GLIDEWIRE ADVANTAGE GA3502Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 04987350703644), received between Feb 17, 2017 and Jan 8, 2026 — classified as 17 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Material Separation” (13 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 8, 2026

  FROM STAFF: UPON REMOVING THE 0.035" 260CM GLIDEWIRE ADVANTAGE FROM THE RIGHT GROIN, IT WAS FOUND THAT THE FLOPPY DISTAL END CAME LOOSE FROM THE WIRE (WITHOUT COMING OFF COMPLETELY), EXPOSING THE BARE METAL END. PRODUCT WAS REMOVED FROM FIELD AND GIVEN TO TEAM LEADER. UNSURE OF WHAT COULD HAVE CAUSE THIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24002937 ↗
• InjuryNov 6, 2025Material Frayed; Material Frayed

  TERUMO MEDICAL CORPORATION RECEIVED THE REPORTED INFORMATION. THE GLIDEWIRE ADVANTAGE WAS USED ON THE PATIENT; HOWEVER, THE TIP BECAME FRAYED. THE PROCEDURE PERFORMED WAS AN LLE, AND NO BLOOD LOSS WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23490439 ↗
• InjuryAug 3, 2025Break; Break

  THE USER FACILITY REPORTED THAT THEY HAD A PERIPHERAL CASE WITH AN UP AN OVER TECHNIQUE BY ACCESSING CONTRALATERAL SIDE TO TAKE WIRE UP AND OVER THE CORINA INTO THE OPPOSITE ILIAC. THE WIRE BROKE WHILE ACROSS THE STEEP BIFURCATING COMMON ILIAC. THE WIRE BROKE INTO TWO PIECES. THE PART WHERE THE WIRE BROKE WAS AT THE METAL AREA PROXIMAL TO THE HYDROPHILIC PART OF THE WIRE. THE DISTAL BROKEN PART OF THE WIRE REMAINED IN THE BODY WHEN PULLING THE WIRE BACK FROM CATHETER AND PART OF THE WIRE REMAINED IN THE CATHETER. THE WIRE WAS REMOVED VIA A CUT DOWN OF THE OTHER SIDE COMMON FEMORAL ARTERY (CFA) AND THE CASE WAS COMPLETED THROUGH A CUT DOWN ENDODARCTOMY OF THE COMMON FEMORAL ARTERY (CFA) AND A ENDOVASCULAR REPAIR AND REVASCULARIZATION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) THROUGH THE CUT DOWN OF THE COMMON FEMORAL ARTERY (CFA). THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC.

  Patient problems: Foreign Body In Patient

  MAUDE report 22696657 ↗
• InjuryAug 3, 2025Break; Break

  THE USER FACILITY REPORTED THAT THEY HAD A PERIPHERAL CASE WITH AN UP AN OVER TECHNIQUE BY ACCESSING CONTRALATERAL SIDE TO TAKE WIRE UP AND OVER THE CORINA INTO THE OPPOSITE ILIAC. THE WIRE BROKE WHILE ACROSS THE STEEP BIFURCATING COMMON ILIAC. THE WIRE BROKE INTO TWO PIECES. THE PART WHERE THE WIRE BROKE WAS AT THE METAL AREA PROXIMAL TO THE HYDROPHILIC PART OF THE WIRE. THE DISTAL BROKEN PART OF THE WIRE REMAINED IN THE BODY WHEN PULLING THE WIRE BACK FROM CATHETER AND PART OF THE WIRE REMAINED IN THE CATHETER. THE WIRE WAS REMOVED VIA A CUT DOWN OF THE OTHER SIDE COMMON FEMORAL ARTERY (CFA) AND THE CASE WAS COMPLETED THROUGH A CUT DOWN ENDODARCTOMY OF THE COMMON FEMORAL ARTERY (CFA) AND A ENDOVASCULAR REPAIR AND REVASCULARIZATION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) THROUGH THE CUT DOWN OF THE COMMON FEMORAL ARTERY (CFA). THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC.

