GLIDECATH CG415Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 04987350772190), received between Mar 23, 2017 and Oct 31, 2025 — classified as 27 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (12 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 28 reports, in the reporter's own words as published by the FDA.

• InjuryOct 31, 2025Fracture; Fracture

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: THE GLIDECATH BROKE IN HALF IN THE BODY. IT WAS STILL ATTACHED TO THE WIRE, AND THEY SNARED IT OUT. ADDITIONAL INFORMATION WAS RECEIVED ON 08OCT2025: THERE WAS NO PATIENT INJURY AND THE PATIENT WAS STABLE. ADDITIONAL INFORMATION WAS RECEIVED ON 09OCT2025: THERE WERE NO FRAGMENTS LEFT IN THE BODY; IT WAS SNARED OUT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23442330 ↗
• InjuryOct 31, 2025Fracture; Fracture

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: THE GLIDECATH BROKE IN HALF IN THE BODY. IT WAS STILL ATTACHED TO THE WIRE, AND THEY SNARED IT OUT. ADDITIONAL INFORMATION WAS RECEIVED ON 08OCT2025: THERE WAS NO PATIENT INJURY AND THE PATIENT WAS STABLE. ADDITIONAL INFORMATION WAS RECEIVED ON 09OCT2025: THERE WERE NO FRAGMENTS LEFT IN THE BODY; IT WAS SNARED OUT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23442328 ↗
• InjuryMar 4, 2025Fracture; Fracture

  THE USER FACILITY REPORTED THAT WHILE INSERTED IN THE AORTA, 15CM'S OF THE TIP BROKE OFF IN THE PATIENT AND IT TOOK AN HOUR FOR IT TO BE RETRIEVED. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2025: THE PROCEDURE PERFORMED WAS AN AORTOGRAM, RIGHT LEG ANGIOGRAM, LEFT ILIAC ANGIOPLASTY, AND RETRIEVAL INTRAVASCULAR DEVICE. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2025: THE PATIENT WAS STABLE AND WENT HOME THE SAME DAY. CATHETER BROKE OFF WHILE CROSSING AN ILIAC STENOSIS GETTING INTO THE ABDOMINAL AORTA FOR AN ANGIOGRAM. BLOOD LOSS WAS MINIMAL. A STIFF AMPLATZ WIRE WAS THROUGH THE CATHETER AT THE TIME IT SNAPPED OFF. IT WAS RETRIEVED WITH A SNARE CATHETER.

  Patient problems: Foreign Body In Patient

  MAUDE report 21521098 ↗
• InjuryMar 4, 2025Fracture; Fracture

  THE USER FACILITY REPORTED THAT WHILE INSERTED IN THE AORTA, 15CM'S OF THE TIP BROKE OFF IN THE PATIENT AND IT TOOK AN HOUR FOR IT TO BE RETRIEVED. ADDITIONAL INFORMATION WAS RECEIVED ON 06FEB2025: THE PROCEDURE PERFORMED WAS AN AORTOGRAM, RIGHT LEG ANGIOGRAM, LEFT ILIAC ANGIOPLASTY, AND RETRIEVAL INTRAVASCULAR DEVICE. ADDITIONAL INFORMATION WAS RECEIVED ON 11FEB2025: THE PATIENT WAS STABLE AND WENT HOME THE SAME DAY. CATHETER BROKE OFF WHILE CROSSING AN ILIAC STENOSIS GETTING INTO THE ABDOMINAL AORTA FOR AN ANGIOGRAM. BLOOD LOSS WAS MINIMAL. A STIFF AMPLATZ WIRE WAS THROUGH THE CATHETER AT THE TIME IT SNAPPED OFF. IT WAS RETRIEVED WITH A SNARE CATHETER.

  Patient problems: Foreign Body In Patient

  MAUDE report 21521095 ↗
• InjuryMay 9, 2024Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE TIP OF AN ENDOVASCULAR "GLIDECATH" WAS NOTED TO BE MISSING AFTER IT WAS REMOVED FROM THE PATIENT. THE SURGEON DID NOT BELIEVE THERE WAS ANY PATIENT HARM, THE PATIENT WAS FINE. THERE WAS NO BLOOD LOSS. THE REPORTED EVENT DID NOT RESULT IN PATIENT INJURY AND/OR REQUIRE MEDICAL OR SURGICAL INTERVENTION. 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 06MAY2024: NO REPORTED ADVERSE PATIENT EFFECT DUE TO THE INCIDENT. THE PROCEDURE WAS SUCCESSFUL.

