SpiderFX™ SPD2-US-060-320Recalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 00821684068366), received between Apr 19, 2017 and Jun 30, 2026 — classified as 1 death, 28 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (32 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 57 reports, in the reporter's own words as published by the FDA.

• InjuryJun 30, 2026Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PERIPHERAL ARTERY PROCEDURE USING THE SPIDER FX EMBOLIC PROTECTION DEVICE TO TREAT A CALCIFIED TARGET LESION IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY, THE SPIDER WIRE DETACHED AT THE SNAP POINT WITHIN THE SHEATH. THE SPIDER FILTER WAS NOT OVERFILLED AND THE DEVICE WAS INTACT ON REMOVAL. THE TARGET VESSEL WAS DESCRIBED AS HAVING MODERATE TORTUOSITY AND MODERATE CALCIFICATION. THE DETACHED COMPONENT WAS REMOVED BY SNARING. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY AND NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 25663110 ↗
• MalfunctionFeb 5, 2026Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING TREATMENT OF A SEVERE CALCIFIED LESION IN THE PROXIMAL LEFT SUPERFICIAL FEMORAL ARTERY (PERIPHERAL ARTERY) USING THE EP SPD2-US-060-320 SPIDER FX, A FILTER RECOVERY ISSUE OCCURRED WHEN THE FILTER CAME OFF THE DEVICE AS IT WAS RETRACTED INTO THE CAPTURE CATHETER. THE VESSEL DIAMETER WAS 6MM AND EMBOLIC PROTECTION WAS USED WITH THE SPIDERFX 6.0MM DEVICE. THE VESSEL WAS BOTH PRE-DILATED AND POST-DILATED. THE INSTRUCTIONS FOR USE WERE FOLLOWED WITHOUT ISSUE, AND NO RESISTANCE WAS ENCOUNTERED DURING DEVICE ADVANCEMENT. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT, AND THE PHYSICIAN OBTAINED ACCESS AT A NEW SITE TO COMPLETE THE PROCEDURE. THE DETACHMENT OCCURRED WITHIN THE SHEATH. THE SHEATH WAS REMOVED WITH THE DETACHED PART OF THE SPIDER STILL INTACT WITHIN THE SHEATH. NO OTHER INCIDENT FOLLOWED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24267297 ↗
• MalfunctionDec 9, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THERE WAS A FILTER RECOVERY ISSUE ASSOCIATED WITH THE SPIDER FX EMBOLIC PROTECTION DEVICE DURING A PROCEDURE INVOLVING THE CAROTID ARTERY. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE. THE SPIDER FILTER WAS NOT OVER-FILLED. THE DEVICE WAS INTACT UPON REMOVAL AND WAS SAFELY REMOVED FROM THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23755689 ↗
• InjurySep 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE USING THE SPIDER FX EMBOLIC PROTECTION DEVICE, MODERATE RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE THROUGH A SEVERELY CALCIFIED TARGET LESION WITH 90% STENOSIS AND MODERATE VESSEL TORTUOSITY IN THE PROXIMAL RIGHT SUPERFICIAL FEMORAL ARTERY. THE DEVICE TIP AND BASKET DETACHED WITHIN THE VESSEL. THE DETACHED COMPONENTS WERE SNARED AND REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 22991289 ↗
• InjuryJun 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE A PROTÉGÉ RX AND SPIDER FX WAS USED TO TREAT THE LEFT COMMON ILIAC. POST PROCEDURE PATIENT SUFFERED ACUTE MULTIFOCAL EMBOLIC CEREBROVASCULAR ACCIDENT. PATIENT DEVELOPED LEFT SIDED MOTOR DEFICITS WITH LEFT ARM AND LEFT LEG WEAKNESS. THIS WEAKNESS WAS REVERSED WHEN MEAN ARTERIAL PRESSURE (MAP) WAS GREATER THAN 100. LEVOPHED INITIATED TO MAINTAIN THIS PRESSURE. DEFICITS RETURNED IN THE INTENSIVE CARE UNIT. COMPUTED TOMOGRAPHY ANGIOGRAPHY - HEAD NEGATIVE FOR INTRACEREBRAL HEMORRHAGE. MAGNETIC RESONANCE IMAGING SHOWED MULTIPLE ACUTE INFARCTS INVOLVING BOTH CEREBELLAR AND CEREBRAL HEMISPHERES SUGGESTIVE FOR EMBOLIC ETIOLOGY. CONTINUED DUAL ANTIPLATELET THERAPY. PATIENT RECOVERED.

