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PHYSICIAN USED A HAWKONE DEVICE FOR TREATMENT OF A 10MM VERY CALCIFIED NON-CTO LESION IN THE PROXIMAL RIGHT COMMON ILIAC ARTERY. THE DIAMETER WAS NOTED AS 8-9MM. THE VESSEL WAS REPORTED TO BE MODERATELY TORTUOUS. THE DEVICE WAS PREPPED AS PER IFU WITHOUT ANY ISSUE. THE PROCEDURE WAS CARRIED OUT SUCCESSFULLY. IT WAS REPORTED, 2 WEEKS POST PROCEDURE, IN A FOLLOW-UP VISIT, THAT A PSEUDO ANEURYSM WAS DETECTED VIA ULTRASOUND. PATIENT WAS BROUGHT BACK FOR A NON-MDT COVERED STENT. THE PATIENT IS REPORTED TO BE DOING WELL.

  Patient problems: Pseudoaneurysm

  MAUDE report 7525124 ↗
• MalfunctionMay 14, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  PHYSICIAN USED A HAWKONE DEVICE FOR THE TREATMENT OF A LESION IN THE LEFT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). IT IS REPORTED THE CATHETER WAS ACTING LIKE IT WAS FULL, MOTOR KEPT TURNING ON, UNLESS FORWARD PRESSURE WAS MAINTAINED. THE THUMBSWITCH WAS HELD FORWARD BUT THE CUTTER DID NOT STOP. UNABLE TO DETERMINE IF THERE WAS ANY DEFORMATION NOTED IN THE CUTTER OR PIECES MISSING. A NEW CATHETER WAS OPENED AND USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7509968 ↗
• MalfunctionApr 25, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PHYSICIAN INTENDED TO USE THE HAWKONE WITH A SPIDER FX TO TREAT A CTO, WITH MODERATE PLAQUE, SOFT TISSUE CALCIFICATION, WITH LITTLE TORTUOSITY IN THE RIGHT PROXIMAL POPLITEAL ARTERY AS PER IFU. THERE WERE NO ABNORMALITIES IN RELATION TO ANATOMY. ARTERY LENGTH WAS 5.5MM, LESION LENGTH WAS 150MM. IT WAS REPORTED THE HAWKONE WAS REMOVED FROM THE PATIENT OVER THE GUIDEWIRE, TO CLEAN THE DEVICE WITH NO ISSUES NOTED. THE PHYSICIAN ENCOUNTERED DIFFICULTY REINSERTING THE DEVICE BACK INTO THE PATIENT, WHILST ADVANCING THE DEVICE, THE DEVICE BECAME STUCK IN THE 7FR NON MEDTRONIC SHEATH AND THE WIRE APPEARED TO BE COMING OUT OF THE WIRE LUMEN EARLY. THE HAWKONE AND SPIDER FX WERE REMOVED FROM THE PATIENT AS A UNIT. THE TURBOHAWK LX WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT SYMPTOMS, COMPLICATIONS OR PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7457882 ↗
• MalfunctionMar 23, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PHYSICIAN INTENDED TO USE A HAWKONE DEVICE DURING TREATMENT OF A SEVERELY CALCIFIED LESION IN THE MID SUPERFICIAL FEMORAL ARTERY. THE VESSEL WAS DESCRIBED AS BEING SLIGHTLY TORTUOUS. THE DEVICE WAS PREPPED AS PER IFU WITHOUT ISSUE. IT IS REPORTED THE NOSECONE SEPARATED FROM THE DRIVESHAFT. IT WAS REPORTED THAT IT WAS POSSIBLE TO TURN OF THE THUMBSWITCH. THE CUTTER DRIVER THUMBSWITCH DID NOT STOP FUNCTIONING WHILE IN USE IN THE PATIENT. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. NO DEFORMATION NOTED IN THE CUTTER. THIS ISSUE WAS IDENTIFIED ON THE SECOND INSERTION OF THE DEVICE. NO PATIENT INJURY REPORTED. THE DEVICE WAS REPLACED WITH ANOTHER TO FINISH THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7365503 ↗
• MalfunctionMar 15, 2018Device Operates Differently Than Expected; Material Deformation; Device Operates Differently Than Expected; Material Deformation