  Patient problems: Foreign Body In Patient

  MAUDE report 19277736 ↗
• InjuryMay 9, 2024Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE TIP OF AN ENDOVASCULAR "GLIDECATH" WAS NOTED TO BE MISSING AFTER IT WAS REMOVED FROM THE PATIENT. THE SURGEON DID NOT BELIEVE THERE WAS ANY PATIENT HARM, THE PATIENT WAS FINE. THERE WAS NO BLOOD LOSS. THE REPORTED EVENT DID NOT RESULT IN PATIENT INJURY AND/OR REQUIRE MEDICAL OR SURGICAL INTERVENTION. 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 06MAY2024: NO REPORTED ADVERSE PATIENT EFFECT DUE TO THE INCIDENT. THE PROCEDURE WAS SUCCESSFUL.

  Patient problems: Foreign Body In Patient

  MAUDE report 19277666 ↗
• InjuryMar 20, 2024Break; Break

  THE USER FACILITY REPORTED THAT DURING A PERIPHERAL PROCEDURE, THE GLIDECATH WAS OVER THE ILIAC BIFURCATION OVER AN AMPLATZ WIRE. THE DOCTOR WAS REMOVING THE GLIDECATH TO EXCHANGE FOR A NAVICROSS AND FELT SOME RESISTANCE BUT COULD NOT DETERMINE WHAT WAS CAUSING IT. HE PULLED ON THE GLIDECATH AND IT BROKE APART LEAVING APPROXIMATELY 15CM IN THE PATIENT. HE WAS ABLE TO PULL THE WIRE WITH THE REMAINING CATHETER INTO THE DESTINATION SHEATH TO REMOVE SAFELY. THE CASE WAS FINISHED SUCCESSFULLY AND NO HARM TO THE PATIENT. THE PROCEDURE WAS A LEFT LEG ANGIO. THERE WAS NO BLOOD LOSS.

  Patient problems: Foreign Body In Patient

  MAUDE report 18947311 ↗
• InjuryMar 20, 2024Break; Break

  THE USER FACILITY REPORTED THAT DURING A PERIPHERAL PROCEDURE, THE GLIDECATH WAS OVER THE ILIAC BIFURCATION OVER AN AMPLATZ WIRE. THE DOCTOR WAS REMOVING THE GLIDECATH TO EXCHANGE FOR A NAVICROSS AND FELT SOME RESISTANCE BUT COULD NOT DETERMINE WHAT WAS CAUSING IT. HE PULLED ON THE GLIDECATH AND IT BROKE APART LEAVING APPROXIMATELY 15CM IN THE PATIENT. HE WAS ABLE TO PULL THE WIRE WITH THE REMAINING CATHETER INTO THE DESTINATION SHEATH TO REMOVE SAFELY. THE CASE WAS FINISHED SUCCESSFULLY AND NO HARM TO THE PATIENT. THE PROCEDURE WAS A LEFT LEG ANGIO. THERE WAS NO BLOOD LOSS.

  Patient problems: Foreign Body In Patient

  MAUDE report 18947310 ↗
• InjuryJan 8, 2024Break; Break

  THE USER FACILITY REPORTED THAT THE CATHETER BROKE INSIDE THE PATIENT AND DISTAL END HAD TO BE RETRIEVED WITH A SNARE. IT APPEARED THE CATHETER WAS SHEARED DUE TO THE BIOPSY DEVICE. THE PATIENT WAS STABLE AND THERE WAS NO ISSUE POST OPERATION. THE PROCEDURE BEING PERFORMED WAS TRANS JUGULAR LIVER BIOPSY. NO ESTIMATED BLOOD LOSS. THERE WAS NO PATIENT INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 18463824 ↗
• InjuryNov 21, 2023Break; Break