  Patient problems: Intracranial Hemorrhage; Muscle Weakness/Atrophy; Stroke/CVA

  MAUDE report 22211537 ↗
• InjuryJun 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE A PROTÉGÉ RX AND SPIDER FX WERE USED TO TREAT THE LEFT COMMON ILIAC. DURING PROCEDURE PATIENT SUFFERED HYPERTENSION. PATIENT EXPERIENCED EXTREMELY LABILE BLOOD PRESSURE DURING PROCEDURE WITH SYSTOLIC UP TO 220 MMHG. HYDRAL WAS ADMINISTERED AT END OF PROCEDURE AND SYSTOLIC BLOOD PRESSURE WENT DOWN TO 110 MMHG. PATIENT RECOVERED.

  Patient problems: High Blood Pressure/ Hypertension

  MAUDE report 22179118 ↗
• MalfunctionMar 5, 2025Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT PLAQUE IN THE COMMON CAROTID ARTERY USING THE EP SPD2-US-060-320 SPIDER FX, THERE WAS A MODERATE DEGREE OF TORTUOSITY AND CALCIFICATION IN THE ARTERY. THE VESSEL WAS PRE-DILATED. THERE WAS DIFFICULTY RETRIEVING THE DEVICE FROM THE PATIENT. THE SUPPLIED RECOVERY CATHETER WAS USED. THEN THE RE-CAPTURE SHEATH (BLUE PART), DID NOT ADVANCE THROUGH THE SPIDER WIRE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21525856 ↗
• InjuryDec 11, 2024Entrapment of Device; Difficult to Remove; Entrapment of Device; Difficult to Remove

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A CALCIFIED LESION IN THE RIGHT PROXIMAL MID DISTAL SUPERFICIAL FEMORAL ARTERY WITH 80% STENOSIS AND AN 80MM LESION LENGTH, THERE WERE DEVICE-RELATED ISSUES INVOLVING THE TURBOHAWK PLUS LS AND THE SPIDER FX DEVICES. MINIMAL VESSEL TORTUOSITY AND SEVERE VESSEL CALCIFICATION WERE REPORTED. ARTERY DIAMETER REPORTED AS 7MM. THE PROCEDURE INVOLVED THE USE OF A NON-MEDTRONIC 7F SHEATH, AND PRE- AND POST-DILATION WITH 3MM AND 6MM NANOCROSS DEVICES, RESPECTIVELY. THE PHYSICIAN MADE SEVERAL PASSES WITH TURBOHAWK PLUS. UPON CLEANING AND REINSERTING THE DEVICE INTO THE BODY, THE TURBOHAWK PLUS NOSE BECAME BOUND TO THE SPIDER FX WIRE, MAKING IT EXTREMELY DIFFICULT TO ADVANCE. SEVERE RESISTANCE WAS ENCOUNTERED FOR EACH DEVICE, AND EXCESSIVE FORCE WAS USED DURING THE PROCEDURE. REMOVAL DIFFICULTIES WERE REPORTED. THE PHYSICIAN USED CLAMPS AND A TECHNICIAN'S AID TO FORCEFULLY REMOVE THE HAWK FROM THE SHEATH AND PULL IT OFF THE WIRE. THE DEVICES WERE REMOVED SUCCESSFULLY IN TANDEM WITHOUT INJURY, AND THE PROCEDURE WAS COMPLETED USING NEW MEDTRONIC DEVICES, SPECIFICALLY A TURBOHAWK PLUS LS AND A 6MM SPIDER FX, WITH NO FURTHER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20903202 ↗
• MalfunctionNov 29, 2024Difficult to Remove; Difficult to Remove

