GLIDEWIRE ADVANTAGE GA1830Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 04987350714763), received between Aug 3, 2020 and Mar 2, 2026 — classified as 14 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Material Separation” (5 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryMar 2, 2026Break

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: WHILE THE WIRE WAS BEING USED IN THE PROCEDURE, THE TIP OF THE WIRE BROKE ROUGHLY 10CM FROM THE DISTAL TIP. THE PHYSICIAN SAID THAT HE WAS IN A HEAVILY CALCIFIED VESSEL AND WAS TORQUING THE WIRE BEFORE IT BROKE. A NEW WIRE WAS OPENED AND THE CASE WAS COMPLETED. NO PATIENT IMPACT WAS REPORTED. THERE WAS NO BLOOD LOSS. ADDITIONAL INFORMATION WAS RECEIVED ON 09FEB2026: THERE WAS A FRAGMENT LEFT IN THE PATIENT'S BODY. THE FRAGMENTS WERE LEFT IN THE VESSEL AS THE PATIENT WILL NEED BYPASS AND THE ARTERY THE TIP BROKE OFF IN IS COMPLETELY OCCLUDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24491724 ↗
• InjuryMar 2, 2026Break

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: WHILE THE WIRE WAS BEING USED IN THE PROCEDURE, THE TIP OF THE WIRE BROKE ROUGHLY 10CM FROM THE DISTAL TIP. THE PHYSICIAN SAID THAT HE WAS IN A HEAVILY CALCIFIED VESSEL AND WAS TORQUING THE WIRE BEFORE IT BROKE. A NEW WIRE WAS OPENED AND THE CASE WAS COMPLETED. NO PATIENT IMPACT WAS REPORTED. THERE WAS NO BLOOD LOSS. ADDITIONAL INFORMATION WAS RECEIVED ON 09FEB2026: THERE WAS A FRAGMENT LEFT IN THE PATIENT'S BODY. THE FRAGMENTS WERE LEFT IN THE VESSEL AS THE PATIENT WILL NEED BYPASS AND THE ARTERY THE TIP BROKE OFF IN IS COMPLETELY OCCLUDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24491722 ↗
• InjuryOct 27, 2025Break; Break

  TERUMO MEDICAL RECEIVED AN FDA MEDWATCH REPORT # MW5175307. THE EVENT DESCRIPTION STATES: "GUIDE WIRE USED IN INTERVENTIONAL RADIOLOGY CASE IS SUSPECTED TO HAVE LEFT A WIRE FRAGMENT BEHIND IN PATIENT RESULTING IN RETAINED FOREIGN OBJECT. THERE ARE MULTIPLE GUIDE WIRES USED AND IT IS IMPOSSIBLE TO KNOW WHICH ONE IT WAS. THE SAME THING HAPPENED TO THE SAME PATIENT ON A DIFFERENT INTERVENTIONAL RADIOLOGY CASE ON (B)(6). WIRE FRAGMENTS WERE NOT REMOVED BECAUSE IT IS NOT IN THE BEST INTEREST OF THE PATIENT TO REMOVE AT THIS TIME, WE PULLED THE LOTS OF WIRES INVOLVED IN CASE IT IS NEEDED AND TO MAKE SURE NO PATIENTS RECEIVED WIRES FROM THOSE LOTS."

  Patient problems: Foreign Body In Patient

  MAUDE report 23398615 ↗
• InjuryOct 27, 2025Break; Break

  TERUMO MEDICAL RECEIVED AN FDA MEDWATCH REPORT # (B)(4). THE EVENT DESCRIPTION STATES: "GUIDE WIRE USED IN INTERVENTIONAL RADIOLOGY CASE IS SUSPECTED TO HAVE LEFT A WIRE FRAGMENT BEHIND IN PATIENT RESULTING IN RETAINED FOREIGN OBJECT. THERE ARE MULTIPLE GUIDE WIRES USED AND IT IS IMPOSSIBLE TO KNOW WHICH ONE IT WAS. THE SAME THING HAPPENED TO THE SAME PATIENT ON A DIFFERENT INTERVENTIONAL RADIOLOGY CASE ON (B)(6). WIRE FRAGMENTS WERE NOT REMOVED BECAUSE IT IS NOT IN THE BEST INTEREST OF THE PATIENT TO REMOVE AT THIS TIME, WE PULLED THE LOTS OF WIRES INVOLVED IN CASE IT IS NEEDED AND TO MAKE SURE NO PATIENTS RECEIVED WIRES FROM THOSE LOTS."