  Patient problems: Foreign Body In Patient

  MAUDE report 22696656 ↗
• InjuryMar 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACULTY REPORTED THAT RADIAL TO PERIPHERAL CASES RESULTED IN A SIGNIFICANT AORTIC DISSECTION FROM THE HEART TO THE DISTAL AORTA. IT IS UNCLEAR IF THE GLIDEWIRE ADVANTAGE WAS THE CAUSE OF THE DISSECTION. THE EQUIPMENT USED INCLUDED THE GLIDEWIRE ADVANTAGE, 400 STIFF ANGLE GLIDE, 119CM DESTINATION SLENDER, AND 200CM NAVICROSS. THE DISSECTION WAS NOT NOTICED DURING THE PROCEDURE, BUT THE PATIENT LATER REQUIRED OPEN SURGERY AND EXPERIENCED SHUTDOWN OF THE OPPOSITE LEG. BLOOD LOSS WAS LESS THAN 250CC. THE REPORTED EVENT RESULTED IN PATIENT INJURY AND REQUIRED MEDICAL OR SURGICAL INTERVENTION. SURGERY WAS NECESSARY TO REPAIR THE TOTAL AORTIC DISSECTION AND THE CLOTTED LEFT LEG. THE EVENT OCCURRED POST-OPERATIVELY.

  Patient problems: Vascular Dissection

  MAUDE report 21517276 ↗
• InjuryMar 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACULTY REPORTED THAT RADIAL TO PERIPHERAL CASES RESULTED IN A SIGNIFICANT AORTIC DISSECTION FROM THE HEART TO THE DISTAL AORTA. IT IS UNCLEAR IF THE GLIDEWIRE ADVANTAGE WAS THE CAUSE OF THE DISSECTION. THE EQUIPMENT USED INCLUDED THE GLIDEWIRE ADVANTAGE, 400 STIFF ANGLE GLIDE, 119CM DESTINATION SLENDER, AND 200CM NAVICROSS. THE DISSECTION WAS NOT NOTICED DURING THE PROCEDURE, BUT THE PATIENT LATER REQUIRED OPEN SURGERY AND EXPERIENCED SHUTDOWN OF THE OPPOSITE LEG. BLOOD LOSS WAS LESS THAN 250CC. THE REPORTED EVENT RESULTED IN PATIENT INJURY AND REQUIRED MEDICAL OR SURGICAL INTERVENTION. SURGERY WAS NECESSARY TO REPAIR THE TOTAL AORTIC DISSECTION AND THE CLOTTED LEFT LEG. THE EVENT OCCURRED POST-OPERATIVELY.

  Patient problems: Vascular Dissection

  MAUDE report 21517267 ↗
• InjuryNov 12, 2024Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE WIRE TIP BROKE OFF IN PATIENT WHILE TRYING TO BALLOON. THERE WAS NO BLOOD LOSS. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6)2024: THE PROCEDURE WAS A SPLENIC THROMBECTOMY. THE WIRE TIP WAS REMOVED FROM THE PATIENT. THE PATIENT WAS STABLE AND THERE WAS NO HARM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 20670814 ↗
• InjuryNov 12, 2024Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE WIRE TIP BROKE OFF IN PATIENT WHILE TRYING TO BALLOON. THERE WAS NO BLOOD LOSS. ADDITIONAL INFORMATION WAS RECEIVED ON 18OCT2024: THE PROCEDURE WAS A SPLENIC THROMBECTOMY. THE WIRE TIP WAS REMOVED FROM THE PATIENT. THE PATIENT WAS STABLE AND THERE WAS NO HARM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 20670811 ↗
• MalfunctionJul 25, 2024Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT IT APPEARED THE GLIDE PORTION ATTEMPTED TO SEPARATE FROM THE SOLID STEEL CORE. THE GLIDE ADVANTAGE WAS EXTRACTED WITHOUT HARM AND THERE WAS NO PATIENT INJURY AND/OR REQUIRE MEDICAL OR SURGICAL INTERVENTION. ADDITIONAL INFORMATION WAS RECOVERED ON 02JUL2024: PER THE SURGEON, THE PROCEDURE PERFORMED WHEN THE ISSUE OCCURRED WAS VENOGRAM WITH BILATERAL PERCUTANEOUS THROMBECTOMY. THERE WAS NO TORTUOUS ANATOMY ENCOUNTERED BY THE DEVICE DURING THE USE OF GLIDEWIRE. THE DEVICE STRETCHED OUT OF SHAPE EXPOSING THE TWO (GLIDE PORTION VS. STEEL CORE) AS DESCRIBED. THE WIRE HAD TO BE REMOVED, WIRE ACCESS WAS LOST, AND HAD TO REGAIN ACCESS TO CHRONIC OCCLUSION OF IVC. THE DEVICE WAS PULLED OUT TO REMOVE FROM PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 19827838 ↗
• InjuryApr 4, 2024Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT DURING A CEREBRAL ANGIOGRAM THE TIP OF THE GUIDEWIRE ADVANTAGE BROKE OFF AND WAS INSIDE THE CATHETER. THEN, WAS FLUSHED OUT INTO THE VESSEL. THE WIRE WAS STILL IN THE VESSEL. THERE WAS NO BLOOD LOSS. THE EVENT OCCURRED INTRA-OPERATIVE. ADDITIONAL INFORMATION WAS RECEIVED ON 20 MAR 2024: THERE WAS DIFFICULTY PUSHING THE WIRE INSIDE OF THE CATHETER, TO THE POINT OF IT NOT EASILY ADVANCING, THEN THE WIRE WAS PULLED OUT AND PLACED ON THE BACK SCRUB TABLE. IT WAS MEASURED THAT 4MM OF THE NITINOL TIP WAS BROKEN OFF. THERE WAS NO INTERVENTIONAL PLAN TO GO AND REMOVE THE TIP OFF THE WIRE. THE PATIENT WAS AS STABLE FOR THEIR STATUS AS A POST RUPTURED ANEURYSM. THE PATIENT HAS A HISTORY OF METH USAGE, PATIENT EXPERIENCED A RUPTURED ANEURYSM AND HAD A CRANIOTOMY.