  TERUMO MEDICAL RECEIVED AN FDA MEDWATCH REPORT # MW (B)(4). THE EVENT DESCRIPTION STATES THAT DURING AN AORTOGRAM WITH LEFT LEG ANGIOGRAM A 4FR ANGLED GLIDE CATHETER BROKE, LEAVING A LARGE REMANENT IN THE PATIENT. THE CATHETER WAS APPROPRIATELY FLUSHED PRE-OP DURING PROCEDURE SET UP AND NO DAMAGE WAS NOTED. WHEN THE MD ADVANCED THE GLIDEWIRE ADVANTAGE THROUGH THE CATHETER, HE FELT A SNAP AND TRIED TO PULL THE CATHETER OUT, THAT'S WHEN HE NOTICED THE CATHETER HAD BROKEN OFF. AN AORTOGRAM WAS PERFORMED, AND A REMANENT PIECE OF THE CATHETER WAS ABLE TO BE SNARED OUT. THE CATHETER AND REMAINING REMANENT WERE PLACED IN BIOHAZARD BAG AND GIVEN TO ASSISTANT MANAGER AS THIS APPEARS TO BE A MANUFACTURER ISSUE. THE ORIGINAL INTENDED PROCEDURE WAS AN ULTRASOUND-GUIDED ACCESS OF BILATERAL COMMON FEMORAL ARTERIES, NONSELECTIVE CATHETER PLACEMENT AORTA TIMES TWO. STENTING OF BILATERAL COMMON ILIAC ARTERIES USING AN 8 X 37 VISI PRO STENT ON THE LEFT AND AN 8 X 27 VISI PRO STENT ON THE RIGHT WAS PERFORMED. PERCUTANEOUS CLOSURE OF BILATERAL COMMON FEMORAL ARTERIES USING TWO, 6 FRENCH ANGIO-SEALS WAS DONE. THE DEVICE DID NOT FUNCTION AS INTENDED. (E.G., BROKE, COULD NOT GET IT TO WORK OR STOPPED WOR

  Patient problems: Foreign Body In Patient

  MAUDE report 18182001 ↗
• InjuryNov 21, 2023Break; Break

  TERUMO MEDICAL RECEIVED AN FDA MEDWATCH REPORT#: (B)(4). THE EVENT DESCRIPTION STATES THAT DURING AN AORTOGRAM WITH LEFT LEG ANGIOGRAM A 4FR ANGLED GLIDE CATHETER BROKE, LEAVING A LARGE REMANENT IN THE PATIENT. THE CATHETER WAS APPROPRIATELY FLUSHED PRE-OP DURING PROCEDURE SET UP AND NO DAMAGE WAS NOTED. WHEN THE MD ADVANCED THE GLIDEWIRE ADVANTAGE THROUGH THE CATHETER, HE FELT A SNAP AND TRIED TO PULL THE CATHETER OUT, THAT'S WHEN HE NOTICED THE CATHETER HAD BROKEN OFF. AN AORTOGRAM WAS PERFORMED, AND A REMANENT PIECE OF THE CATHETER WAS ABLE TO BE SNARED OUT. THE CATHETER AND REMAINING REMANENT WERE PLACED IN BIOHAZARD BAG AND GIVEN TO ASSISTANT MANAGER AS THIS APPEARS TO BE A MANUFACTURER ISSUE. THE ORIGINAL INTENDED PROCEDURE WAS AN ULTRASOUND-GUIDED ACCESS OF BILATERAL COMMON FEMORAL ARTERIES, NONSELECTIVE CATHETER PLACEMENT AORTA TIMES TWO. STENTING OF BILATERAL COMMON ILIAC ARTERIES USING AN 8 X 37 VISI PRO STENT ON THE LEFT AND AN 8 X 27 VISI PRO STENT ON THE RIGHT WAS PERFORMED. PERCUTANEOUS CLOSURE OF BILATERAL COMMON FEMORAL ARTERIES USING TWO, 6 FRENCH ANGIO-SEALS WAS DONE. THE DEVICE DID NOT FUNCTION AS INTENDED. (E.G., BROKE, COULD NOT GET IT TO WORK OR STOPPED WORKIN