  PHYSICIAN USED A HAWKONE DEVICE FOR THE TREATMENT OF A 75% STENOSED MODERATELY CALCIFIED PLAQUE LESION IN THE DISTAL LEFT SUPERFICIAL FEMORAL ARTERY (SFA). DEVICE WAS PREPPED AS PER IFU WITHOUT ISSUE. IT IS REPORTED THAT A LONG PIECE OF PLAQUE WAS NOTED COMING OUT OF THE SIDE (MEC TECHNOLOGY) OF THE NOSECONE UPON REMOVAL OF DEVICE FROM SHEATH PRIOR TO CLEANING THE DEVICE. THE NOSECONE APPEARED TO BE 3/4 FULL PRIOR TO REMOVING FOR CLEANING SO IT WAS NOT OVER PACKED. PHYSICIAN WAS CONCERNED THAT PLAQUE WAS COMING OUT OF THE SIDE OF NOSECONE. THERE WERE NO ADVERSE EVENTS OR EMBOLI NOTED DISTAL TO TREATMENT AREA. PROCEDURE COMPLETED WITH THIS DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7341880 ↗
• MalfunctionFeb 1, 2018Break; Break

  PHYSICIAN INTENDED TO USE A HAWKONE DEVICE FOR TREATMENT OF AN UNKNOWN VESSEL. DEVICE WAS PREPPED AS PER IFU WITHOUT ISSUE. IT IS REPORTED THERE WAS A BREAK DURING THE PROCEDURE. AWAITING FOLLOW-UP INFORMATION. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7234474 ↗
• InjuryDec 21, 2017Material Deformation; Material Deformation

  THE PHYSICIAN WAS ATTEMPTING TO USE A HAWKONE DIRECTIONAL ATHERECTOMY DEVICE TO TREAT A 150MM PLAQUE LESION WITH LITTLE CALCIFICATION IN THE PROXIMAL SFA. THE VESSEL HAD A DIAMETER OF 6.5MM AND HAD LITTLE TORTUOSITY. THE LESION HAD 80% STENOSIS. THE PROCEDURE USED A 7 FR NON-MEDTRONIC SHEATH AND A NON-MEDTRONIC 300MM GUIDEWIRE. THE VESSEL WAS PRE- BUT NOT POST DILATED. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT THE NOSECONE OF THE DEVICE WAS BULGING WITH PLAQUE. THE NOSECONE WAS INTACT ASIDE FROM THE BULGE. THE DEVICE HAD NOT BEEN OVER PACKED. THE SAME ISSUE OCCURRED WITH A SECOND HAWKONE DEVICE. THE CUTTER DRIVER/THUMBSWITCH DID NOT STOP FUNCTIONING WHILE IN USE IN PATIENT. THE ATHERECTOMY PROCEDURE CAUSED A DISSECTION IN THE VESSEL. A 6MM PROTEGE STENT WAS USED TO COMPLETE THE PROCEDURE DUE TO THE DISSECTION. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Intimal Dissection

  MAUDE report 7138248 ↗
• InjuryDec 18, 2017Material Deformation; Material Deformation

  THE PHYSICIAN WAS ATTEMPTING TO USE A HAWKONE DIRECTIONAL ATHERECTOMY DEVICE TO TREAT A 150MM PLAQUE LESION WITH LITTLE CALCIFICATION IN THE PROXIMAL SFA. THE VESSEL HAD A DIAMETER OF 6.5MM AND HAD LITTLE TORTUOSITY. THE LESION HAD 80% STENOSIS. THE PROCEDURE USED A 7 FR NON-MEDTRONIC SHEATH AND A NON-MEDTRONIC 300MM GUIDEWIRE. THE VESSEL WAS PRE- BUT NOT POST DILATED. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT THE NOSECONE OF THE DEVICE WAS BULGING WITH PLAQUE. THE DEVICE HAD NOT BEEN OVER PACKED. A STENT WAS USED TO COMPLETE THE PROCEDURE DUE TO DISSECTION. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Intimal Dissection

  MAUDE report 7127851 ↗
• MalfunctionNov 23, 2017Material Deformation; Material Deformation

  THE PHYSICIAN WAS ATTEMPTING TO USE A HAWKONE ATHERECTOMY DEVICE TO TREAT A 80 CM FIBROUS CHRONIC TOTAL OCCLUSION WITH LITTLE CALCIFICATION IN THE MID LEFT SFA. THE DIAMETER OF THE ARTERY WAS 6 MM. THE PROCEDURE USED A SPIDER 6MM GUIDEWIRE AND A 7 FR COMPETITOR SHEATH. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. PLAQUE RUPTURED THROUGH NOSECONE WHEN PACKED. NO INTERVENTION WAS REQUIRED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7056785 ↗
• MalfunctionNov 23, 2017Material Deformation; Material Deformation