  Patient problems: Foreign Body In Patient

  MAUDE report 19042449 ↗
• InjuryApr 4, 2024Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT DURING A CEREBRAL ANGIOGRAM THE TIP OF THE GUIDEWIRE ADVANTAGE BROKE OFF AND WAS INSIDE THE CATHETER. THEN, WAS FLUSHED OUT INTO THE VESSEL. THE WIRE WAS STILL IN THE VESSEL. THERE WAS NO BLOOD LOSS. THE EVENT OCCURRED INTRA-OPERATIVE. ADDITIONAL INFORMATION WAS RECEIVED ON 20 MAR 2024: THERE WAS DIFFICULTY PUSHING THE WIRE INSIDE OF THE CATHETER, TO THE POINT OF IT NOT EASILY ADVANCING, THEN THE WIRE WAS PULLED OUT AND PLACED ON THE BACK SCRUB TABLE. IT WAS MEASURED THAT 4MM OF THE NITINOL TIP WAS BROKEN OFF. THERE WAS NO INTERVENTIONAL PLAN TO GO AND REMOVE THE TIP OFF THE WIRE. THE PATIENT WAS AS STABLE FOR THEIR STATUS AS A POST RUPTURED ANEURYSM. THE PATIENT HAS A HISTORY OF METH USAGE, PATIENT EXPERIENCED A RUPTURED ANEURYSM AND HAD A CRANIOTOMY.

  Patient problems: Foreign Body In Patient

  MAUDE report 19042210 ↗
• InjuryMar 27, 2024Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE TIP OF THE INVOLVE GLIDEWIRE WIRE BROKE OFF IN THE PATIENT DURING A PROCEDURE. THEY WERE ABLE TO RETRIEVE THE TIP OF THE WIRE WITH A SNARE, AND NOTHING WAS LEFT INSIDE THE PATIENT. THERE WAS NO HARM TO THE PATIENT. THE REPORTED EVENT DID NOT RESULT IN PATIENT INJURY OR REQUIRE SURGICAL INTERVENTION. THERE IS NOT A DIRECT ALLEGATION THAT THE REPORTED DEVICE CAUSED OR CONTRIBUTED TO PATIENT INJURY. THE EVENT OCCURRED INTRA-OPERATIVE. ADDITIONAL INFORMATION WAS RECEIVED ON 07 MAR 2024: THE PROCEDURE PERFORMED WAS A THROMBECTOMY WITH INARI EQUIPMENT. THE PATIENT'S ANATOMY WAS TORTUOUS WHEN WORKING WITH THE WIRE THAT BROKE. THE SIZE OF WIRE TIP THAT BROKE OFF WAS 3 CENTIMETERS (CM). THEY WERE USING AN INARI'S THROMBECTOMY DEVICE WITH THE GUIDEWIRE AT THE TIME OF BREAKAGE.