  A PHYSICIAN ATTEMPTED TO USE A SPIDER FX EMBOLIC PROTECTION DEVICE/GUIDEWIRE DURING TREATMENT OF THE PATIENT'S POPLITEAL ARTERY TIBIAL/POPLITEAL TRUNK. 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 WAS DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED UNKNOWN STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. 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 THE PATIENT. A REPLACEMENT SPIDER FX DEVICE WAS USED TO COMPLETE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20809312 ↗
• MalfunctionMar 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  LIMITED INFORMATION REPORTS THAT AN ATTEMPT WAS MADE TO USE A SPIDER FX TO TREAT A LESION AND THAT CATHETER DISCONNECTED DURING PROCEDURE. IFU WAS FOLLOWED. PROCEDURE WAS COMPLETED WITH A NEW PRODUCT. NO PATIENT INJURY. WHEN THE DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY FOR EVALUATION, IT WAS NOTED THAT THE CATHETER WAS DETACHED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18835312 ↗
• MalfunctionOct 26, 2023Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  A PHYSICIAN WAS USING A SPIDER FX FOR TREATMENT OF A 40MM CALCIFIED LESION WITH 99% STENOSIS IN THE LEFT COMMON ILIAC ARTERY AND SUPERFICIAL FEMORAL ARTERY. THE ARTERY WAS 7MM IN DIAMETER WITH MODERATE TORTUOSITY AND SEVERE CALCIFICATION. A 7FR NON MEDTRONIC SHEATH AND A SPIDER GUIDEWIRE. THE VESSEL WAS PRE-DILATED. THE IFU WAS FOLLOWED. IT WAS REPORTED THE SPIDER WAS PLACED PRIOR TO USING A HAWKONE LS. WHEN ATTEMPTING TO RETRIEVE THE FILTER WITH THE BLUE END OF THE SPIDER RETRIEVAL CATHETER, THE FILTER COULD NOT BE CAPTURED ENTIRELY, SO A PARTIAL CAPTURE WITH THE MOUTH ENCLOSED IN THE CATHETER WAS ATTEMPTED. ONCE IN SHEATH, THE PHYSICIAN FELT RESISTANCE AND PULLED AND THE WHITE/GREEN PORTION OF THE SPIDER CATHETER BROKE AWAY (LEAVING THE BLUE PORTION ON THE WIRE IN THE BODY). CATHETER SEGMENT WAS STUCK ON THE GUIDEWIRE. THE PHYSICIAN THEN ATTEMPTED TO USE A NON MEDTRONIC GUIDE CATHETER WHICH WAS UNABLE TO RETRIEVE THE SPIDER FILTER. ANOTHER NON MEDTRONIC GUIDE CATHETER 7FR WAS USED AND THIS COULD NOT CAPTURE IT. THE PHYSICIAN PULLED THE SHEATH WITH EVERYTHING INSIDE AS A UNIT OUT OF THE BODY WHILE HOLDING MANUAL PRESSURE. THE PHYSICIAN PLANNED ON USING A DRUG COATED BALLOON BUT WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18009878 ↗
• MalfunctionAug 23, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A SPIDER FX TO TREAT A CALCIFIED LESION IN THE MID COMMON CAROTID ARTERY. DEGREE OF TORTUOSITY WAS MODERATE. DEGREE OF CALCIFICATION WAS  MODERATE. THE VESSEL WAS NOT PRE-DILATED. THE VESSEL WAS NOT POST-DILATED. IFU WAS FOLLOWED. THE SPIDER WIRE BROKE DURING ADVANCEMENT AND THE PROCEDURE COULD NOT CONTINUE. THE PART OUTSIDE THE CATHETER WAS CUT OFF, THE PHYSICIAN REMOVED THE SPIDER AND THEN AND USED A NEW PRODUCT TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17601862 ↗
• InjuryJun 29, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  A PHYSICIAN WAS USING A SPIDER FX FOR TREATMENT OF A 40MM PLAQUE LESION WITH 80% STENOSIS IN THE MID LEFT COMMON ARTERY. THE ARTERY DIAMETER WAS 5MM WITH SEVERE TORTUOSITY AND CALCIFICATION. A 6FR NON MEDTRONIC SHEATH WAS USED. THE VESSEL WAS NOT PRE-DILATED. THEIFU WAS NOT FOLLOWED AS EXTREME FORCE WAS USED TO RETRACT THE SPIDER INTO THE SUPPORT CATHETER. THE FILTER DETACHED FROM WIRE IN THE SHEATH. THE PROCEDURE WAS COMPLETED BY REMOVAL OF THE FILTER VIA CUTDOWN INTO ARTERIOTOMY AND FORCEPS. SITE WAS CLOSED USING MANUAL PRESSURE AND SUTURES.

