GLIDEWIRE GS3509Recalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 04987350773654), received between May 23, 2017 and Jul 9, 2025 — classified as 30 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Material Separation” (33 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 55 reports, in the reporter's own words as published by the FDA.

• InjuryJul 9, 2025Break; Break

  THE USER FACILITY REPORTED THAT THE GLIDEWIRE WAS BEING USED TO GO SUBINTIMAL IN AN ATTEMPT TO CROSS A CALCIFIED CHRONIC TOTAL OCCLUSION (CTO) LESION. THE TIP GOT STUCK AND BROKE OFF IN THE LESION WHEN PULLED OUT. THE PROCEDURE PERFORMED WAS A PERIPHERAL ANGIOPLASTY. THERE WAS NO BLOOD LOSS AND NO PATIENT INJURY. ADDITIONAL INFORMATION WAS RECEIVED ON 03JUL2025: THEY LEFT THE PIECE IN THE PATIENT, IT WAS A CALCIFIED CHRONIC TOTAL OCCLUSION (CTO) LESION SO THERE WAS NO HARM TO THE PATIENT, AS THERE WAS ALREADY NO FLOW IN THE VESSEL WHERE THE WIRE TIP BROKE OFF. THE WIRE FRAGMENT WAS APPROXIMATELY 1-2CM.

  Patient problems: Foreign Body In Patient

  MAUDE report 22465614 ↗
• InjuryJul 9, 2025Break; Break

  THE USER FACILITY REPORTED THAT THE GLIDEWIRE WAS BEING USED TO GO SUBINTIMAL IN AN ATTEMPT TO CROSS A CALCIFIED CHRONIC TOTAL OCCLUSION (CTO) LESION. THE TIP GOT STUCK AND BROKE OFF IN THE LESION WHEN PULLED OUT. THE PROCEDURE PERFORMED WAS A PERIPHERAL ANGIOPLASTY. THERE WAS NO BLOOD LOSS AND NO PATIENT INJURY. ADDITIONAL INFORMATION WAS RECEIVED ON 03JUL2025: THEY LEFT THE PIECE IN THE PATIENT, IT WAS A CALCIFIED CHRONIC TOTAL OCCLUSION (CTO) LESION SO THERE WAS NO HARM TO THE PATIENT, AS THERE WAS ALREADY NO FLOW IN THE VESSEL WHERE THE WIRE TIP BROKE OFF. THE WIRE FRAGMENT WAS APPROXIMATELY 1-2CM.

  Patient problems: Foreign Body In Patient

  MAUDE report 22465613 ↗
• InjuryJun 20, 2025Peeled/Delaminated; Peeled/Delaminated

  THE USER FACILITY REPORTED THAT THE DISTAL PORTION OF THE WIRE HAD ITS HYDROPHILIC COATING SHEAR OFF. THIS RESULTED IN CATHETERS BEING UNABLE TO PASS OVER IT AND CAUSED THE PHYSICIAN TO LOSE WIRE ACCESS. THE TYPE OF PROCEDURE PERFORMED WAS A LEG ANGIOGRAM. THE PATIENT'S CONDITION WAS STABLE. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THE EVENT OCCURRED INTRA-OPERATIVE. ADDITIONAL INFORMATION WAS RECEIVED ON 28 MAY 2025: THE SAMPLE IS CONTAMINATED WITH BLOOD BUT NOT WITH INFECTIOUS AGENTS OR ANTI-CANCER AGENTS. THE REPORTED EVENT DID NOT RESULT IN PATIENT INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22298677 ↗
• InjuryJun 20, 2025Peeled/Delaminated; Peeled/Delaminated