  Patient problems: Foreign Body In Patient

  MAUDE report 18987234 ↗
• InjuryMar 27, 2024Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE TIP OF THE INVOLVE GLIDEWIRE WIRE BROKE OFF IN THE PATIENT DURING A PROCEDURE. THEY WERE ABLE TO RETRIEVE THE TIP OF THE WIRE WITH A SNARE, AND NOTHING WAS LEFT INSIDE THE PATIENT. THERE WAS NO HARM TO THE PATIENT. THE REPORTED EVENT DID NOT RESULT IN PATIENT INJURY OR REQUIRE SURGICAL INTERVENTION. THERE IS NOT A DIRECT ALLEGATION THAT THE REPORTED DEVICE CAUSED OR CONTRIBUTED TO PATIENT INJURY. THE EVENT OCCURRED INTRA-OPERATIVE. ADDITIONAL INFORMATION WAS RECEIVED ON 07 MAR 2024: THE PROCEDURE PERFORMED WAS A THROMBECTOMY WITH INARI EQUIPMENT. THE PATIENT'S ANATOMY WAS TORTUOUS WHEN WORKING WITH THE WIRE THAT BROKE. THE SIZE OF WIRE TIP THAT BROKE OFF WAS 3 CENTIMETERS (CM). THEY WERE USING AN INARI'S THROMBECTOMY DEVICE WITH THE GUIDEWIRE AT THE TIME OF BREAKAGE.

  Patient problems: Foreign Body In Patient

  MAUDE report 18987106 ↗
• MalfunctionMar 21, 2024Material Deformation; Positioning Problem; Material Deformation; Positioning Problem

  THE USER FACILITY REPORTED THAT THE PHYSICIAN PERFORMED A BELOW THE KNEE PERIPHERAL INTERVENTION (OF THE LEG). AFTER COMPLETING A RUNOFF, THE PHYSICIAN USED A GLIDE ADVANTAGE AND NAVICROSS TO ATTEMPT TO CROSS THE BTK LESION. HE STATED "SOMETHING DID NOT FEEL RIGHT" WHEN REFERRING TO THE GLIDEWIRE ADVANTAGE CROSSING THE LESION. UPON REMOVING THE WIRE, HE NOTICED THAT THE TIP OF THE GLIDEWIRE ADVANTAGE LOOKED DAMAGED. THE PHYSICIAN DID SAY THAT IT MAY HAVE GOTTEN CAUGHT UP ON THE CALCIFIED LESION; HOWEVER, HE HAD NEVER HAD THIS HAPPEN BEFORE. THE ESTIMATED BLOOD WAS LESS THAN 250CC'S. ADDITIONAL INFORMATION WAS RECEIVED ON 27 FEB 2024: THE DOCTOR STATED IT LOOKED LIKE POLYURETHANE BUNCHED UP/PEELED BACK. IT WAS BELIEVED THAT HE WAS ABLE TO PASS ANOTHER WIRE THROUGH WITHOUT ISSUE. THE DOCTOR THOUGHT IT HAD TO DO WITH PUSHING BY THE CHUNK OF CALCIUM IN THE VESSEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18949957 ↗
• MalfunctionOct 13, 2023Break; Break