  Patient problems: Insufficient Information

  MAUDE report 17226433 ↗
• InjuryFeb 27, 2023Entrapment of Device; Detachment of Device or Device Component; Entrapment of Device; Detachment of Device or Device Component

  A SPIDER FX AND HAWKONE DIRECTIONAL ATHERECTOMY DEVICE WERE BEING USED FOR THE TREATMENT OF A 250MM CALCIFIED PLAQUE LESION WITH CHRONIC TOTAL OCCLUSION IN THE MID LEFT SUPERFICIAL FEMORAL ARTERY. THE ARTERY DIAMETER WAS 5MM WITH SEVERE CALCIFICATION. A 7FR NON MEDTRONIC SHEATH WERE USED.. THE LESION WAS PRE-DILATED. THE IFU WAS FOLLOWED. IT WAS REPORTED AFTER ADVANCING A HAWKONE LX, IT APPEARED TIP WAS STUCK TO FILTER MARKER. THE PHYSICIAN WAS ABLE TO GET IT LOOSE. ATTEMPTED FILTER RETRIEVAL WAS UNSUCCESSFUL. FILTER ULTIMATELY BROKE OFF AND HAD TO BE SNARED. NO DEFECTS OF THE ATHERECTOMY DEVICE NOTED, ONLY THE SPIDER FILTER. THE PROCEDURE WAS COMPLETED USING A NEW WIRE, CATHETER, BALLOON ANGIOPLASTY AND A NON MEDTRONIC ATHERECTOMY DEVICE. NO PATIENT INJURY REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 16442373 ↗
• MalfunctionJan 17, 2023Deformation Due to Compressive Stress; Detachment of Device or Device Component; Deformation Due to Compressive Stress; Detachment of Device or Device Component

  A PHYSICIAN WAS ATTEMPTING TO USE A SPIDER FX TO TREAT A LESION IN THE RIGHT CCA. THE IFU WAS FOLLOWED. IT WAS REPORTED THAT A KINK IN THE MIDDLE OF THE CATHETER OCCURRED DURING INITIAL ADVANCEMENT. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY WAS REPORTED. WHEN THE DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY IT WAS NOTED THAT THE CATHETER WAS DETACHED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16182565 ↗
• InjuryOct 24, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  A PHYSICIAN WAS USING A SPIDER FX EMBOLIC PROTECTION DEVICE FOR TREATMENT OF THE POPLITEAL ARTERY. IT WAS REPORTED THAT THE SPIDER F ILTER WAS ADVANCED. THE NON-MDT SUPPORT CATHETER WAS THEN EXCHANGED FOR A 2.4MM NON-MDT ATHERECTOMY CATHETER. ONE PASS WAS MADE IN THE PROXIMAL PART OF THE OCCLUDED SFA. AFTER THE CATHETER WAS PULLED BACK UP, THE FILTER MIGRATED UP AS WELL. ATTEMPTS TO ADVANCE THE FILTER RESULTED IN SEPARATION OF THE PROXIMAL PART OF THE WIRE FROM THE DISTAL PART. THE NON-MDT CATHETER WAS REMOVED, AND THE NON-MDT SUPPORT CATHETER WAS READVANCED INTO THE POPLITEAL ARTERY. A NON-MDT WIRE WAS THEN ADVANCED INTO THE POPLITEAL AFTER NEXT TO THE SPIDER FILTER. THE SUPPORT CATHETER WAS REMOVED, AND THE FILTER WAS THEN RETRIEVED. THE SUPPORT CATHETER WAS READVANCED OVER THE NON-MDT WIRE AND THE WIRE WAS EXCHANGED FOR A NEW FILTER.

  Patient problems: Insufficient Information

  MAUDE report 15657673 ↗
• InjuryOct 17, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  A PHYSICIAN WAS USING A SPIDER FX EMBOLIC PROTECTION DEVICE FOR TREATMENT OF A PROXIMAL CALCIFIED LESION 80MM IN LENGTH AND A DISTAL CALCIFIED LESION 120MM IN LENGTH IN THE SUPERFICIAL FEMORAL ARTERY. THE LESIONS HAD 90-99% STENOSIS AND THE ARTERY HAD SEVERE CALCIFICATION. THE IFU WAS NOT FOLLOWED AS A SPIDER DEVICE CAN NOT BE USED WITH CSI. IT IS REPORTED THE SPIDER TIP DETACHED BEFORE ANY ATTEMPT WAS MADE TO CAPTURE. A SNARE WAS USED TO RETRIEVE THE FILTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15614085 ↗
• MalfunctionSep 29, 2022Device Difficult to Setup or Prepare; Detachment of Device or Device Component; Device Difficult to Setup or Prepare; Detachment of Device or Device Component