  Patient problems: Foreign Body In Patient

  MAUDE report 18181880 ↗
• InjurySep 23, 2023Break; Break

  THE USER FACILITY REPORTED THAT THE CATHETER BROKE INSIDE THE PATIENT AND DISTAL END HAD TO BE RETRIEVED WITH A SNARE. LOOKS LIKE CATHETER WAS SHEARED DUE TO THE BIOPSY DEVICE. THE PATIENT WAS STABLE AND THERE WAS NO ISSUE POST OPERATION. THE PATIENT HAS HISTORY OF LIVER CANCER. PROCEDURE BEING PERFORMED WAS A TRANS JUGULAR LIVER BIOPSY. THERE WAS NO ESTIMATED BLOOD LOSS.

  Patient problems: Foreign Body In Patient

  MAUDE report 17804928 ↗
• InjuryFeb 16, 2023Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE DOCTOR USED THE GLIDECATH DEVICE INVOLVED (CG415) TO DELIVER .035 COILS DURING A TYPE II ENDO LEAK CASE. THE DEVICE WAS PLACED UP THE PATIENT'S LEG OF A COVERED STENT GRAFT AND INTO THE ANEURYSM SACK. UPON DELIVERY OF THE DEVICE, AN .035 AZUR COIL ITEM (45-751632) THE DOCTOR NOTICED THAT THE COIL WAS STUCK AND UNABLE TO ADVANCE OR WITHDRAW FROM THE CATHETER. UPON ADDITIONAL EFFORT THE COIL BECAME DETACHED FROM THE COIL WIRE. UPON FURTHER MANIPULATION TO TRY AND DELIVER THE COIL AND WITH DRAW THE CATHETER THE TIP OF THE CATHETER, THE DEVICE INVOLVED SEPARATED WHILE THE BACK PORTION CAME OUT. THE PATIENT WAS IN STABLE CONDITION AND THE CASE WAS ABLE TO PROCEED; HOWEVER, A PORTION OF THE DEVICE WAS LEFT IN THE PATIENT. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH A DIFFERENT CATHETER. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 27 JAN 2023: THE APPROXIMATE SIZE OF THE CATHETER TIP THAT WAS LEFT IN THE PATIENT WAS 5 CENTIMETERS. NO ADDITIONAL INTERVENTION WAS PLANNED TO REMOVE THE CATHETER TIP. THE DOCTOR DECIDED TO LEAVE THE CATHETER PIECE AND PROCEED WITH COILING THE AREA WITH A DIFFE

  Patient problems: Foreign Body In Patient

  MAUDE report 16385434 ↗
• InjuryFeb 16, 2023Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE DOCTOR USED THE GLIDECATH DEVICE INVOLVED (CG415) TO DELIVER .035 COILS DURING A TYPE II ENDO LEAK CASE. THE DEVICE WAS PLACED UP THE PATIENT'S LEG OF A COVERED STENT GRAFT AND INTO THE ANEURYSM SACK. UPON DELIVERY OF THE DEVICE, AN .035 AZUR COIL ITEM (45-751632) THE DOCTOR NOTICED THAT THE COIL WAS STUCK AND UNABLE TO ADVANCE OR WITHDRAW FROM THE CATHETER. UPON ADDITIONAL EFFORT THE COIL BECAME DETACHED FROM THE COIL WIRE. UPON FURTHER MANIPULATION TO TRY AND DELIVER THE COIL AND WITH DRAW THE CATHETER THE TIP OF THE CATHETER, THE DEVICE INVOLVED SEPARATED WHILE THE BACK PORTION CAME OUT. THE PATIENT WAS IN STABLE CONDITION AND THE CASE WAS ABLE TO PROCEED; HOWEVER, A PORTION OF THE DEVICE WAS LEFT IN THE PATIENT. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH A DIFFERENT CATHETER. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 27 JAN 2023: THE APPROXIMATE SIZE OF THE CATHETER TIP THAT WAS LEFT IN THE PATIENT WAS 5 CENTIMETERS. NO ADDITIONAL INTERVENTION WAS PLANNED TO REMOVE THE CATHETER TIP. THE DOCTOR DECIDED TO LEAVE THE CATHETER PIECE AND PROCEED WITH COILING THE AREA WITH A DIFFE