  THE USER FACILITY REPORTED THAT THE GLIDEWIRE ADVANTAGE WAS IN A NAVICROSS 0.035 150 CM ANGLED CATHETER AND WAS ATTEMPTING TO ACCESS LEFT ILIAC FROM THE RIGHT ILIAC. NAVICROSS WAS BUCKLING AND KINKED AND COULD NOT BE ADVANCED. WIRE WAS UNABLE TO BE TAKEN OUT OR ADVANCED IN THE NAVICROSS SO THE WHOLE SYSTEM WAS REMOVED. THAT IS WHEN THEY NOTICED THE HYDROPHILIC PORTION OF THE GWA HAD DETACHED FROM THE AMPLATZ PORTION. IT WAS NOT NOTED UNTIL LATER THAT THE TIP HAD ALSO BROKEN OFF BUT WAS STUCK IN THE NAVICROSS. THE NAVICROSS WAS FLUSHED AND THE TIP WAS REMOVED ON THE TABLE. NOTHING WAS BROKEN OFF INSIDE THE PATIENT. NO ESTIMATED BLOOD LOSS. PATIENT CONDITION IS NKA. NO PATIENT INJURY AND/OR MEDICAL OR SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2023: THE NAVICROSS WAS BEING USED IN CONJUNCTION WITH THE GLIDEWIRE ADVANTAGE (GWA). ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2023: SAMPLE OF GUIDEWIRE MAIN BODY AND A FRAGMENT WAS RETURNED TO MANUFACTURER. NO EVIDENCE OF A FRACTURE ON THE MAIN BODY. IT WAS THOUGHT THAT THE FRAGMENT RETURNED WAS NOT THE ONE THAT FRACTURED. REPORTING ASSOCIATE STATED THAT THERE WAS A SECOND PIECE OF WIRE INSIDE THE BAG TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17936518 ↗
• MalfunctionSep 16, 2023Stretched; Detachment of Device or Device Component; Stretched; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT THE INVOLVED DEVICE WIRE WAS FEELING STRANGE DURING THE PROCEDURE, THEREFORE THE WIRE WAS REMOVED. THE WIRE HAD A COATING ON THE END PORTION OF THE WIRE. THAT PORTION OF THE WIRE HAD DETACHED ITSELF FROM THE WIRE BODY. THE PROCEDURE BEING PERFORMED WAS A LEG INTERVENTION. ESTIMATED BLOOD LOSS WAS LESS THAN 250 CC. THE EVENT OCCURRED INTRA-OPERATIVE. THE PATIENT WAS NOT INJURED, MEDICAL OR SURGICAL INTERVENTION WAS NOT REQUIRED. THERE IS NOT A DIRECT ALLEGATION THAT THE REPORTED DEVICE CAUSED OR CONTRIBUTED TO PATIENT INJURY AND/OR NEED FOR MEDICAL INTERVENTION. ADDITIONAL INFORMATION WAS RECEIVED ON 23 AUG 2023: NOTHING WAS LEFT IN PATIENT. PHOTO WAS PROVIDED OF THE ITEM AND PACKAGE WAS PROVIDED WITH THE PPR THAT HAS THE LOT# ON IT. NO TESTING WAS PERFORMED TO CONFIRM THE TIP OF THE BROKEN WIRE WAS REMOVED FROM THE PATIENT BECAUSE THE WIRE WAS STRETCHED OUT, NOT BROKEN. ADDITIONAL INFORMATION WAS RECEIVED ON 24 AUG 2023: THE CUSTOMER PULLED THE WIRE OUT OF THE PATIENT IN ITS ENTIRETY. ALL IN ONE PIECE. ADDITIONAL INFORMATION WAS RECEIVED ON 25 AUG 2023: PRODUCT WAS A GUIDEWIRE. NOT INFECTIOUS AND NO ANTI-CANCER AGENTS. THE GUIDEWIRE WAS PLACED WITH A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17762181 ↗
• MalfunctionApr 7, 2023Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE USER FACILITY REPORTED THAT THE DOCTOR WAS PERFORMING AN AORTIC AND PERIPHERAL ANGIOGRAM AND AFTER GOING UP AND OVER AORTIC BIFURCATION WHERE BARE METAL ILIAC STENTS WERE PRESENT, BILATERALLY USING A VESICOCUTANEOUS FISTULAS (VCF) CATHETER AND GLIDEWIRE ADVANTAGE THE DOCTOR REMOVED THE WIRE AND PERFORMED A RIGHT LEG RUNOFF. WHEN ATTEMPTING TO RE-INSERT THE WIRE THROUGH THE CATHETER TO ADVANCE THE CATHETER FURTHER, RESISTANCE WAS FELT. THE DOCTOR PULLED BACK ON THE WIRE AND FELT A "RELEASE". THE CATHETER WAS REMOVED, AND IT NOTED WAS THAT IT WOULD NOT FLUSH ON THE BACK TABLE AND THAT IT HAD MULTIPLE AREAS OF DAMAGE FROM THE ILIAC STENTS. THE DOCTOR CUT THE CATHETER AND FOUND THAT THE END OF THE WIRE HAD BROKEN OFF IN THE CATHETER. THE END OF THE WIRE WAS PULLED OUT AND KEPT FOR SAMPLE. THE PHYSICIAN USED FLUOROSCOPY TO CONFIRM NO PIECES OF WIRE WERE LEFT IN THE BODY. NO PIECES OF WIRE WERE PRESENT, AND A NEW WIRE AND CATHETER WERE USED TO COMPLETE CASE WITHOUT ISSUE. THERE WAS NO BLOOD LOSS. THERE WAS NOT A DIRECT ALLEGATION THAT THE REPORTED DEVICE CAUSED OR CONTRIBUTED TO PATIENT INJURY AND/OR NEED FOR MEDICAL INTERVENTION. ADDITIONAL INFORMATION WAS RECEIVED ON 23 MAR 2023: A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16702241 ↗
• MalfunctionJan 23, 2023Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THE GLIDEWIRE ADVANTAGE WIRE INVOLVED WAS SNARED FOR FLOSSING DURING A BRACHIAL TO PERIPHERAL CASE. THE GLIDEWIRE INVOLVED BECAME DEFORMED. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PROCEDURE WAS A SUCCESS. THE BLOOD LOSS WAS LESS THAN 250CC'S. THE EVENT OCCURRED INTRA-OPERATIVE. ADDITIONAL INFORMATION WAS RECEIVED ON 27 DEC 2022: IT WAS REPORTED THAT THE SNARING OF THE WIRE CAUSED THE EVENT. ANOTHER .018" ADVANTAGE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16227351 ↗
• MalfunctionMay 25, 2022Unraveled Material; Unraveled Material