  THE USER FACILITY REPORTED THAT THE DISTAL PORTION OF THE WIRE HAD ITS HYDROPHILIC COATING SHEAR OFF. THIS RESULTED IN CATHETERS BEING UNABLE TO PASS OVER IT AND CAUSED THE PHYSICIAN TO LOSE WIRE ACCESS. THE TYPE OF PROCEDURE PERFORMED WAS A LEG ANGIOGRAM. THE PATIENT'S CONDITION WAS STABLE. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THE EVENT OCCURRED INTRA-OPERATIVE. ADDITIONAL INFORMATION WAS RECEIVED ON 28 MAY 2025: THE SAMPLE IS CONTAMINATED WITH BLOOD BUT NOT WITH INFECTIOUS AGENTS OR ANTI-CANCER AGENTS. THE REPORTED EVENT DID NOT RESULT IN PATIENT INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22298675 ↗
• InjuryJan 8, 2024Peeled/Delaminated; Peeled/Delaminated

  THE USER FACILITY REPORTED THAT THE GLIDEWIRES USED IN THE PROCEDURE WERE DAMAGED. THE COATING OF THE WIRES WERE PULLED BACK AND THE INNER WIRE WAS EXPOSED. A PRIME REMOVAL WAS DONE FROM THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 18464225 ↗
• InjuryJan 8, 2024Peeled/Delaminated; Peeled/Delaminated

  THE USER FACILITY REPORTED THAT THE GLIDEWIRES USED IN THE PROCEDURE WERE DAMAGED. THE COATING OF THE WIRES WERE PULLED BACK AND THE INNER WIRE WAS EXPOSED. A PRIME REMOVAL WAS DONE FROM THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 18464213 ↗
• InjuryDec 6, 2023Break; Break

  THE USER FACILITY REPORTED THAT THE TIP OF GLIDEWIRE BROKE OFF DURING CASE AS THEY WERE TRYING TO ADVANCE THROUGH CALCIFIED LESION. THE ESTIMATED BLOOD LOSS WAS UNKNOWN. THEY HAD TO RETRIEVE THE TIP OF THE WIRE. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS THAT THEY HAD TO FINISH BEFORE DONE. ADDITIONAL INFORMATION WAS RECEIVED ON 20JUL2023: THE PROCEDURE BEING PERFORMED WAS A LOWER EXTREMITY ANGIO.

  Patient problems: Foreign Body In Patient

  MAUDE report 18274841 ↗
• InjurySep 3, 2023Peeled/Delaminated; Peeled/Delaminated

  THE USER FACILITY REPORTED THAT THE GLIDEWIRES USED IN THE PROCEDURE WERE DAMAGED. THE COATING OF THE WIRES WERE PULLED BACK AND THE INNER WIRE WAS EXPOSED. A PRIME REMOVAL WAS DONE FROM THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 17675028 ↗
• InjurySep 3, 2023Peeled/Delaminated; Peeled/Delaminated

  THE USER FACILITY REPORTED THAT THE GLIDEWIRES USED IN THE PROCEDURE WERE DAMAGED. THE COATING OF THE WIRES WERE PULLED BACK AND THE INNER WIRE WAS EXPOSED. A PRIME REMOVAL WAS DONE FROM THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 17675027 ↗
• InjuryAug 12, 2023Break; Break

  THE USER FACILITY REPORTED THAT THE TIP OF THE GLIDEWIRE BROKE OFF DURING CASE AS THEY WERE TRYING TO ADVANCE THROUGH CALCIFIED LESION. MEDICAL INTERVENTION WAS REQUIRED TO RETRIEVE THE TIP OF THE WIRE. THE PATIENT CONDITION WAS STABLE. PROCEDURE OUTCOME WAS THEY HAD TO FINISH BEFORE DONE. ADDITIONAL INFORMATION WAS RECEIVED ON 20 JUL 2023: PROCEDURE BEING PERFORMED WAS A LOWER EXTREMITY ANGIOGRAM.