  Patient problems: Foreign Body In Patient

  MAUDE report 23398613 ↗
• InjurySep 9, 2025Peeled/Delaminated; Material Deformation; Peeled/Delaminated; Material Deformation

  THE USER FACILITY REPORTED THAT THE PROCEDURE WAS A PERIPHERAL INTERVENTION ON THE ANTERIOR TIBIAL VESSEL OF THE LEFT LEG VIA RIGHT GROIN ACCESS. A 6 FRENCH DESTINATION SHEATH WAS ADVANCED UP AND OVER THE ILIAC BIFURCATION. THE 018 GWA WAS ADVANCED ACROSS TWO HEAVILY CALCIFIED LESIONS. AN 018 NAVICROSS WAS ADVANCED OVER THE WIRE WITH INTENTION OF WIRE EXCHANGE FOR THE VIPER WIRE. WHEN THE PHYSICIAN PULLED BACK ON THE WIRE, THERE WAS MUCH RESISTANCE. THEY WERE UNABLE TO CAPTURE THE WIRE IN THE NAVICROSS. NAVICROSS WAS REMOVED LEAVING WIRE IN THE ANTERIOR TIBIAL VESSEL. THE PHYSICIAN CARRIED ON WITH THE PROCEDURE AND THE PROCEDURE WAS A SUCCESS. AT THE END, THE PHYSICIAN WAS ABLE TO SAFELY REMOVE THE WIRE. ON REMOVAL, THE WIRE APPEARED TO HAVE BEEN STRIPPED OF THE PLASTIC JACKET TOWARD THE DISTAL END OF THE WIRE. ALL PARTS OF THE PLASTIC JACKET WERE INTACT. THEY ARE CRIMPED UP AT THE TIP AND NITINOL INTERNAL WIRE EXPOSED. THE PHYSICIANS' ASSESSMENT WAS THAT THE WIRE WAS PINNED AND STRIPPED BETWEEN TWO CHUNKS OF CALCIUM. THERE WAS NO BLOOD LOSS. ADDITIONAL INFORMATION WAS RECEIVED ON 25JUL2025: THE PATIENT WAS STABLE, AND THE CASE WAS A COMPLETE SUCCESS. THE WIRE WAS UNABLE TO TRACK T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23006656 ↗
• InjuryAug 7, 2025Peeled/Delaminated; Material Deformation; Peeled/Delaminated; Material Deformation