  THE USER FACILITY REPORTED THAT THE WIRE INVOLVED WAS UNRAVELED WHEN THE PACKAGE WAS OPENED. A DIFFERENT WIRE WAS USED. THE PATIENT WAS FINE. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE EVENT OCCURRED PRE-TREATMENT. THE PROCEDURE OUTCOME WAS SUCCESSFUL. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THERE WAS NO EQUIPMENT OR OTHER DEVICES USED WITH THE ABOVE PRODUCT. ADDITIONAL INFORMATION WAS RECEIVED ON 09 MAY 2022: THE PROCEDURE PERFORMED WAS A LEG ANGIO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14496550 ↗
• MalfunctionJul 28, 2021Material Separation; Material Separation

  DURING A RIGHT LEG THROMBECTOMY PROCEDURE IT WAS REPORTED THAT THE TIP OF THE GLIDEWIRE ADVANTAGE BROKE OFF IN THE PENUMBRA CAT 6 CATHETER. THE CAT 6 CATHETER BECAME STUCK IN THE ARTERY AND THE PATIENT HAD TO HAVE SURGERY TO HAVE IT REMOVED. A CUT DOWN WAS PREFORMED TO REMOVE PENUMBRA CATHETER. THE PATIENT WAS STABLE. THE PROCEDURE WAS COMPLETED. ADDITIONAL INFORMATION WAS RECEIVED ON 02JUL2021. PER THE CATHETER REP WHO IS IN THE PROCEDURE AT THE TIME, AND HE DID NOT THINK THE WIRE MALFUNCTIONED AT ALL, HE THOUGHT WHEN THEY WERE TAKING THE CATHETER OUT THE PHYSICIAN, WHEN CUTTING THE CATHETER OUT, CUT THE TIP THE WIRE. ADDITIONAL INFORMATION WAS RECEIVED ON 06JUL2021. THE PATIENT'S CONDITION WAS REPORTED TO BE FINE, AND NO PART WAS LEFT IN THE PATENT'S BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12238185 ↗
• MalfunctionMar 31, 2021Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT RADIFOCUS GLIDEWIRE ADVANTAGE WAS USED DURING THE RIGHT ILIAC TOTAL OCCLUSION WITH RIGHT COMMON FEMORAL ACCESS PROCEDURE. WHEN THE WIRE WAS BEING REMOVED FROM THE AORTA THROUGH THE SHEATH IN COMMON FEMORAL, THE WIRE HAD RESISTANCE THROUGH THE CONCENTRIC CALCIFIED LESION. AS A RESULT, THE HYDROPHILIC COATING PEELED BACK OFF THE GLIDEWIRE PORTION AS WIRE WAS BEING REMOVED FROM BODY. THE COATING DID REMAIN ATTACHED TO THE WIRE AND NO COATING WAS LEFT IN THE BODY; ALL WAS REMOVED. THE PATIENT'S CONDITION WAS STABLE, AND THE PROCEDURE OUTCOME WAS SUCCESSFUL. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11594854 ↗
• InjuryMar 9, 2020Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THE INVOLVED RADIFOCUS GLIDEWIRE ADVANTAGE WAS DAMAGED. IT WAS A RIGHT LOWER EXTREMITY VENOUS CASE. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. THE PATIENT WAS IN STABLE CONDITION AND THE PROCEDURE OUTCOME WAS SUCCESSFUL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9806021 ↗