  THE PHYSICIAN INTENDED TO USE THE HAWKONE 7F TO TREAT THE SUPERFICIAL FEMORAL/ POPLITEAL ARTERY, AS PER IFU. IT WAS REPORTED THE PHYSICIAN ENCOUNTERED DIFFICULTY REMOVING THE DEVICE FROM THE 45CM DESTINATION SHEATH. THE DEVICE WAS REMOVED FROM THE PATIENT WITH NO INJURY NOTED, MATERIAL WAS OBSERVED PROTRUDING FROM THE SIDE WALL OF THE NOSECONE. NO INJURY TO THE PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7056779 ↗
• InjuryAug 17, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PHYSICIAN USED A HAWKONE DIRECTIONAL ATHERECTOMY DEVICE WITH A 7 FR SHEATH AND 7 MM EMBOLIC PROTECTION DEVICE FOR THE TREATMENT OF A 100 MM MODERATELY CALCIFIED LESION IN THE PROXIMAL LEFT SFA OF DIAMETER 5-6 MM. LESION EXHIBITED CHRONIC TOTAL OCCLUSION (CTO). IFU WAS FOLLOWED. PROCEDURE COMPLETED AS NORMAL. IT WAS REPORTED THAT ATHERECTOMY WITH POST DILATION SHOWED GOOD RESULT WITH SLIGHT APPEARING PSEUDO ANEURYSM. DURING THE RECOVERY PERIOD, PATIENT REPORTED INCREASED GROIN PAIN; ULTRASOUND SHOWED AN INCREASE IN THE SIZE OF PSEUDOANEURYSM; THEREFORE, THE PATIENT WAS SENT TO HOSPITAL. PATIENT WAS ADMITTED TO THE HOSPITAL AND MONITORED FOR PAIN AND ANY FURTHER POSSIBLE ISSUES. PATIENT WAS ALSO TREATED WITH A NON-MEDTRONIC STENT (7 MM X 5 CM/8 MM X 5 CM) TO COVER THE LESION.

  Patient problems: Pseudoaneurysm

  MAUDE report 6802749 ↗
• MalfunctionJul 18, 2017Device Damaged by Another Device; Device Damaged by Another Device

  PHYSICIAN USED A HAWKONE DIRECTIONAL ATHERECTOMY DEVICE WITH A 7 FR SHEATH AND A NON-MEDTRONIC GUIDEWIRE FOR THE TREATMENT OF A SLIGHTLY TORTUOUS, MODERATELY CALCIFIED 300MM PLAQUE/SOFT TISSUE LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY OF DIAMETER 6MM. IFU (INSTRUCTION FOR USE) FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE. GUIDEWIRE WAS HYDRATED AT PREPARATION. DEVICE WAS ADVANCED OVER BIFURCATION. VESSEL WAS NOT PRE-DILATED. IT WAS REPORTED THAT SEVERE RESISTANCE WAS FELT DURING WITHDRAWAL. THE GUIDEWIRE LOCKED-UP ON THE CATHETER. THE GUIDEWIRE LUMEN WAS TORN FROM THE DISTAL TIP. IT IS REPORTED THAT EVERYTHING WAS VERY TANGLED AND IT WAS DIFFICULT TO TELL WHAT TOOK PLACE BUT EVERYTHING WAS REMOVED IN TANDEM. PRESSURE WAS HELD UNTIL A NEW SHEATH COULD BE INSERTED TO COMPLETE THE PROCEDURE SUCCESSFULLY. VESSEL WAS POST-DILATED. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6723307 ↗
• MalfunctionJul 13, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  PHYSICIAN USED A HAWKONE DIRECTIONAL ATHERECTOMY DEVICE FOR THE TREATMENT OF A SLIGHTLY TORTUOUS, MODERATELY CALCIFIED FIBROUS LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). DEVICE WAS INSPECTED BEFORE USE WITH NO ISSUES NOTED. DEVICE WAS PREPPED WITHOUT ANY ISSUE IDENTIFIED. IT WAS REPORTED THAT AFTER THE FIRST INSERTION, THE DEVICE WAS REMOVED AND CLEANED. DURING CLEANING, THE TECHNICIAN NOTED A STRING OF PLASTIC THAT FLUSHED OUT WITH THE TISSUE. WHEN THE OPERATOR WISHED TO PERFORM ADDITIONAL ATHERECTOMY, ANOTHER HAWKONE LS WAS OPENED AND USED. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6712969 ↗
• MalfunctionJun 28, 2017Material Puncture/Hole; Material Puncture/Hole