  THE USER FACILITY REPORTED THAT THE PROCEDURE WAS A PERIPHERAL INTERVENTION ON THE ANTERIOR TIBIAL VESSEL OF THE LEFT LEG VIA RIGHT GROIN ACCESS. A 6 FRENCH DESTINATION SHEATH WAS ADVANCED UP AND OVER THE ILIAC BIFURCATION. THE 018 GWA WAS ADVANCED ACROSS TWO HEAVILY CALCIFIED LESIONS. AN 018 NAVICROSS WAS ADVANCED OVER THE WIRE WITH INTENTION OF WIRE EXCHANGE FOR THE VIPER WIRE. WHEN THE PHYSICIAN PULLED BACK ON THE WIRE, THERE WAS MUCH RESISTANCE. THEY WERE UNABLE TO CAPTURE THE WIRE IN THE NAVICROSS. NAVICROSS WAS REMOVED LEAVING WIRE IN THE ANTERIOR TIBIAL VESSEL. THE PHYSICIAN CARRIED ON WITH THE PROCEDURE AND THE PROCEDURE WAS A SUCCESS. AT THE END, THE PHYSICIAN WAS ABLE TO SAFELY REMOVE THE WIRE. ON REMOVAL, THE WIRE APPEARED TO HAVE BEEN STRIPPED OF THE PLASTIC JACKET TOWARD THE DISTAL END OF THE WIRE. ALL PARTS OF THE PLASTIC JACKET WERE INTACT. THEY ARE CRIMPED UP AT THE TIP AND NITINOL INTERNAL WIRE EXPOSED. THE PHYSICIANS' ASSESSMENT WAS THAT THE WIRE WAS PINNED AND STRIPPED BETWEEN TWO CHUNKS OF CALCIUM. THERE WAS NO BLOOD LOSS. ADDITIONAL INFORMATION WAS RECEIVED ON 25JUL2025: THE PATIENT WAS STABLE, AND THE CASE WAS A COMPLETE SUCCESS. THE WIRE WAS UNABLE TO TRACK T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22737690 ↗
• MalfunctionApr 24, 2025Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THE WIRE BEGAN TO UNRAVEL NEAR THE TIP DURING THE PROCEDURE. NO ATTEMPTS WERE MADE TO SHAPE THE WIRE. THE PATIENT WAS STABLE. THERE WAS NO BLOOD LOSS AND NO PATIENT INJURY AND/OR MEDICAL OR SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED 03APR2025: THE TERUMO TERRITORY MANAGER LOOKED AT THE DEVICE AND HE DID NOT SEE ANY DAMAGE TO THE TIP OF THE WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21906176 ↗
• InjuryMar 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TERUMO MEDICAL RECEIVED A LETTER FROM ABBOTT, ABBOTT PER-2024-0167633, IN REGARD TO AN ADVERSE EVENT. THE DESCRIPTION STATES: "THE REPORT WAS CONCERNING THE .018" X 300 CM GLIDEWIRE ADVANTAGE MANUFACTURED BY TERUMO. IT WAS REPORTED THAT A CARDIOMEMS IMPLANT PROCEDURE WAS ABANDONED DUE TO HEMOPTYSIS. DURING A CARDIOMEMS IMPLANT PROCEDURE, THE CARDIOMEMS DELIVERY CATHETER WAS ADVANCED OVER AN 0.018" X 300 CM GLIDEWIRE ADVANTAGE. BEFORE THE DELIVERY CATHETER ENTERED THE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT), THE PATIENT BEGAN TO COUGH AND WAS FOUND TO HAVE BLOOD IN THEIR MOUTH. THE PROCEDURE WAS THEN ABANDONED DUE TO HEMOPTYSIS. THE ABBOTT REP CONFIRMED THAT NO INTERVENTIONS WERE NEEDED TO STOP THE HEMOPTYSIS AND FLUOROSCOPY DURING THE PROCEDURE WAS PERFORMED TO IDENTIFY POTENTIAL CAUSES. THE PHYSICIAN FELT THAT THE CAUSE OF THE HEMOPTYSIS WAS DAMAGE TO THE DISTAL PULMONARY ARTERY CAUSED BY THE GLIDEWIRE ADVANTAGE. THE PATIENT WAS ADMITTED TO THE INTENSE CARE UNIT (ICU). AFTER THE PROCEDURE FOR MONITORING AND RELEASED ON (B)(6) 2024. THE PROCEDURE PERFROMED WAS CARDIOMEMS IMPLANT.

  Patient problems: Hemoptysis

  MAUDE report 21537811 ↗
• InjuryMar 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TERUMO MEDICAL RECEIVED A LETTER FROM ABBOTT, ABBOTT PER-2024-0167633, IN REGARD TO AN ADVERSE EVENT. THE DESCRIPTION STATES: "THE REPORT WAS CONCERNING THE .018" X 300 CM GLIDEWIRE ADVANTAGE MANUFACTURED BY TERUMO. IT WAS REPORTED THAT A CARDIOMEMS IMPLANT PROCEDURE WAS ABANDONED DUE TO HEMOPTYSIS. DURING A CARDIOMEMS IMPLANT PROCEDURE, THE CARDIOMEMS DELIVERY CATHETER WAS ADVANCED OVER AN 0.018" X 300 CM GLIDEWIRE ADVANTAGE. BEFORE THE DELIVERY CATHETER ENTERED THE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT), THE PATIENT BEGAN TO COUGH AND WAS FOUND TO HAVE BLOOD IN THEIR MOUTH. THE PROCEDURE WAS THEN ABANDONED DUE TO HEMOPTYSIS. THE ABBOTT REP CONFIRMED THAT NO INTERVENTIONS WERE NEEDED TO STOP THE HEMOPTYSIS AND FLUOROSCOPY DURING THE PROCEDURE WAS PERFORMED TO IDENTIFY POTENTIAL CAUSES. THE PHYSICIAN FELT THAT THE CAUSE OF THE HEMOPTYSIS WAS DAMAGE TO THE DISTAL PULMONARY ARTERY CAUSED BY THE GLIDEWIRE ADVANTAGE. THE PATIENT WAS ADMITTED TO THE INTENSE CARE UNIT (ICU). AFTER THE PROCEDURE FOR MONITORING AND RELEASED ON (B)(6) 2024. THE PROCEDURE PERFORMED WAS CARDIOMEMS IMPLANT. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED.

