BAREWIRE 22440-31Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 08717648137808), received between Apr 9, 2019 and Jun 8, 2026 — classified as 21 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Material Separation” (22 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 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 8, 2026

  CARDIOLOGIST PERFORMING A PERIPHERAL ANGIOGRAM, INTRAVASCULAR LITHOTRIPSY/STENT. A BAREWIRE FILTER DELIVERY WIRE WAS BEING USED ON THIS HEAVILY CALICIFIED LEFT LEG. BAREWIRE FRACTURED WITH DISTAL TIP RETENTION IN THE POPLITEAL ARTERY. SUCCESSFUL SNARING OF RETAINED WIRE. MANUFACTURER RESPONSE FOR TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE, BAREWIRE (PER SITE REPORTER). NO RESPONSE. MADE REP [REDACTED] AWARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25425775 ↗
• InjuryApr 16, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT SUPERIOR FEMORAL ARTERY (SFA). AFTER THE LESION WAS DECALCIFIED USING LASER ATHERECTOMY, A BAREWIRE WORKHORSE 315 (BW) WAS USED TO DEPLOY THE FILTRATION ELEMENT IN THE PROCEDURE WITH NO ISSUES NOTED. HOWEVER, WHEN THE BW WAS REMOVED FROM THE PATIENT (WITHOUT RESISTANCE) A POST-ANGIOGRAM SHOWED THAT THE TIP OF THE BW HAD SHEARED OFF AND REMAINED IN THE PATIENT. THEREFORE, A SNARE DEVICE WAS USED TO REMOVE THE TIP FROM THE PATIENT ANATOMY. THERE WAS NO ADVERSE PATIENT SEQUELA NOR CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21848763 ↗
• MalfunctionMar 31, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO A 95% STENOSED LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY WITH HEAVY CALCIFICATION. THE 315CM BAREWIRE WAS LOADED ONTO THE LARGE EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM (EPS) AND ADVANCED TO THE INTENDED LOCATION. A NON-ABBOTT ATHERECTOMY DEVICE WAS THEN ADVANCED ON THE BAREWIRE AND USED IN THE PROCEDURE; HOWEVER, THE ATHERECTOMY DEVICE WAS NOTED TO HAVE LOW STREAM. THEREFORE, THE PHYSICIAN ATTEMPTED TO REMOVE THE ATHERECTOMY DEVICE FROM THE BAREWIRE; HOWEVER, DURING REMOVAL THE ATHERECTOMY DEVICE CONTINUE TO TORQUE CAUSING THE BAREWIRE TO SEPARATE. THE ATHERECTOMY DEVICE AND THE PROXIMAL BAREWIRE WERE REMOVED AS A SINGLE UNIT. ENOUGH OF THE BAREWIRE THAT REMAINED IN THE PATIENT WAS EXPOSED TO ADVANCE THE RETRIEVAL CATHETER AND REMOVED THE EPS FILTER WITHOUT ISSUE. UNSPECIFIED BALLOON DILATATION AND UNSPECIFIED STENT IMPLANTATION WERE USED TO CONTINUE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21732265 ↗
• InjuryMar 6, 2025Entrapment of Device; Material Separation; Entrapment of Device; Material Separation

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A TOTALLY OCCLUDED PREVIOUSLY STENTED LESION IN THE DISTAL LEFT SUPERFICIAL FEMORAL ARTERY (SFA). THE BAREWIRE GUIDE WIRE WAS ADVANCED TO THE TARGET LESION AND A CROSSING CATHETER WAS ADVANCED HOWEVER COULD NOT PASS THROUGH THE OCCLUDED STENTS. THE BAREWIRE WAS PULLED BACK HOWEVER IT BECAME HUNG UP ON THE STENT STRUTS OF ONE OF THE IMPLANTED STENTS AND THE TIP SEPARATED. ANOTHER STENT WAS IMPLANTED TRAPPING THE SEPARATED PORTION OF THE BAREWIRE AND COMPLETING THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21536021 ↗