  Patient problems: Foreign Body In Patient

  MAUDE report 17537812 ↗
• MalfunctionSep 22, 2022Break; Material Frayed; Break; Material Frayed

  THE USER FACILITY REPORTED THAT THE TIP OF THE GLIDEWIRE FRACTURED IN THE CASE. THE PATIENT WAS STABLE, AND THE PROCEDURE WAS A SUCCESS. THERE WERE NO OTHER DEVICES OR EQUIPMENT USED WITH THE REPORTED PRODUCT. ADDITIONAL INFORMATION WAS RECEIVED ON 26 AUG 2022: THE TIP OF THE WIRE WAS FRAYED WHEN REMOVED FROM THE PATIENT. THE PROCEDURE PERFORMED WAS A DIAGNOSTIC PERIPHERAL. THERE WERE NO PIECES LEFT BEHIND OR THAT FELL INTO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 30 AUG 2022: THE PHYSICIAN STATED THAT THE WIRE'S MOST PROXIMAL END SHOWED SIGNS OF FLAKING OR CRUMBLING, HOWEVER WHEN THE TERUMO TERRITORY MANAGER LOOKED AT THE DEVICE, AND HE DIDN'T SEE ANY SIGNS OF IT BREAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15462885 ↗
• MalfunctionJul 28, 2022Peeled/Delaminated; Peeled/Delaminated

  THE USER FACILITY REPORTED THAT THE HYDROPHILIC COATING ON THE GUIDEWIRE SEPARATED DURING THE CASE. THE PATIENT WAS NOT HARMED. THE PROCEDURE OUTCOME WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED ON 28 JULY 2022: THE PROCEDURE FOR THE PATIENT AT THE TIME OF EVENT WAS A LEFT LEG ANGIOGRAM WITH INTERVENTION. THEY WERE ABLE TO REMOVE ALL THE COATING FROM THE PATIENT. NO MEDICAL INTERVENTION TOOK PLACE TO REMOVE THE COATING. THE PATIENT WAS IN STABLE CONDITION. A 5FR PROCEDURAL SHEATH WAS REPORTED TO HAVE BEEN USED BY THE RADIOLOGY TECH DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15127314 ↗
• MalfunctionMay 20, 2022Peeled/Delaminated; Peeled/Delaminated

  THE USER FACILITY REPORTED THAT THE OUTSIDE COATING STRIPPED OFF THE WIRE INVOLVED. THE PATIENT WAS NOT INJURED. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 28 APR 2022: THE PROCEDURE PERFORMED WAS A LEG ANGIOGRAM. THE COATING STRIPPED OFF THE WIRE AFTER THE CROSSOVER SHEATH EXCHANGE. THE PATIENT WAS IN STABLE CONDITION. THE COATING WAS NOT LEFT IN THE PATIENT'S BODY. THERE WAS NO BLOOD LOSS. THE PROCEDURE OUTCOME WAS SUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14461078 ↗
• InjuryApr 25, 2022Break; Migration; Break; Migration

  THE USER FACILITY REPORTED THAT THE TIP OF THE STIFF GLIDEWIRE INVOLVED (3-4CM), BROKE OFF INTO THE PATIENT. THE TIP WAS ATTEMPTED TO BE REMOVED FOR TWO HOURS, BUT THE TIP WENT INTO A BRANCH OFF THE PROFUNDA AND WAS LEFT IN THE PATIENT. THE BRANCH OFF WAS TIED TO ENSURE THAT THE PART OF THE WIRE COULD ONLY GO DISTAL AND NOT CAUSE ANY HARM TO THE PATIENT. THE DOCTOR DID NOT PERFORM THE ENDOVASCULAR ILIAC RECANALIZATION (EVAR) PROCEDURE AS INTENDED DUE TO THE WIRE BREAK. THE DOCTOR HAD TO PERFORM A CUTDOWN, ABOUT 6 INCHES ON THE LEFT LEG, TO ACCESS THE BROKEN PIECE OF WIRE. THE PROCEDURE WAS STARTED WITH LEFT GROIN ACCESS VIA A 6 FR SHEATH, A 5 FR VS1 CATHETER, AND THE STIFF GLIDEWIRE INVOLVED IN THE CATHETER. THE DOCTOR WENT UP AND OVER THE ILIAC OCCLUSION, THE DOCTOR WAS BURROWING THE WIRE IN THE OCCLUSION. WHEN THE DOCTOR COULD NOT PASS THE OCCLUSION, HE REMOVED THE WIRE AND NOTICED THE TIP WAS MISSING. A FLUOROSCOPY WAS PERFORMED AND THE BRANCH OF THE PROFUNDA WAS SEEN. THE PATIENT WAS FINE. THERE WAS NO ATHERECTOMY DEVICE OR LASER USED. THERE WAS NO METAL INTRODUCER OR DILATOR USED. THERE WAS NO EXCESSIVE TORQUE. THE PROCEDURE OUTCOME WAS NOT SUCCESSFUL. THERE WAS NO EQUIPMENT O