  Patient problems: Hemoptysis

  MAUDE report 21537808 ↗
• InjuryFeb 22, 2023Material Separation; Material Separation

  TERUMO MEDICAL RECEIVED A USER FACILITY MEDWATCH REPORT # (B)(4). THE EVENT DESCRIPTION STATES: "A SMALL PART OF A GUIDEWIRE BROKE OFF INSIDE THE PATIENT'S LEG. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? : ULTRASOUND-GUIDED ACCESS OF THE RIGHT COMMON FEMORAL ARTERY, LARGEST SHEATH 6 FR. 2. INTRODUCTION OF CATHETER INTO AORTA 3. LEFT PELVIC ANGIOGRAM WITH RADIOLOGIC SUPERVISION AND INTERPRETATION 4. LEFT LOWER EXTREMITY ANGIOGRAM WITH RADIOLOGIC SUPERVISION AND INTERPRETATION 5. LEFT DORSALIS PEDIS ACCESS UNDER ULTRASOUND GUIDANCE, 4 FR 6. SELECTIVE CATHETERIZATION OF SUPERFICIAL FEMORAL ARTERY AND POPLITEAL ARTERY WITH BALLOON ANGIOPLASTY (3.0, 4.0 AND 5.0 SERRANATOR BALLOON, AND STENTING (5MM X 120MM + 5MM X 120MM + 5MM X 40MM, + 5MM X 60MM EVERFLEX PROTEGE BM FROM DISTAL COMMON FEMORAL ARTERY TO ABOVE KNEE POPLITEAL ARTERY) 7. SELECTIVE CATHETERIZATION OF LEFT PROFUNDA FEMORIS WITH BALLOON ANGIOPLASTY (5MM X 7. LEFT EXTERNAL ILIAC ARTERY BALLOON ANGIOPLASTY (5MM X 40MM ARMADA BALLOON) 8. RIGHT COMMON FEMORAL ARTERY CLOSURE WITH ANGIOSEAL CLOSURE DEVICE." ADDITIONAL INFORMATION WAS RECEIVED ON 03 FEB 2023: WHEN THE HANDLES ON THE CLIP APPLIERS WERE SQUEEZED THE CLIP APPLIER JAMMED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16418883 ↗
• InjuryFeb 22, 2023Material Separation; Material Separation

  TERUMO MEDICAL RECEIVED A USER FACILITY (B)(4). THE EVENT DESCRIPTION STATES: "A SMALL PART OF A GUIDEWIRE BROKE OFF INSIDE THE PATIENT'S LEG. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? : ULTRASOUND-GUIDED ACCESS OF THE RIGHT COMMON FEMORAL ARTERY, LARGEST SHEATH 6 FR. 2. INTRODUCTION OF CATHETER INTO AORTA 3. LEFT PELVIC ANGIOGRAM WITH RADIOLOGIC SUPERVISION AND INTERPRETATION 4. LEFT LOWER EXTREMITY ANGIOGRAM WITH RADIOLOGIC SUPERVISION AND INTERPRETATION 5. LEFT DORSALIS PEDIS ACCESS UNDER ULTRASOUND GUIDANCE, 4 FR 6. SELECTIVE CATHETERIZATION OF SUPERFICIAL FEMORAL ARTERY AND POPLITEAL ARTERY WITH BALLOON ANGIOPLASTY (3.0, 4.0 AND 5.0 SERRANATOR BALLOON, AND STENTING (5MM X 120MM + 5MM X 120MM + 5MM X 40MM, + 5MM X 60MM EVERFLEX PROTEGE BM FROM DISTAL COMMON FEMORAL ARTERY TO ABOVE KNEE POPLITEAL ARTERY) 7. SELECTIVE CATHETERIZATION OF LEFT PROFUNDA FEMORIS WITH BALLOON ANGIOPLASTY (5MM X 7. LEFT EXTERNAL ILIAC ARTERY BALLOON ANGIOPLASTY (5MM X 40MM ARMADA BALLOON) 8. RIGHT COMMON FEMORAL ARTERY CLOSURE WITH ANGIOSEAL CLOSURE DEVICE." ADDITIONAL INFORMATION WAS RECEIVED ON 03 FEB 2023: WHEN THE HANDLES ON THE CLIP APPLIERS WERE SQUEEZED THE CLIP APPLIER JAMMED. A CLIP DID NOT FE