• MalfunctionMar 5, 2025Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED IN THE RIGHT INTERNAL CAROTID ARTERY WITH MILD CALCIFICATION. THE BAREWIRE WORKHORSE 315 WAS USED WITH THE EMBOSHIELD NAV 6 EMBOLIC PROTECTION SYSTEM(EPS) AS A LONGER GUIDE WIRE WAS NEEDED FOR THE PROCEDURE. THE BAREWIRE AND EPS WERE ADVANCED TO THEIR INTENDED LOCATION AND THEN A NON-ABBOTT BALLOON WAS ADVANCED WITH SLIGHT RESISTANCE WITH THE BAREWIRE AND EVENTUALLY GOT STUCK. AN ATTEMPT WAS MADE TO REMOVE THE BALLOON FROM THE BAREWIRE, BUT SIGNIFICANT RESISTANCE WAS NOTED. THEREFORE, THE BAREWIRE, FILTER AND BALLOON WERE ALL REMOVED AS A SINGLE UNIT. ANOTHER EMBOSHIELD NAV 6 WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21529848 ↗
• MalfunctionFeb 18, 2025Break; Break

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). THE NAV6 EMBOLIC PROTECTION SYSTEM (EPS) WAS ADVANCED TO THE TARGET LESION WITHOUT ISSUE. DURING REMOVAL OF THE EPS IT WAS NOTED THE DISTAL TIP OF THE BAREWIRE UNRAVELED BUT REMAINED IN ONE PIECE. THE EPS WAS REMOVED WITHOUT ANY ISSUES. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21395511 ↗
• InjuryDec 30, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE 315 CM BAREWIRE WAS USED WITH AN EMBOSHIELD NAV 6 DEVICE. THE EMBOSHIELD WAS USED SUCCESSFULLY IN THE PROCEDURE WITHOUT ISSUE; HOWEVER, AFTER REMOVAL THE TIP AND COIL OF THE BAREWIRE WERE NOTED TO HAVE SEPARATED IN THE PATIENT. THEREFORE, A SNARE WAS USED TO REMOVE THE SEPARATED TIP AND COIL. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21037309 ↗
• MalfunctionNov 18, 2024Material Separation; Material Separation

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT COMMON FEMORAL ARTERY. DURING INSERTION OF THE BAREWIRE INTO THE ANATOMY THE GUIDE WIRE SEPARATED. THE SEPARATED PORTION OF THE GUIDE WIRE WAS ABLE TO BE RETRIEVED BACK INTO THE NAV6 CATHETER AND REMOVED FROM THE PATIENT. THE PROCEDURE WAS CONTINUED WITH ANOTHER NAV6 DEVICE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20712252 ↗
• MalfunctionSep 3, 2024Material Separation; Stretched; Material Separation; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT DISTAL POPLITEAL ARTERY. THE BAREWIRE (BW) WAS ADVANCED THROUGH THE VESSEL WITHOUT ANY RESISTANCE; HOWEVER IT APPEARED THE TIP HAD SEPARATED. THE NAV6 EMBOLIC PROTECTION SYSTEM WAS THEN REMOVED AND IT WAS NOTED THE TIP COILS OF THE BW HAD STRETCHED. THE BW WAS NOTED TO SEPARATE OUTSIDE THE ANATOMY AFTER THE DEVICE WAS COMPLETELY REMOVED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. SUBSEQUENT TO FILING THE INITIAL REPORT, UPDATE TO EVENT DETAILS: AFTER THE NAV6 EMBOLIC PROTECTION SYSTEM WAS REMOVED, THE PROCEDURE WAS COMPLETED WITH BALLOONING. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20125712 ↗