  PHYSICIAN WAS ATTEMPTING TO USE A SPIDER FX EMBOLIC PROTECTION/GUIDEWIRE DURING PROCEDURE. THE VESSEL WAS NOT PRE DILATED. IFU WAS FOLLOWED. FILTER LOADING/FILTER ADVANCEMENT ISSUE OCCURRED. THE SUPPLIED RECOVERY CATHETER WAS USED. IT WAS REPORTED THAT PHYSICIAN ATTEMPTED TO DEPLOY THE FILTER AFTER PASSING THROUGH THE LESION, BUT THE FILTER DID NOT EXIT THE CATHETER. A NEW SPIDER FX WAS USED TO COMPLETE PROCEDURE. THERE WAS NO PROBLEM WITH THE PATIENT. NO VESSEL DAMAGE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15508060 ↗
• MalfunctionMar 23, 2022Entrapment of Device; Fracture; Detachment of Device or Device Component; Entrapment of Device; Fracture; Detachment of Device or Device Component

  PHYSICIAN WAS ATTEMPTING TO USE A SPIDER FX GUIDEWIRE DURING PROCEDURE TO TREAT THE GREAT SAPHENOUS VEIN (GSV). THE VESSEL WAS PRE DILATED. IFU WAS FOLLOWED. IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO RETRIEVE SPIDER FX AND THE FILTER BECAME EMBEDDED IN AN EXISTING STENT IN A SAPHENOUS VEIN GRAFT. PHYSICIAN CONTINUED TO ATTEMPT REMOVAL AND WAS ABLE TO REMOVE THE SPIDER WIRE. HOWEVER, THE DISTAL 2CM OF THE SPIDER WIRE FRACTURED AND REMAINS IN THE PATIENT. THE TIP/FILTER DETACHMENT DID NOT RESULT IN INJURY TO THE PATIENT. PHYSICIAN WAS ABLE TO POST DILATE AND FELT THAT THE RESULT WAS SATISFACTORY. PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 13857180 ↗
• MalfunctionJan 5, 2022Use of Device Problem; Deformation Due to Compressive Stress; Difficult to Advance; Use of Device Problem; Deformation Due to Compressive Stress; Difficult to Advance

  PHYSICIAN WAS ATTEMPTING TO USE THE SPIDER FX EMBOLIC PROTECTION DEVICE DURING PROCEDURE TO TREAT MODERATELY CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY(SFA).THE DEVICE HAD EXCEEDED ITS EXPIRY DATE. THE USER WAS AWARE DEVICE WAS PASSED EXPIRY DATE AND USED REGARDLESS. THE VESSEL HAD MODERATE TORTUOSITY AND EXHIBITED 70% STENOSIS. IFU WAS FOLLOWED. IT WAS REPORTED THAT THERE WAS AN INSERTING SHAFT KINK OBSERVED ON INITIAL ADVANCEMENT AND UNABLE TO CROSS. RESISTANCE WAS FELT DURING ADVANCEMENT. THE DEVICE DID ENTER PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER SPIDER DEVICE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13167402 ↗
• InjuryNov 24, 2021Entrapment of Device; Difficult to Remove; Entrapment of Device; Difficult to Remove

  PHYSICIAN WAS ATTEMPTING TO USE THE SPIDER FX EMBOLIC PROTECTION DEVICE DURING PROCEDURE TO TREAT SEVERELY CALCIFIED LESION IN THE MID SUPERFICIAL FEMORAL ARTERY (SFA). IT WAS REPORTED THAT THE SPIDER COULD NOT BE RETRIEVED AFTER STENT PLACEMENT. THE SPIDER GOT CAUGHT ON THE FRESHLY DEPLOYED STENT. THE PATIENT WAS TAKEN TO SURGERY TO REMOVE SPIDER AND STENT. NO FURTHER PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 12867328 ↗
• MalfunctionNov 10, 2021Difficult to Remove; Detachment of Device or Device Component; Device Damaged by Another Device; Physical Resistance/Sticking; Difficult to Remove; Detachment of Device or Device Component; Device Damaged by Another Device; Physical Resistance/Sticking

  PHYSICIAN ATTEMPTED TO USE A SPIDER FX EMBOLIC PROTECTION DEVICE WITH A HAWKONE ATHERECTOMY DEVICE AND NON-MEDTRONIC 7FR SHEATH DURING TREATMENT OF A CALCIFIED LESION IN THE PATIENT'S MID LEFT SUPERFICIAL FEMORAL ARTERY (SFA) OF DIAMETER 7MM. IFU WAS FOLLOWED. IT IS REPORTED THE HAWKONE DEVICE JUMPED WHILE USING IT AND GOT STUCK ON THE SPIDER WIRE. THE HAWKONE WOULD NOT PULL BACK OFF THE SPIDER AND DURING REMOVAL THE SPIDER SEPARATED FROM THE WIRE BUT REMAINED STUCK ON THE DEVICE. EVERYTHING WAS REMOVED FROM THE PATIENT. A NEW SPIDER FX AND HAWKONE WERE USED TO COMPETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12787260 ↗
• InjuryOct 21, 2021Fracture; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Fracture; Deformation Due to Compressive Stress; Detachment of Device or Device Component