  Patient problems: Foreign Body In Patient

  MAUDE report 16418876 ↗
• MalfunctionSep 8, 2022Peeled/Delaminated; Peeled/Delaminated

  DURING THE SAMPLE INVESTIGATION PROCESS, IT WAS DISCOVERED THAT THE OUTER LAYER OF THE GLIDEWIRE ADVANTAGE (WHICH WAS USED IN COMBINATION WITH A PROGREAT DEVICE) HAD BEEN PEELED OFF. ON (B)(6) 2022 IT WAS REPORTED FROM A USER FACILITY THAT THE DURING A LEFT INTERNAL ILIAC ARTERY EMBOLIZATION PROCEDURE. A PROGREAT COAXIAL 2.8FR X 130CM WAS ADVANCED THROUGH 4FR X 100CM ANGLED GLIDECATH. DUE TO TORTUOSITY AND COMPLEX ANATOMY ACCESS TOOK A WHILE. COAXIAL GLIDEWIRE GT WAS SWITCHED OUT FOR AN .018" X 300CM GLIDE WIRE ADVANTAGE FOR SUPPORT. PHYSICIAN NOTED THAT THE 2.8FR PROGREAT WAS FEELING TIGHT AND WAS GETTING STUCK IN THE GLIDECATH. THE 2.8FR PROGREAT WAS SWITCHED OUT FOR A 2.4FR X 130CM PROGREAT. THE CATHETER WAS FLUSHED, PREPPED AND A GWA WIRE WAS WIPED. HOWEVER, THE PROGREAT GOT STUCK ON THE WIRE. THE PROGREAT WAS THEN REMOVED, WIRE WIPED AND PROGREAT FLUSHED. HOWEVER, AGAIN THE 2.4FR PROGREAT WAS STUCK. THIS TIME SIGNIFICANT FORCE WAS REQUIRED TO REMOVE THE PROGREAT. DURING THE TIME THE PROGREAT SEPARATED AT DISTAL SECTION OF MICROCATHETER WHERE THE COLOR CHANGES TO GREY. WIRE ACCESS WAS LOST AND A NEW GWA .018" X 300CM WIRE WAS OPENED AND USED. THE PROCEDURE CONTINUED BUT HAD TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15386354 ↗
• MalfunctionFeb 23, 2022Unraveled Material; Difficult to Advance; Unraveled Material; Difficult to Advance

  THE USER FACILITY REPORTED THAT THE VASCULAR SURGEON PERFORMED A CHRONIC TOTAL OCCLUSIONS (CTO) ON AN ANTERIOR TIBIAL CASE AND USED AN .018 GLIDEWIRE ADVANTAGE DUE TO THE PATIENT'S TORTUOUS ANATOMY. THE WIRE WAS NOT TRACKING WELL SO THE DOCTOR REMOVED THE WIRE TO TRY AND FLOAT AN .014 WIRE IN. WHEN REMOVING THE WIRE, THE DOCTOR LOOKED AT THE TIP OF THE WIRE AND SAW THAT IT WAS UNRAVELING. NOTHING WAS LEFT INSIDE OF THE PATIENT'S BODY AND THE PATIENT HAD NO COMPLICATIONS. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE WAS SUCCESSFUL UPON THE USE OF OTHER PRODUCTS. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 17 FEB 2022: THE DOCTOR USED AN 0.014 WIRE TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13585754 ↗
• MalfunctionAug 5, 2021Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE COATING OF THE RADIFOCUS GLIDEWIRE ADVANTAGE WIRE PEELED OFF DURING THE PERIPHERAL CASE. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. THE PATIENT'S CONDITION WAS STABLE. THE PROCEDURE OUTCOME WAS A SUCCESS. ADDITIONAL INFORMATION WAS RECEIVED ON 23JUL2021. THE PROCEDURE WAS COMPLETED USING THE WIRE. THEY DID LASER OVER THE WIRE. A LASER BALLOON WAS USED WITH THE WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12281620 ↗
• InjuryFeb 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT THE RADIFOCUS GLIDEWIRE ADVANTAGE WAS USED DURING THE PROCEDURE. FOLLOWING A SUCCESSFUL SENSOR IMPLANT, THE PATIENT HAD HEMOPTYSIS AND SOME DISCOMFORT. ON NOVEMBER 13TH, THE PATIENT STILL HAD NOT BEEN DISCHARGED FROM THE HOSPITAL DUE TO PERSISTENT HEMOPTYSIS. THE PATIENT RECOVERED AND WAS DISCHARGED. THE PHYSICIAN BELIEVES THAT EITHER THE NON-ABBOTT GUIDEWIRE OR THE DELIVERY CATHETER MAY HAVE PERFORATED A SMALL PART OF THE PULMONARY ANATOMY. THE PATIENT'S CONDITION WAS STABLE. ADDITIONAL INFORMATION WAS RECEIVED ON 01FEB2021. THE PROCEDURE WAS TO PLACE A CARDIOMEMS SENSOR IN ONE OF THE PULMONARY ARTERIES. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2021. THE DOCTOR ALLEGED THAT THE TERUMO GWA PRODUCT - GA1830, COULD HAVE CONTRIBUTED TO ISSUE THE PATIENT DEVELOPED. THE PHYSICIAN WAS NOT CERTAIN IF THE WIRE CAUSED THE PERFORATION OR IF IT WAS THE DELIVERY SYSTEM OF THE CARDIOMEMS DEVICE. THE DOCTOR WAS NOT READY TO BLAME THIS ON THE WIRE. THE PATIENT EVENT DATE REGARDING THE SENSOR IMPLANT WAS (B)(6) 2020 AND THE PATIENT REMAINED HOSPITALIZED ON (B)(6) 2020, PER THE REPORT. THE PATIENT HAD TWO BRONCHOSCOPIES PERFORMED TO REMOVE CLOT FROM THE AIRWAY D