• InjuryAug 28, 2024Material Separation; Failure to Advance; Material Separation; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH HEAVY CALCIFICATION. THE BAREWIRE WORKHORSE 315 GUIDE WIRE WAS ADVANCED WITH RESISTANCE DUE TO THE ANATOMY AND THE TIP OF THE GUIDE WIRE SEPARATED IN THE COMMON FEMORAL ARTERY. A SNARE DEVICE WAS USED TO REMOVE THE SEPARATED TIP. ANOTHER UNSPECIFIED GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20089370 ↗
• InjuryAug 21, 2024Material Separation; Failure to Advance; Material Separation; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN IN-STENT RESTENOSIS IN THE RIGHT SUPERIOR FEMORAL ARTERY. A BAREWIRE FROM THE EMBOSHIELD NAV6 WAS ATTEMPTED TO BE ADVANCED; HOWEVER, MET RESISTANCE WITH THE PREVIOUSLY IMPLANTED STENT. THE STEP GOT CAUGHT ON THE STENT STRUT AND TIP OF THE BAREWIRE BECAME DETACHED. THE SEPARATED TIP WAS ATTEMPTED TO BE SNARED OUT; HOWEVER, IT WAS UNSUCCESSFUL AND THE TIP REMAINED IN THE STRUT STENT. A NON-ABBOTT GUIDE CATHETER WAS ABLE TO BE ADVANCED AND ANOTHER UNSPECIFIED WIRE WAS ATTEMPTED TO SNARE OUT THE TIP, BUT ALSO FAILED. A BALLOON WAS USED TO FURTHER EMBED THE SEPARATED TIP. THE PROCEDURE WAS ABORTED AND RESTENOSIS LEFT UNTREATED. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 20011677 ↗
• InjuryAug 20, 2024Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE RIGHT COMMON ILIAC ARTERY (CIA). AFTER THE LEFT COMMON FEMORAL ARTERY WAS PUNCTURED, THE BAREWIRE GUIDE WIRE WAS ADVANCED HOWEVER THE AORTOILIAC BIFURCATION WAS TOO STEEP THEREFORE IT WAS DIFFICULT TO ADVANCE THE WIRE. THE NAV6 EMBOLIC PROTECTION SYSTEM (EPS) DELIVERY CATHETER WAS ADVANCED OVER THE BAREWIRE HOWEVER RESISTANCE WAS MET. AFTER ATTEMPTING TO ADVANCE FOR 5-10 MINUTES, A KINK WAS NOTED TO THE DELIVERY CATHETER. THE DELIVERY CATHETER ALONG WITH THE BAREWIRE WAS RETRACTED WITH RESISTANCE. ONCE OUTSIDE THE ANATOMY IT WAS NOTED THE DELIVERY CATHETER AND THE BAREWIRE HAD SEPARATED AND A PORTION REMAINED IN THE BODY. A SNARE DEVICE WAS USED TO REMOVE THE SEPARATED PORTION. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20007913 ↗
• InjuryJul 25, 2024

  DURING A LOWER EXTREMITY ANGIOGRAM/ANGIOPLASTY, THE EMBOSHIELD NAV6 RADIOPAQUE WIRE TIP BECAME LODGED IN THE VESSEL. WIRE TIP BECAME DETACHED AND WAS SITTING IN THE DISTAL TIBIAL ARTERY. MULTIPLE ATTEMPTS WERE MADE TO SNARE AND RETRIEVE THE WIRE TIP UNSUCCESSFULLY. WIRE TIP WAS UNINTENTIONALLY RETAINED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19839672 ↗
• InjuryJul 24, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE POPLITEAL AND TIBIAL ARTERY. THE FIRST BAREWIRE WORKSHORSE SHEARD OFF WHEN EXCHANGING THROUGH A 4FR CATHETER. THE SECOND BAREWIRE WORKHORSE SHEARD OFF IN A .018 GUIDE CATHETER. BOTH BAREWIRE WORKHORSE GUIDE WIRES SHEARD OFF AT THE OLIVE DURING THE WIRE EXCHANGE. THE SEPARATED PORTIONS WERE REMOVED VIA SNARE. THERE WAS ADVERSE PATIENT SEQUELA; CLINICALLY SIGNIFICANT DELAY WAS NOTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19818783 ↗