  Patient problems: Foreign Body In Patient

  MAUDE report 16385427 ↗
• InjuryApr 22, 2022Material Separation; Material Separation

  TERUMO MEDICAL RECEIVED A USER FACILITY MEDWATCH REPORT #(B)(4). THE EVENT DESCRIPTION STATES: "THE USER FACILITY REPORTED THAT THE GLIDECATH DEVICE INVOLVED WAS USED FOR AN ENDOVASCULAR INTERVENTION ON THE PATIENT'S AORTA. WHEN THE DEVICE WAS PULLED OUT, APPROXIMATELY 12 CENTIMETERS SHEARED OFF AND WAS LEFT INSIDE THE PATIENT'S AORTA. THE SURGICAL TEAM SPENT APPROXIMATELY 30 MINUTES REMOVING THE BROKEN PIECES AND WAS ABLE SUCCESSFULLY REMOVED THEM ALL. THERE WERE NO SIGNIFICANT COMPLICATIONS, BUT THE EVENT COULD HAVE BEEN A CATASTROPHE. THE ORIGINAL INTENDED PROCEDURES WERE AN AORTOGRAPHY, ABDOMINAL, BY SERIALOGRAPHY WITH RADIOLOGICAL SUPERVISION/INTERPRETATION AND A THROMBOENDARTERECTOMY, PATCH GRAFT IN THE COMMON FEMORAL ARTERY." ADDITIONAL INFORMATION WAS RECEIVED ON 08 APR 2022: THERE WAS NO BLOOD LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14189329 ↗
• InjuryApr 22, 2022Material Separation; Material Separation