  Patient problems: Embolism/Embolus; Foreign Body In Patient; Obstruction/Occlusion

  MAUDE report 14192637 ↗
• InjuryApr 25, 2022Break; Migration; Break; Migration

  THE USER FACILITY REPORTED THAT THE TIP OF THE STIFF GLIDEWIRE INVOLVED (3-4CM), BROKE OFF INTO THE PATIENT. THE TIP WAS ATTEMPTED TO BE REMOVED FOR TWO HOURS, BUT THE TIP WENT INTO A BRANCH OFF THE PROFUNDA AND WAS LEFT IN THE PATIENT. THE BRANCH OFF WAS TIED TO ENSURE THAT THE PART OF THE WIRE COULD ONLY GO DISTAL AND NOT CAUSE ANY HARM TO THE PATIENT. THE DOCTOR DID NOT PERFORM THE ENDOVASCULAR ILIAC RECANALIZATION (EVAR) PROCEDURE AS INTENDED DUE TO THE WIRE BREAK. THE DOCTOR HAD TO PERFORM A CUTDOWN, ABOUT 6 INCHES ON THE LEFT LEG, TO ACCESS THE BROKEN PIECE OF WIRE. THE PROCEDURE WAS STARTED WITH LEFT GROIN ACCESS VIA A 6 FR SHEATH, A 5 FR VS1 CATHETER, AND THE STIFF GLIDEWIRE INVOLVED IN THE CATHETER. THE DOCTOR WENT UP AND OVER THE ILIAC OCCLUSION, THE DOCTOR WAS BURROWING THE WIRE IN THE OCCLUSION. WHEN THE DOCTOR COULD NOT PASS THE OCCLUSION, HE REMOVED THE WIRE AND NOTICED THE TIP WAS MISSING. A FLUOROSCOPY WAS PERFORMED AND THE BRANCH OF THE PROFUNDA WAS SEEN. THE PATIENT WAS FINE. THERE WAS NO ATHERECTOMY DEVICE OR LASER USED. THERE WAS NO METAL INTRODUCER OR DILATOR USED. THERE WAS NO EXCESSIVE TORQUE. THE PROCEDURE OUTCOME WAS NOT SUCCESSFUL. THERE WAS NO EQUIPMENT O

  Patient problems: Embolism/Embolus; Foreign Body In Patient; Obstruction/Occlusion

  MAUDE report 14192623 ↗
• MalfunctionApr 25, 2022Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE COATING STRIPPED OFF THE ANGLED STIFF WIRE INVOLVED. ADDITIONAL INFORMATION WAS RECEIVED ON 04 APR 2022: THE PATIENT WAS NOT AFFECTED. ADDITIONAL INFORMATION WAS RECEIVED ON 15 APR 2022: THE PATIENT WAS NOT INJURED. MEDICAL OR SURGICAL INTERVENTION WAS NOT REQUIRED AND THERE WAS NO BLOOD LOSS. THE PROCEDURE PERFORMED WAS A LOWER EXTREMITY (LE) ANGIOGRAM. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS SUCCESSFUL. THE WIRE COATING STRIPPED OFF THE WIRE AFTER THE QUICKCROSS WAS EXCHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14192173 ↗
• InjuryMar 18, 2022Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT DURING AN ABDOMINAL AORTOGRAM WITH RUNOFF VIA THE RIGHT FEMORAL ARTERY, WHEN ATTEMPTING TO CROSS A LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) WITH A NAVICROSS CATHETER AND STIFF ANGLED GLIDEWIRE, A PORTION OF THE TIP OF THE WIRE SHEARED OFF. THE PIECE WAS ATTEMPTED TO BE REMOVED BUT COULD NOT BE DONE. THE PATIENT WOULD HAVE BYPASS SURGERY AS ENDOVASCULAR RECANALIZATION WAS UNSUCCESSFUL. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS COMPLETED.