• InjuryJul 24, 2024Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE POPLITEAL AND TIBIAL ARTERY. THE FIRST BAREWIRE WORKSHORSE SHEARD OFF WHEN EXCHANGING THROUGH A 4FR CATHETER. THE SECOND BAREWIRE WORKHORSE SHEARD OFF IN A .018 GUIDE CATHETER. BOTH BAREWIRE WORKHORSE GUIDE WIRES SHEARD OFF AT THE OLIVE DURING THE WIRE EXCHANGE. THE SEPARATED PORTIONS WERE REMOVED VIA SNARE. THERE WAS ADVERSE PATIENT SEQUELA; CLINICALLY SIGNIFICANT DELAY WAS NOTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19818660 ↗
• InjuryJul 1, 2024Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). DURING THE PROCEDURE, THE EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM (EPS) WAS USED AND WAS RETRIEVED WITHOUT ISSUE. THE BAREWIRE WAS LEFT IN PLACE AND A 5FR GUIDE CATHETER (GC) WAS ADVANCED OVER THE BAREWIRE. WHEN THE BAREWIRE WAS PULLED RESISTANCE WAS FELT WITH THE GC AND THE COIL ON THE BAREWIRE SEPARATED IN THE SFA. THE SEPARATED TIP WAS SNARED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19643785 ↗
• InjuryJun 21, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT IN STENT RESTENOSIS IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE 315CM WAS EXCHANGED ONTO AN EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM (EPS) AND USED IN THE PROCEDURE WITH A ROTATIONAL ATHERECTOMY DEVICE IN THE PROCEDURE. AFTER, ROTABLATION THE TIP OF THE BAREWIRE WAS NOTED TO BECOME SEPARATED; THEREFORE, THE A SNARE WAS USED TO REMOVE THE PROXIMAL PART OF THE WIRE AND THE FILTER. THEN, THE SNARE WAS USED AGAIN TO REMOVE THE TIP OF THE WIRE. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19580616 ↗
• MalfunctionMay 6, 2024Break; Break

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE HEAVILY CALCIFIED SUPERFICIAL FEMORAL ARTERY. WHEN THE BAREWIRE WAS REMOVED FROM THE PACKAGE, IT WAS NOTED THE TIP COILS WERE STRETCHED [UNRAVELED] THEREFORE THE WIRE WAS NOT USED. A SECOND BAREWIRE WAS ADVANCED WITH THE EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM (EPS) TO THE PERONEAL ARTERY, THE FILTER WAS DEPLOYED IN THE POPLITEAL ARTERY, AND THEN A JETSTREAM DEVICE WAS USED. AFTER THE FILTER WAS RETRIEVED AND THE EPS REMOVED FROM THE PATIENT, IT WAS NOTED THE TIP COILS OF THE BAREWIRE WERE UNRAVELED AND VERY STRETCHED OUT. THE PHYSICIAN PULLED ON THE TIP OF THE WIRE AND IT SEPARATED FROM THE BODY OF THE WIRE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19254529 ↗
• MalfunctionMay 6, 2024Break; Break

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE HEAVILY CALCIFIED SUPERFICIAL FEMORAL ARTERY. WHEN THE BAREWIRE WAS REMOVED FROM THE PACKAGE, IT WAS NOTED THE TIP COILS WERE STRETCHED [UNRAVELED] THEREFORE THE WIRE WAS NOT USED. A SECOND BAREWIRE WAS ADVANCED WITH THE EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM (EPS) TO THE PERONEAL ARTERY, THE FILTER WAS DEPLOYED IN THE POPLITEAL ARTERY, AND THEN A JETSTREAM DEVICE WAS USED. AFTER THE FILTER WAS RETRIEVED AND THE EPS REMOVED FROM THE PATIENT, IT WAS NOTED THE TIP COILS OF THE BAREWIRE WERE UNRAVELED AND VERY STRETCHED OUT. THE PHYSICIAN PULLED ON THE TIP OF THE WIRE AND IT SEPARATED FROM THE BODY OF THE WIRE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19254303 ↗