• InjuryMar 9, 2020Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THE INVOLVED RADIFOCUS GLIDEWIRE ADVANTAGE WAS DAMAGED. IT WAS A RIGHT LOWER EXTREMITY VENOUS CASE. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. THE PATIENT WAS IN STABLE CONDITION AND THE PROCEDURE OUTCOME WAS SUCCESSFUL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9806020 ↗
• MalfunctionJan 30, 2020Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE INVOLVED RADIFOCUS GLIDEWIRE ADVANTAGE WAS USED. AFTER INITIAL ANGIO WAS TAKEN WITHOUT THE WIRE IN THE GUIDE, THE MD INSERTED THE GWA BACK INTO THE COPILOT TO ADVANCED DOWN THE SUPERFICIAL FEMORAL ARTERY (SFA). IT WAS NOTICED THAT THE WIRE WAS NOT ADVANCING SMOOTHLY, AND THE MD PULLED THE GWA OUT AND NOTICED THE GLIDE COATING HAD BEEN SEPARATED. THE WIRE WAS PLACED TO THE SIDE. A VERSACORE WIRE WAS USED THE REST OF THE CASE. NO HARM WAS NOTED TO THE PATIENT; THE PATIENT'S CONDITION WAS STABLE. THE PROCEDURE WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED ON 14JAN2020. THE PROCEDURE FOR THE PATIENT WAS AN ANGIOGRAPHY AND INTERVENTION FOR SFA. THE WIRE COATING SEPARATED; HOWEVER, DID NOT BREAK OFF. THE COATING WAS STILL ATTACHED TO THE WIRE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9646376 ↗
• InjuryNov 22, 2019Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE PHYSICIAN FROM THE OR ASKED IF THE GLIDEWIRES COULD POTENTIALLY SHEER OFF AND CAUSE A VISUAL CURLY CUE IN A PATIENT. THE PHYSICIAN STATED SHE WAS USING A TERUMO GLIDEWIRE OVER A YEAR AGO AND ACCESSING THE SUBCLAVIAN FOR A PACEMAKER. SHE SUSPECTS THAT SHE SHEARED OFF PART OF THE GLIDEWIRE THROUGH THE LONG NEEDLE IN THE PATIENT AND COULD SEE IT UNDER FLUOROSCOPY UPON REEXAMINATION. ADDITIONAL INFORMATION WAS RECEIVED ON 01NOV2019. THE PHYSICIAN STATED THEY DID A PACEMAKER OVER ONE YEAR AGO AND NOTICED WHAT LOOKED LIKE A CURLY BIT ON A CXR AFTERWARDS. IT ALMOST LOOKED LIKE A FIGURE OF AN 8 SUTURE WITH A KNOT ON THE CXR, ONLY ABOUT 1.5 CM LONG. IT LOOKS LIKE THE POSITION WHERE SHE SOMETIMES PUTS A HEMOSTATIC STITCH TO CINCH A BIT OF PECTORALIS MUSCLE AROUND WHERE THE LEAD EXITS THE PECTORALIS MUSCLE TO MEET THE GENERATOR IN THE PACEMAKER POCKET. SHE ASKED AROUND AND THE OR SUPERVISING NURSE DID NOT KNOW OF A RADIOOPAQUE SUTURE THEY USE IN THE OR. THE SUTURE SHE USUALLY USES FOR THIS HEMOSTATIC STITCH IS VICRYL WHICH USUALLY DOES NOT SHOW UP ON A CXR. THREE MONTHS AGO, THE PATIENT WAS TAKEN TO SURGERY FOR A LEAD REVISION BY ANOTHER SURGEON WHO SAW THI

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9362937 ↗