  Patient problems: Foreign Body In Patient

  MAUDE report 13804449 ↗
• InjuryMar 18, 2022Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT DURING AN ABDOMINAL AORTOGRAM WITH RUNOFF VIA THE RIGHT FEMORAL ARTERY, WHEN ATTEMPTING TO CROSS A LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) WITH A NAVICROSS CATHETER AND STIFF ANGLED GLIDEWIRE, A PORTION OF THE TIP OF THE WIRE SHEARED OFF. THE PIECE WAS ATTEMPTED TO BE REMOVED BUT COULD NOT BE DONE. THE PATIENT WOULD HAVE BYPASS SURGERY AS ENDOVASCULAR RECANALIZATION WAS UNSUCCESSFUL. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS COMPLETED.

  Patient problems: Foreign Body In Patient

  MAUDE report 13804447 ↗
• MalfunctionMar 15, 2022Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE CASING OF THE WIRE INVOLVED SHEARED FROM THE MIDDLE. THE ISSUE WAS NOTICED OUTSIDE OF THE PATIENT AND BEFORE THE PRODUCT WAS USED. A TIP CAME OFF THE BACK END OF THE WIRE. THE PRODUCT WAS NOT USED ON THE PATIENT. THE PATIENT WAS UNAFFECTED. THE PROCEDURE OUTCOME WAS SUCCESSFUL. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 24 FEB 2022: THE WIRE DID NOT HAVE ANY CONTACT WITH OTHER EQUIPMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13769389 ↗
• InjuryJan 6, 2022Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE OUTSIDE COATING OF THE WIRE STRIPPED WHILE ADVANCING THROUGH A MICRO CATHETER IN THE BODY DURING A LOWER EXTREMITY ANGIOGRAM. ADDITIONAL INFORMATION WAS RECEIVED ON 17-DECEMBER-2021: THE WIRE STAYED INSIDE THE MICROCATHETER. THE PATIENT WAS STABLE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PROCEDURE WAS NOT COMPLETED BY USING THE WIRE, EVERYTHING WAS RETRACTED AND EXCHANGED.

  Patient problems: Foreign Body In Patient

  MAUDE report 13180223 ↗
• InjuryJan 6, 2022Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE OUTSIDE COATING OF THE WIRE STRIPPED WHILE ADVANCING THROUGH A MICRO CATHETER IN THE BODY DURING A LOWER EXTREMITY ANGIOGRAM. ADDITIONAL INFORMATION WAS RECEIVED ON 17DECEMBER2021: THE WIRE STAYED INSIDE THE MICROCATHETER. THE PATIENT WAS STABLE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PROCEDURE WAS NOT COMPLETED BY USING THE WIRE, EVERYTHING WAS RETRACTED AND EXCHANGED.