• InjuryMar 29, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE NAV6 FILTER WAS PLACED IN THE POPLITEAL ARTERY WITHOUT ISSUE USING THE BAREWIRE. A NON-ABBOTT 4.0X60 INTRAVASCULAR LITHOTRIPSY BALLOON WAS ADVANCED OVER THE BAREWIRE AND BALLOON DILATATION WAS PERFORMED AT THE SUPERFICIAL FEMORAL ARTERY. AN ATTEMPT WAS MADE TO PULL THE IVL BALLOON OFF THE BAREWIRE; HOWEVER IT WAS STUCK ON THE WIRE. AS THE IVL WAS STUCK ON THE WIRE, A RETRIEVAL CATHETER WAS UNABLE TO BE USED TO RETRIEVE THE FILTER; THEREFORE THE ENTIRE SYSTEM HAD TO BE REMOVED ALL TOGETHER (BAREWIRE, IVL, NAV6). A DRUG COATED BALLOON WAS ADVANCED OVER A DIFFERENT GUIDE WIRE TO FURTHER TREAT THE VESSEL. A FINAL ANGIOGRAM WAS TAKEN AND A DISTAL EMBOLISM WAS NOTED IN THE FOOT. THE PROCEDURE WAS PROLONGED AS TPA MEDICATION WAS INTRAVASCULARLY INJECTED TO TREAT THE EMBOLISM. IN THE PHYSICIANS OPINION, THE NAV6 DID NOT CAUSE THE EMBOLISM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Embolism/Embolus

  MAUDE report 19004106 ↗
• MalfunctionJan 12, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH MODERATE CALCIFICATION. THE EMBOSHIELD NAV 6 WAS POSITIONED IN THE POPLITEAL ARTERY AND USED TOGETHER WITH THE ATHERECTOMY DEVICE. UPON RETRIEVAL OF THE FILTER WITHOUT RESISTANCE, THE PHYSICIAN NOTICED THAT THE TIP OF THE WIRE HAD DETACHED AND WAS CAUGHT IN THE DIAPHRAGM OF THE SHEATH THINKING IT WAS HAIR BECAUSE THE WIRE HAD ALREADY BEEN REMOVED. THE PHYSICIAN PULLED IT OUT OF THE DIAPHRAGM OF THE SHEATH WITH HIS GLOVED HAND/FINGERTIPS AND REALIZED THAT IT WAS THE TIP OF THE WIRE. THE SHEATH STAYED IN THE ANATOMY. FLUOROSCOPY WAS PERFORMED TO CONFIRM NOTHING WAS LEFT IN THE ANATOMY. IT WAS ALSO STATED THAT THE PATIENT HAD A STENT IN THE PROXIMAL SFA THAT WAS PLACED 9 MONTHS PRIOR TO THE PROCEDURE. THE PHYSICIAN BENT THE PROXIMAL END OF THE STENT INWARD ON ITSELF WITH THE LONG UP AND OVER SHEATH PRIOR TO THE INTERVENTION/ ATHERECTOMY/ BALLOONING/ STENTING. THIS INVAGINATED STENT COULD HAVE DAMAGED THE TIP OF THE BAREWIRE. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18504191 ↗
• MalfunctionNov 1, 2023Difficult to Remove; Deformation Due to Compressive Stress; Difficult to Advance; Difficult to Remove; Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH 95% STENOSIS, MILD CALCIFICATION AND MILD TORTUOSITY. THE 315 BAREWIRE WORKHORSE GUIDEWIRE AND THE ATHERECTOMY DEVICE GOT STUCK WITH EACH OTHER, MAKING IT DIFFICULT TO WITHDRAW THE ATHERECTOMY DEVICE. AFTER VARIOUS ATTEMPTS TO SUCCESSFULLY WITHDRAW THE ATHERECTOMY DEVICE, IT WAS REMOVED INDEPENDENTLY. HOWEVER, WHEN PREPARING TO RETRIEVE THE EMBOSHIELD NAV6 FILTER FROM THE POPLITEAL ARTERY, THE RETRIEVAL CATHETER COULD NOT BE DELIVERED. IT WAS NOTED THAT THE BAREWIRE PORTION THAT WAS OUTSIDE THE ANATOMY WAS BENT. SO THE PHYSICIAN USED THE 5F SINGLE-BEND CATHETER TO RETRIEVE THE FILTER. THERE WAS NO ADVERSE PATIENT SEQUELAE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18048779 ↗