  PHYSICIAN WAS ATTEMPTING TO USE A 6MM SPIDER FX GUIDEWIRE AND EMBOLIC PROTECTION ALONG WITH A NON-MEDTRONIC 6FR SHEATH DURING PROCEDURE TO TREAT A MODERATELY CALCIFIED LESION IN THE LEFT MID SUPERFICIAL FEMORAL ARTERY (SFA). THE VESSEL IN LITTLE TORTUOUS. THE VESSEL WAS PRE AND POST DILATED. IFU WAS FOLLOWED. A KINK WAS NOTED 2CM ABOVE THE SPIDER, WITH RESISTANCE FELT DURING WITHDRAWAL. THE DAMAGED COMPONENT WAS NOTED DURING PROCEDURE WITH RESISTANCE FELT DURING WITHDRAWAL. THE DELIVERY CATHETER WAS BROKEN IN 3 SEGMENTS (MULTIPLE SEGMENTS). IT WAS REPORTED THAT UPON RETRIEVAL RESISTANCE WAS FELT, SPIDER BASKET WAS REMOVED BUT ON A SMALL PORTION OF CATHETER. NO CATHETER SEGMENT OR FRAGMENTS WAS STUCK ON THE GUIDEWIRE. ONLY 0.5CM WAS STILL ON SPIDER WIRE, THE REST WAS IN THE ARTERY. A BILATERAL CUTDOWNS WAS DONE TO RETRIEVE CATHETER. NO FURTHER INJURY REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12672194 ↗
• InjuryAug 5, 2021Difficult to Remove; Difficult to Remove

  PHYSICIAN WAS ATTEMPTING TO USE THE HAWKONE DIRECTIONAL ATHERECTOMY ALONG WITH 6FR NON MEDTRONIC SHEATH AND 6MM SPIDER FX EMBOLIC PROTECTION DURING PROCEDURE TO TREAT A LESION IN THE PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY WITH 100% STENOSIS. THERE WAS NO TORTUOSITY IN THE VESSEL. IFU WAS FOLLOWED. THE VESSEL WAS POST DILATED. IT WAS REPORTED THAT THE HAWKONE NOSECONE DETECTED WHILE PULLING THROUGH THE SHEATH. MINIMAL RESISTANCE WAS FELT. THE PROCEDURE WAS COMPLETED BY SNARING OUT THE DETACHED NOSECONE AND REMOVING THE SPIDER WIRE TOGETHER. A NEW HAWKONE AND 7MM SPIDER FX WERE USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12281482 ↗
• InjuryMay 19, 2021Entrapment of Device; Difficult to Remove; Entrapment of Device; Difficult to Remove

  PHYSICIAN WAS ATTEMPTING TO USE HAWKONE DIRECTIONAL ATHERECTOMY AND SPIDER FX GUIDEWIRE DURING PROCEDURE TO TEAT A SEVERELY CALCIFIED LESION IN THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) WITH CHRONIC TOTAL OCCLUSION (CTO-100%). THE VESSEL WAS MODERATELY TORTUOUS. THE VESSEL WAS PRE AND POST DILATED. IT IS UNKNOWN IF IFU WAS FOLLOWED. IT WAS REPORTED THAT THE HAWKONE WAS USED SUCCESSFULLY AND THEN THE DECISION WAS MADE TO USE IT A SECOND TIME. THE TECH WAS REMINDED TO LINE UP THE BLACK LINE ON THE HAWK BEFORE LOADING, HOWEVER PHYSICIAN WAS NOT ABLE TO SEE THE LINE PRIOR TO IT GOING IN TO THE PATIENT. IT APPEARED THE HAWK EITHER HAD SEVERE WIRE WRAP OR WAS NOT LOADED PROPERLY OR BOTH AND TWO LARGE LOOPS FORMED WHEN THE PHYSICIAN WAS TRYING TO PULL THE DEVICE OUT. ACCESS WAS GIVEN UP AND EVERYTHING WAS PULLED BACK INTO THE RIGHT GROIN AND THE PATIENT WAS TAKEN TO THE OR AND THE WIRE AND DEVICE WERE REMOVED SURGICALLY. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11846971 ↗