  TERUMO MEDICAL RECEIVED A USER FACILITY MEDWATCH REPORT #(B)(4). THE EVENT DESCRIPTION STATES: "THE USER FACILITY REPORTED THAT THE GLIDECATH DEVICE INVOLVED WAS USED FOR AN ENDOVASCULAR INTERVENTION ON THE PATIENT'S AORTA. WHEN THE DEVICE WAS PULLED OUT, APPROXIMATELY 12 CENTIMETERS SHEARED OFF AND WAS LEFT INSIDE THE PATIENT'S AORTA. THE SURGICAL TEAM SPENT APPROXIMATELY 30 MINUTES REMOVING THE BROKEN PIECES AND WAS ABLE SUCCESSFULLY REMOVED THEM ALL. THERE WERE NO SIGNIFICANT COMPLICATIONS, BUT THE EVENT COULD HAVE BEEN A CATASTROPHE. THE ORIGINAL INTENDED PROCEDURES WERE AN AORTOGRAPHY, ABDOMINAL, BY SERIALOGRAPHY WITH RADIOLOGICAL SUPERVISION/INTERPRETATION AND A THROMBOENDARTERECTOMY, PATCH GRAFT IN THE COMMON FEMORAL ARTERY." ADDITIONAL INFORMATION WAS RECEIVED ON 08 APR 2022: THERE WAS NO BLOOD LOSS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14187502 ↗
• InjuryMar 24, 2022Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE GLIDECATH DEVICE INVOLVED WAS USED TO TREAT A PATIENT WITH IN-STENT RESTENOSIS OF THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). THE ENTIRE LENGTH OF THE SFA WAS STENTED. THE 4FR 65 CENTIMETER ANGLED GLIDECATH WAS USED TO ACCESS THE PROXIMAL PORTION OF THE STENT OVER A 0.035" 260 CENTIMETER GLIDEWIRE ADVANTAGE. THE GLIDECATH GOT STUCK IN A PROXIMAL LESION WITHIN THE STENT, AND A LARGE PORTION OF THE CATHETER SHEARED OFF WHEN IT WAS ATTEMPTED TO BE REMOVED. ABOUT HALF OF THE GLIDECATH WAS SHEARED. THE SEGMENT THAT SHEARED OFF WAS EASILY SNARED AND RETRIEVED FROM THE PATIENT. THERE WAS NO EFFECT TO THE PATIENT. THE OUTCOME OF THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT INJURY OR SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 01 MAR 2022: THE PATIENT WAS IN STABLE CONDITION. ALL SHEARED CATHETER PIECES WERE RETRIEVED FROM THE PATIENT. HEMOSTASIS WAS ACHIEVED BY MANUAL COMPRESSION. THERE WAS NO BLOOD LOSS. THE CATHETER WAS DAMAGED AND THE CATHETER WAS IN TWO PIECES WHEN REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13892843 ↗
• InjuryMar 24, 2022Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE GLIDECATH DEVICE INVOLVED WAS USED TO TREAT A PATIENT WITH IN-STENT RESTENOSIS OF THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). THE ENTIRE LENGTH OF THE SFA WAS STENTED. THE 4FR 65 CENTIMETER ANGLED GLIDECATH WAS USED TO ACCESS THE PROXIMAL PORTION OF THE STENT OVER A 0.035" 260 CENTIMETER GLIDEWIRE ADVANTAGE. THE GLIDECATH GOT STUCK IN A PROXIMAL LESION WITHIN THE STENT, AND A LARGE PORTION OF THE CATHETER SHEARED OFF WHEN IT WAS ATTEMPTED TO BE REMOVED. ABOUT HALF OF THE GLIDECATH WAS SHEARED. THE SEGMENT THAT SHEARED OFF WAS EASILY SNARED AND RETRIEVED FROM THE PATIENT. THERE WAS NO EFFECT TO THE PATIENT. THE OUTCOME OF THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT INJURY OR SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 01 MAR 2022: THE PATIENT WAS IN STABLE CONDITION. ALL SHEARED CATHETER PIECES WERE RETRIEVED FROM THE PATIENT. HEMOSTASIS WAS ACHIEVED BY MANUAL COMPRESSION. THERE WAS NO BLOOD LOSS. THE CATHETER WAS DAMAGED AND THE CATHETER WAS IN TWO PIECES WHEN REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13892641 ↗
• InjuryJun 22, 2021Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE INVOLVED GLIDECATH WAS USED INTRA-OPERATIVE. THEY WERE DOING A CONTRA LATERAL RETROGRADE ACCESS FOR A DIAGNOSTIC ANGIOGRAM OF THE LOWER EXTREMITY. THEY ACCESSED THE RIGHT AND WERE GOING UP THE AORTIC BIFURCATION AND TO THE OTHER SIDE. ADVANCING THE WIRE FIRST, THEN THE CATHETER, AND WHEN THE DOCTOR WAS ADVANCING OVER THE BIFURCATION THE FRONT END DETACHED FROM THE SECOND HALF. THE CATHETER BROKE IN TWO PIECES AND THEN THE DOCTOR HAD TO SNARE THE DISTAL END TO REMOVE FROM THE PATIENT BODY. THE PATIENT WAS FINE AND WAS IN STABLE CONDITION. THERE WAS NO BLOOD LOSS. THERE IS NOT A DIRECT ALLEGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12041617 ↗
• InjuryJun 22, 2021Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE INVOLVED GLIDECATH WAS USED INTRA-OPERATIVE. THEY WERE DOING A CONTRA LATERAL RETROGRADE ACCESS FOR A DIAGNOSTIC ANGIOGRAM OF THE LOWER EXTREMITY. THEY ACCESSED THE RIGHT AND WERE GOING UP THE AORTIC BIFURCATION AND TO THE OTHER SIDE. ADVANCING THE WIRE FIRST, THEN THE CATHETER, AND WHEN THE DOCTOR WAS ADVANCING OVER THE BIFURCATION THE FRONT END DETACHED FROM THE SECOND HALF. THE CATHETER BROKE IN TWO PIECES AND THEN THE DOCTOR HAD TO SNARE THE DISTAL END TO REMOVE FROM THE PATIENT BODY. THE PATIENT WAS FINE AND WAS IN STABLE CONDITION. THERE WAS NO BLOOD LOSS. THERE IS NOT A DIRECT ALLEGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12041605 ↗
• MalfunctionMay 19, 2021Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT DURING AN ARTERIOGRAM, THE GLIDECATH (CG415) BROKE IN HALF. THE PHYSICIAN, WHILE NAVIGATING TORTUOUS ILIAC ARTERIES AND THROUGH A AN 8FR 45CM SHEATH, EXCHANGED WIRES FROM A GLIDEWIRE TO A VERSA CORE AND SUBSEQUENTLY A AM PLATZ WIRE. THE GLIDECATH SEPARATED AND IN HALF. THE ENTIRE CATHETER WAS SAFELY REMOVED, AND DIAGNOSTIC ANGIOGRAM WAS COMPLETED. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. THE PATIENT'S CONDITION WAS STABLE. THE PROCEDURE OUTCOME WAS SUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11847767 ↗
• InjuryMay 15, 2020Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED ON 19MAY2020. BLOOD LOSS WAS LESS THAN250CC.