• MalfunctionSep 8, 2023Break; Difficult to Remove; Stretched; Difficult to Advance; Break; Difficult to Remove; Stretched; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT SUPERFICIAL FEMORAL (SFA) ARTERY WITH MODERATE CALCIFICATION, MILD TORTUOSITY AND 100% STENOSIS. THE EMBOSHIELD EMBOLIC PROTECTION SYSTEM (EPS) BAREWIRE WAS BEING ADVANCED DISTAL TO THE LESION PRIOR TO FILTER DELIVERY AND THERE WAS RESISTANCE WITH THE NON-ABBOTT GUIDING CATHETER. THE BAREWIRE WAS THEN REMOVED INDEPENDENTLY FROM THE NON-ABBOTT GUIDING CATHETER. HOWEVER, WHEN THE DEVICE WAS REMOVED IT WAS NOTED THAT THE BAREWIRE WAS CAUGHT ON THE NON-ABBOTT GUIDING CATHETER. THE COILS WERE NOTED TO BE UNRAVELED. NOTHING WAS LEFT IN THE PATIENT AND THERE WERE NO ADVERSE PATIENT EFFECTS. A NEW GUIDING CATHETER AND A NEW BAREWIRE WERE USED TO COMPLETE THE PROCEDURE WITHOUT ISSUE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17712275 ↗
• MalfunctionAug 30, 2023Off-Label Use; Material Separation; Off-Label Use; Material Separation

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH IN-STENT STENOSIS AND A CHRONIC TOTAL OCCLUSION (CTO). THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT COMMON FEMORAL ARTERY WITH HEAVY CALCIFICATION. THE VESSEL WAS PRE-DILATED WITH A BALLOON. THE BAREWIRE WAS EXTERNALIZED OUT OF A RIGHT PEDAL SHEATH. THE BAREWIRE WAS INTRODUCED WITHOUT RESISTANCE THROUGH OUT THE ANTEGRADE ACCESS SHEATH IN THE RIGHT COMMON FEMORAL OPEN/ HYBRID CASE. BOTH SHEATHS WERE IN THE RIGHT LOWER EXTREMITY. HEMOSTATS WERE CLAMPED ON THE DISTAL END OF THE EXTERNALIZED BAREWIRE (WITH THE STEP). UPON ATTEMPTED RETRIEVAL OF THE FILTER, THE HEMOSTATS WERE REMOVED. THE HEMOSTATS WERE UNCLAMPED, HOWEVER, THE DISTAL PORTION OF THE WIRE DETACHED AND FELL ONTO THE STERILE DRAPE WHICH WAS OUTSIDE THE PATIENT. THE PORTION OF THE WIRE THAT FELL OFF INCLUDED THE STEP. THEREFORE, THE FILTER HAD TO BE ASPIRATED WITH THE ASPIRATION CATHETER AND THEN SNARED THE FILTER (FROM ABOVE) IN THE DISTAL POPLITEAL ARTERY TO REMOVE IT FROM THE LEG. THERE WAS NO ADVERSE PATIENT SEQUELAE. NO MEDICATION WAS GIVEN DUE TO THE FILTER BEING SNARED. ALTHOUGH THERE WAS REPORT OF A DELAY, IT WAS CONFIRMED THAT THERE WAS NO ADVERSE PATIENT EFFECT, T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17656071 ↗
• InjuryDec 1, 2022Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MILDLY CALCIFIED DISTAL RIGHT PERONEAL ARTERY. THE BAREWIRE GUIDE WIRE WAS USED WITH A FILTER AND NO DIFFICULTIES WERE NOTED. THE BAREWIRE THEN RECROSSED TO THE TARGET LESION AND A NON-ABBOTT EXCHANGE CATHETER WAS ADVANCED. THE BAREWIRE WAS THEN RETRIEVED; HOWEVER, THERE WAS INTERACTION WITH THE NON-ABBOTT DEVICE AND THE TIP OF THE BAREWIRE SEPARATED. A SNARE DEVICE WAS USED TO RETRIEVE THE SEPARATED TIP WITHOUT ANY PATIENT EFFECT. THERE WAS NO ADVERSE PATIENT EFFECT OR CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15894934 ↗