  Patient problems: Foreign Body In Patient

  MAUDE report 13180112 ↗
• MalfunctionOct 26, 2021Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE WIRE WAS IN THE BODY AND THE DOCTOR NOTICED THE COATING WAS STRIPPING AND WIRE WAS EXPOSED. IT WAS THEN PULLED OUT OF PATIENT. THE BLOOD LOSS WAS LESS THAN 250CC. THE CONDITION OF THE PATIENT WAS STABLE. THE PROCEDURE WAS COMPLETED BY SWITCHING THE WIRES. ADDITIONAL INFORMATION WAS RECEIVED ON 05OCT2021. THE TYPE OF PROCEDURE PERFORMED WAS A LEFT LOWER EXTREMITY ANGIOGRAM. THE COATING DID NOT COME OFF INSIDE THE PATIENT. TESTING TO DETERMINE THAT THERE WAS NOTHING LEFT IN THE PATIENT WAS NOT NECESSARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12701959 ↗
• InjuryAug 11, 2021Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT SOMETHING WAS NOTICED ON THE TECH SCREEN. THE TIP OF THE RADIFOCUS WIRE BROKE OFF IN THE PATIENT. THEY CHECKED THE WIRE OFF THE TABLE; TIP WAS SPLIT AND THE PART THAT SPLIT BROKE OFF. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. THE PATIENT'S CONDITION WAS STABLE. ADDITIONAL INFORMATION WAS RECEIVED ON 02AUG2021. THE PROCEDURE BEING PERFORMED WAS A LEFT LEG ANGIOGRAM. THE WIRE WAS LOCATED IN THE PATIENTS LEFT LOWER LEG/ SFA. THE TIP OF THE WIRE WAS NOT RETRIEVED FROM THE PATIENT'S BODY. THERE WAS NO BLOOD LOSS. ONCE THE TIP BROKE THE PROCEDURE WAS PERUSED WITH INTENTIONS TO FIX THE DISTAL OCCLUSION, NO SUCCESS IN GETTING PACK THE BLOCKAGE; NOT DUE TO THE WIRE; DUE TO THE OCCLUSION.

  Patient problems: Foreign Body In Patient

  MAUDE report 12306650 ↗
• InjuryAug 11, 2021Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT SOMETHING WAS NOTICED ON THE TECH SCREEN. THE TIP OF THE RADIFOCUS WIRE BROKE OFF IN THE PATIENT. THEY CHECKED THE WIRE OFF THE TABLE; TIP WAS SPLIT AND THE PART THAT SPLIT BROKE OFF. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. THE PATIENT'S CONDITION WAS STABLE. ADDITIONAL INFORMATION WAS RECEIVED ON 02AUG2021. THE PROCEDURE BEING PERFORMED WAS A LEFT LEG ANGIOGRAM. THE WIRE WAS LOCATED IN THE PATIENTS LEFT LOWER LEG/ SFA. THE TIP OF THE WIRE WAS NOT RETRIEVED FROM THE PATIENT'S BODY. THERE WAS NO BLOOD LOSS. ONCE THE TIP BROKE THE PROCEDURE WAS PERUSED WITH INTENTIONS TO FIX THE DISTAL OCCLUSION, NO SUCCESS IN GETTING PACK THE BLOCKAGE; NOT DUE TO THE WIRE; DUE TO THE OCCLUSION.

  Patient problems: Foreign Body In Patient

  MAUDE report 12306648 ↗
• InjuryJul 13, 2021Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE BLACK COATING SLID OFF THE RADIFOCUS WIRE WHILE IN THE PATIENT. THERE WAS NO PATIENT INJURY. THE PATIENT WAS UNAFFECTED. THE PROCEDURE OUTCOME WAS SUCCESSFUL. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 01JUL2021. THE PROCEDURE TAKING PLACE FOR THE PATIENT AT THE TIME THE ISSUE OCCURRED WAS A LEFT LEG ANGIOPLASTY TO TREAT PAD. THE BLACK COATING SLID OFF IN THE LEFT SFA. FURTHER INVESTIGATION REVEALED THAT THE COATING SLID UP THE WIRE AND BUNCHED UP, ALTHOUGH DID NOT ACTUALLY DETACH FROM THE WIRE, SO NOTHING REMAINED IN THE PATIENT. SINCE THE COATING DID NOT ACTUALLY DETACH FROM THE WIRE, NO INTERVENTION WAS REQUIRED. THERE WAS NO BLOOD LOSS GREATER THAN 250CC. THE PATIENT'S CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12159013 ↗