  Patient problems: Blood Loss; No Code Available

  MAUDE report 10061749 ↗
• InjuryMay 15, 2020Break; Break

  TERUMO MEDICAL RECEIVED A USER FACILITY MEDWATCH REPORT # (B)(4). THE EVENT DESCRIPTION STATES: "THE PROCEDURE WITH THIS DEVICE WAS AN ATTEMPT TO REVASCULARIZE THE RIGHT EXTERNAL ILIAC ARTERY STENOSIS. THE ATTEMPT WAS THWARTED BECAUSE THE INTRA-LUMINAL CATHETER BROKE AT THE DISTAL TIP. IT WAS RETRIEVED FROM THE PATIENT'S VASCULATURE IN ITS ENTIRETY BY TRANSFEMORAL WIRE AND SHEATH ACCESS. A GLIDEWIRE WAS ADVANCED ANTEGRADE ACROSS THE EXTERNAL ILIAC ARTERY STENOSIS, ACROSS THE COMMON FEMORAL AND SUPERFICIAL FEMORAL ARTERIES. A 4 FRENCH ANGLED GLIDE CATH WAS ADVANCED OVER THE WIRE AND WAS USED TO EXCHANGE THE STIFF, ANGLED GLIDEWIRE FOR AN AMPLATZ WIRE. WHILE WITHDRAWING THE ANGLED GLIDE CATHETER OVER THE WIRE THE DISTAL END OF IT BROKE OFF, BUT REMAINED ON THE AMPLATZ WIRE." THE ORIGINAL INTENDED PROCEDURE: ULTRASOUND GUIDED PERCUTANEOUS ACCESS OF BILATERAL COMMON FEMORAL ARTERIES; AORTOGRAM WITH RIGHT LOWER EXTREMITY WITH REMOVAL OF FRACTURE CATHETER."

  Patient problems: No Code Available

  MAUDE report 10061748 ↗
• InjuryJan 22, 2020Break; Break

  THE USER FACILITY REPORTED THAT THE INVOLVED NON-TAPER ANGLED GLIDECATH BROKE OFF DURING THE PROCEDURE. THE PATIENT WAS IN STABLE CONDITION. ADDITIONAL INFORMATION WAS RECEIVED ON 20NOV2019. THE DOCTOR HAD TO SNARE THE BROKEN CATH. ADDITIONAL INFORMATION WAS RECEIVED ON 18DEC2019. DURING THE PROCEDURE, THE DISTAL END OF CATHETER BROKE OFF INSIDE PATIENT'S AORTA. THE PHYSICIAN WAS ABLE TO SNARE PIECE THAT BROKE OFF AND REMOVED IT FROM BODY; THE COMPLETE CATHETER TIP WAS REMOVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9615903 ↗
• InjuryJan 22, 2020Break; Break

  THE USER FACILITY REPORTED THAT THE INVOLVED NON-TAPER ANGLED GLIDECATH BROKE OFF DURING THE PROCEDURE. THE PATIENT WAS IN STABLE CONDITION. ADDITIONAL INFORMATION WAS RECEIVED ON 20NOV2019. THE DOCTOR HAD TO SNARE THE BROKEN CATH. ADDITIONAL INFORMATION WAS RECEIVED ON 18DEC2019. DURING THE PROCEDURE, THE DISTAL END OF CATHETER BROKE OFF INSIDE PATIENT'S AORTA. THE PHYSICIAN WAS ABLE TO SNARE PIECE THAT BROKE OFF AND REMOVED IT FROM BODY; THE COMPLETE CATHETER TIP WAS REMOVED.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 9615878 ↗