  PHYSICIAN WAS USING A HAWKONE DEVICE FOR TREATMENT OF A MILDLY CALCIFIED LESION IN THE LEFT MID SUPERFICIAL FEMORAL ARTERY (SFA). DEVICE WAS INSPECTED PRIOR TO USE AND PREPPED AS PER IFU WITHOUT ISSUE. HAWKONE WAS PUT INTO THE PATIENT¿S BODY ONCE AND COMPLETED SEVERAL PASSES WITH IT. IT WAS REPORTED THAT WHEN IT WAS TAKEN OUT FOR CLEANING, THERE WAS PLAQUE COMING OUT THE SIDE OF THE (METAL) PART OF THE CATHETER. IT WAS POSSIBLE TO TURN OFF THE THUMBSWITCH AND THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. ON CLOSER INSPECTION, IT WAS OBSERVED THAT THERE WAS A HOLE IN THAT AREA OF THE DEVICE, AND IT COULD NOT BE USED A SECOND TIME. THE PROCEDURE WAS SUCCESSFUL COMPLETED USING ANOTHER LS DEVICE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6675908 ↗
• MalfunctionJun 2, 2017Material Deformation; Material Deformation

  PHYSICIAN WAS USING A HAWKONE ATHERECTOMY DEVICE WITH A 7FR SHEATH AND .014 GUIDE WIRE AND EMBOLIC PROTECTION DEVICE OF SIZE 6MM FOR THE TREATMENT OF A MODERATELY CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY. LESION WAS MODERATELY CALCIFIED WITH AN AREA OF HEAVY CALCIUM AT THE ADDUCTOR CANAL. NO TORTUOSITY. POST DILITATION WAS ACCOMPLISHED WITH A 6MM IN.PACT BALLOON. DEVICE WAS PREPPED AS PER IFU WITHOUT ISSUE. IT WAS REPORTED THAT AFTER SECOND INSERTION OF THE DEVICE, DIFFICULTY WAS ENCOUNTERED WHEN TRYING TO GET THE THUMB SWITCH TO ADVANCE AND THE DEVICE TO TURN OFF. DEVICE WAS REPORTEDLY PERFORMING AS EXPECTED WITH NO ISSUES PRIOR TO THIS. PHYSICIAN HELD THE THUMB SWITCH FORWARD TURNING OFF THE DEVICE BUT NOT ENOUGH TO SEE THE CUTTER IN THE NOSECONE, REMOVING IT FROM THE PATIENT SUCCESSFULLY WITH NO ADVERSE PATIENT EFFECTS REPORTED. THERE WAS NO DEFORMATION OF THE NOSECONE NOTICED AT THE TABLE. PROCEDURE WAS COMPLETED TO PHYSICIAN¿S SATISFACTION. NO PATIENT INJURY REPORTED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6610090 ↗
• MalfunctionApr 24, 2017Difficult to Remove; Difficult to Remove

  PHYSICIAN ATTEMPTED TO TREAT A MODERATELY CALCIFIED LESION IN THE RIGHT SFA, POPLITEAL AND POSTERIOR TIBIAL ARTERY USING HAWKONE. A 7FR SHEATH WAS PLACED ANTEGRADE INTO THE RIGHT COMMON FEMORAL ARTERY. BMW WIRE ADVANCED TO THE TP TRUNK. SPIDERFX ADVANCED OVER BMW TO TP TRUNK THEN THE BMW WIRE WAS REMOVED AND THE SPIDER DEPLOYED. THE HAWKONE LS WAS ADVANCED OVER THE WIRE TO THE LESION IN MID SFA. A TOTAL OF 6 PASSES WERE MADE AND I NOTED TO PHYSICIAN THAT THE DEVICE SHOULD BE FULL AND NEEDED TO BE CLEANED PRIOR TO MAKING MORE PASSES. HOWEVER UNDER FLOURO THE PACKING MECHANISM DID NOT SHOW THE DEVICE WAS FULL YET. THE SCRUB TECH DID NOT INDICATE THAT IS WAS DIFFICULT TO PACK WHEN CLOSING THE CUTTER. 4 MORE PASSES WERE MADE TO THE DISTAL LESION. UPON TRYING TO REMOVE THE DEVICE THE PHYSICIAN FELT RESISTANCE IN THE SHEATH. UNDER FLUOROSCOPY PHYSICIAN CHECKED FOR WIRE WRAP/ PROLAPSE OF WIRE AND NONE WERE VISIBLE. SALES REP TOLD PHYSICIAN IT WAS MOST LIKELY OVER-PACKED. A STEELCORE 018 WIRE WAS PLACED IN INTO THE SHEATH ALONGSIDE THE SPIDER WIRE AND HAWK. THE DEVICE AND SHEATH WERE THEN REMOVED FROM THE BODY. AN 8FR SHEATH WAS THEN PLACED OVER BOTH WIRES INTO THE INSERTION SITE. THE STEE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6515974 ↗