  Patient problems: Discomfort; Great Vessel Perforation; Hemoptysis

  MAUDE report 11292459 ↗
• InjuryFeb 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT THE RADIFOCUS GLIDEWIRE ADVANTAGE WAS USED DURING THE PROCEDURE. FOLLOWING A SUCCESSFUL SENSOR IMPLANT, THE PATIENT HAD HEMOPTYSIS AND SOME DISCOMFORT. ON (B)(6), THE PATIENT STILL HAD NOT BEEN DISCHARGED FROM THE HOSPITAL DUE TO PERSISTENT HEMOPTYSIS. THE PATIENT RECOVERED AND WAS DISCHARGED. THE PHYSICIAN BELIEVES THAT EITHER THE NON-ABBOTT GUIDEWIRE OR THE DELIVERY CATHETER MAY HAVE PERFORATED A SMALL PART OF THE PULMONARY ANATOMY. THE PATIENT'S CONDITION WAS STABLE. ADDITIONAL INFORMATION WAS RECEIVED ON 01FEB2021. THE PROCEDURE WAS TO PLACE A CARDIOMEMS SENSOR IN ONE OF THE PULMONARY ARTERIES. ADDITIONAL INFORMATION WAS RECEIVED ON 03FEB2021. THE DOCTOR ALLEGED THAT THE TERUMO GWA PRODUCT - GA1830, COULD HAVE CONTRIBUTED TO ISSUE THE PATIENT DEVELOPED. THE PHYSICIAN WAS NOT CERTAIN IF THE WIRE CAUSED THE PERFORATION OR IF IT WAS THE DELIVERY SYSTEM OF THE CARDIOMEMS DEVICE. THE DOCTOR WAS NOT READY TO BLAME THIS ON THE WIRE. THE PATIENT EVENT DATE REGARDING THE SENSOR IMPLANT WAS (B)(6) 2020 AND THE PATIENT REMAINED HOSPITALIZED ON (B)(6) 2020, PER THE REPORT. THE PATIENT HAD TWO BRONCHOSCOPIES PERFORMED TO REMOVE CLOT FROM THE AIRWAY DURING THE

  Patient problems: Discomfort; Great Vessel Perforation; Hemoptysis

  MAUDE report 11292456 ↗
• MalfunctionOct 19, 2020Peeled/Delaminated; Peeled/Delaminated

  THE USER FACILITY REPORTED THAT THE INVOLVED 300CM .018 RADI-FOCUS GLIDEWIRE ADVANTAGE DEVICE'S HYDROPHILIC COATING WAS PUSHED BACK EXPOSING THE CORE OF THE WIRE. THE WIRE NEVER ENTERED THE PATIENT'S BODY. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 01OCT2020. IT WAS FOUND POST FLUSH OF THE WIRE BY THE PHYSICIAN PRIOR TO INSERTING INTO CATHETER. THEY OPENED ANOTHER WIRE OF THE SAME TYPE TO COMPLETE THE PROCEDURE. THE PATIENT'S CONDITION WAS UNAFFECTED, AS THE WIRE NEVER ENTERED THEIR BODY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10696366 ↗
• InjuryAug 3, 2020Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE INVOLVED RADIFOCUS GLIDEWIRE ADVANTAGE WAS USED DURING THE PROCEDURE. THE DOCTOR WAS UTILIZING THE INVOLVED WIRE FROM THE RADIAL APPROACH AND CROSSING A RIGHT OSTIAL ILIAC LESION. THE WIRE CROSSED THE LESION AND A 4MM X 40MM ARMADA BALLOON WAS ADVANCED OVER THE WIRE. HOWEVER, THE BALLOON DID NOT CROSS THE LESION. THE PHYSICIAN DECIDED TO GAIN ACCESS IN THE RIGHT GROIN WITH A 7F 23CM BRIGHT TIP CORDIS SHEATH AND UTILIZE A SNARE TO GRAB THE WIRE AND PULL THROUGH THE SHEATH AND OUT AS TO CREATE A RAIL TO ADVANCE THE BALLOON OVER. WHILE SNARING THE WIRE, THE PHYSICIAN PULLED HARD AND QUICKLY, AND ADVANCED THE SHEATH AT THE SAME TIME. THIS WHIPPED THE WIRE INTO THE 7FR SHEATH AND SUBSEQUENTLY CAUSED THE BALLOON TO SHOOT THROUGH THE LESION AND INTO THE SHEATH AS WELL. THE BALLOON WAS ACROSS THE LESION THE DOCTOR STILL COULD NOT INFLATE, DUE TO IT BEING IN THE DISTAL END OF THE SHEATH. HE RETRACTED THE BALLOON BACK OUT OF THE SHEATH; HOWEVER, INADVERTENTLY PULLED THE WIRE BACK PROXIMAL TO THE LESION WITH THE BALLOON. HE THEN STARTED TO CROSS THE OSTIAL ILIAC LESION ONCE AGAIN AND AS SOON AS HE CROSSED THE LESION THE SECOND TIME, HE NOTICED LOSS OF CONTR

  Patient problems: Blood Loss; Device Embedded In Tissue or Plaque

  MAUDE report 10356080 ↗
• InjuryAug 3, 2020Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE INVOLVED RADIFOCUS GLIDEWIRE ADVANTAGE WAS USED DURING THE PROCEDURE. THE DOCTOR WAS UTILIZING THE INVOLVED WIRE FROM THE RADIAL APPROACH AND CROSSING A RIGHT OSTIAL ILIAC LESION. THE WIRE CROSSED THE LESION AND A 4MM X 40MM ARMADA BALLOON WAS ADVANCED OVER THE WIRE. HOWEVER, THE BALLOON DID NOT CROSS THE LESION. THE PHYSICIAN DECIDED TO GAIN ACCESS IN THE RIGHT GROIN WITH A 7F 23CM BRIGHT TIP CORDIS SHEATH AND UTILIZE A SNARE TO GRAB THE WIRE AND PULL THROUGH THE SHEATH AND OUT AS TO CREATE A RAIL TO ADVANCE THE BALLOON OVER. WHILE SNARING THE WIRE, THE PHYSICIAN PULLED HARD AND QUICKLY, AND ADVANCED THE SHEATH AT THE SAME TIME. THIS WHIPPED THE WIRE INTO THE 7FR SHEATH AND SUBSEQUENTLY CAUSED THE BALLOON TO SHOOT THROUGH THE LESION AND INTO THE SHEATH AS WELL. THE BALLOON WAS ACROSS THE LESION THE DOCTOR STILL COULD NOT INFLATE, DUE TO IT BEING IN THE DISTAL END OF THE SHEATH. HE RETRACTED THE BALLOON BACK OUT OF THE SHEATH; HOWEVER, INADVERTENTLY PULLED THE WIRE BACK PROXIMAL TO THE LESION WITH THE BALLOON. HE THEN STARTED TO CROSS THE OSTIAL ILIAC LESION ONCE AGAIN AND AS SOON AS HE CROSSED THE LESION THE SECOND TIME, HE NOTICED LOSS OF CONTR

  Patient problems: Blood Loss; Device Embedded In Tissue or Plaque

  MAUDE report 10356077 ↗