GLIDESHEATH SLENDER 80-1060Recalls & reported problems

Summary

The FDA's MAUDE database contains 192 adverse event reports that list this exact device (DI 00389701012063), received between Jul 25, 2018 and Jul 15, 2025 — classified as 19 injuries, 173 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (70 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 192 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2025Mechanical Problem; Mechanical Problem

  THE USER FACILITY REPORTED THAT THE SHEATH WAS OPENED, AND ACCESS WAS OBTAINED WITH THE NEEDLE. THE WIRE WAS ATTEMPTED TO BE PLACED THROUGH THE NEEDLE; HOWEVER, IT WOULD NOT THREAD. A NEW SHEATH WAS OPENED AND A NEW WIRE PASSED WITH NO ISSUES. AFTER THE CASE, IT WAS NOTICED THAT THE FIRST WIRE WOULD NOT PASS THROUGH EITHER NEEDLE THAT WAS ON THE TABLE. THE PATIENT WAS STABLE, AND THERE WERE NO ISSUES. NO BLOOD LOSS WAS REPORTED. THE REPORTED EVENT DID NOT RESULT IN PATIENT INJURY AND/OR REQUIRE MEDICAL OR SURGICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22509004 ↗
• MalfunctionMay 2, 2025Activation, Positioning or Separation Problem; Difficult to Open or Close

  THE TIP OF THE DILATOR IS NOT OPEN. WE CANNOT PASS A WIRE THROUGH. WE HAD TO OPEN A NEW SHEATH. NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21949925 ↗
• MalfunctionApr 4, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE USER FACILITY REPORTED THAT THE SHEATH WAS LEAKING BLOOD DURING A HEART CATHETERIZATION PROCEDURE. THE BLOOD LOSS WAS GREATER THAN 250 CC. THE REPORTED EVENT DID NOT RESULT IN PATIENT INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION. ADDITIONAL INFORMATION RECEIVED ON 12 MAR 2025: THE PROCEDURE WAS A HEART CATHETERIZATION. THERE WAS NO NOTICEABLE DAMAGE TO THE DEVICE, BUT IT WAS LEAKING FROM THE VALVE. THE PROCEDURE WAS SUCCESSFUL. ADDITIONAL INFORMATION RECEIVED ON 17 MAR 2025: THE PATIENT IS STABLE. IT CANNOT BE CONFIRMED IF THE BLOOD LOSS WAS GREATER THAN 250 CC OR IF THE DOCTOR USED ANOTHER SHEATH. ADDITIONAL INFORMATION RECEIVED ON 31 MAR 2025: THE BLOOD LOSS WAS LESS THAN 250 CC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21774382 ↗
• InjuryMar 19, 2025Break; Break

  THE USER FACILITY REPORTED THAT DURING A LEFT HEART CATHETERIZATION, THE DOCTOR WAS TRYING TO INSERT SHEATH INTO THE RADIAL ARTERY. HE ONLY GOT A SMALL PORTION OF THE SHEATH INTO THE ARTERY, AND IT WOULD NOT ADVANCE. UPON REMOVAL OF SHEATH THE DOCTOR NOTICED THE TIP OF THE DILATOR WAS BLUNT. WHEN THEY COMPARED TO A NEW ONE IT WAS APPROXIMATELY 10MM SHORTER THAN THE NEW ONE. THE DOCTOR DECIDED TO FLUORO THE WRIST AND THEY NOTICED THERE WAS A FOREIGN OBJECT IN THE LOCATION OF THE RADIAL ARTERY. THE DOCTOR DECIDED TO CONSULT VASCULAR SURGERY. THE WIRE WAS REMOVED, AND A TR BAND WAS PLACED. THERE WAS NO BLOOD LOSS. ADDITIONAL INFORMATION WAS RECEIVED ON 21FEB2025: THE FOREIGN OBJECT WAS THE TIP OF THE DILATOR. IT WAS REMOVED BY VASCULAR SURGERY. THE SAMPLE WAS IN THE PATIENT, YES HAS BLOOD ON AND IN SHEATH. THE DOCTOR STATED THAT USAGE OF THE DEVICE FELT THE SAME AS EVERY OTHER TIME HE HAS USED IT IN THE PAST. THE PATIENT WAS STABLE AND DISCHARGED FROM HOSPITAL ON (B)(6) 2025. THERE WAS NO ISSUE WITH THE TR BAND AS IT ACHIEVED HEMOSTASIS.

  Patient problems: Foreign Body In Patient

  MAUDE report 21642162 ↗
• MalfunctionMar 13, 2025Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THE SHEATH WAS REPORTED VIA AND INVENTORY COORDINATOR AS A LEAKY SHEATH. NO PATIENT HARM WAS REPORTED DUE TO THIS DIFFICULTY. THE BLOOD LOSS WAS LESS THAN 250CC'S. THE PROCEDURE WAS A LEFT HEART CATHETERIZATION. ADDITIONAL INFORMATION WAS RECEIVED ON 05MAR2025: THE CHECK VALVE OF THE SHEATH WAS LEAKING. THE LAB DESCRIBED THAT IT WAS MOST LIKELY A 5 FRENCH TERUMO TIG CATHETER AS THE SOLE DEVICE THROUGH THE VALVE OF THE SHEATH. IT WAS UNKNOWN WHAT WAS DONE TO RESOLVE THE LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21596976 ↗
• MalfunctionFeb 18, 2025Leak/Splash; Leak/Splash

  TERUMO MEDICAL RECEIVED AN FDA MEDWATCH REPORT # MW5164171. THE EVENT DESCRIPTION STATES THAT "BLOOD WAS LEAKING OUT THE PORT' ON THE ACCESS SIDE OF THE SHEATH (THE PART THAT REMAINS OUTSIDE OF THE PATIENT). THIS IS SUPPOSED TO BE A ONE-WAY VALVE TO PREVENT BLOOD FROM LEAKING OUT OF THE SHEATH." ADDITIONAL INFORMATION WAS RECEIVED ON 21 JAN 2025: THE PATIENT'S CONDITION WAS STABLE. THE BLOOD LEAKAGE WAS MINIMAL, LESS THAN 10 ML, SO IT WAS LESS THAN 250 ML. THE PROCEDURE TAKING PLACE AT THE TIME THE BLOOD LEAKAGE OCCURRED WAS CARDIAC CATHETERIZATION. TO RESOLVE THE ISSUE AND CONTINUE THE PROCEDURE, A NEW SHEATH WAS OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21392591 ↗
• MalfunctionJan 10, 2025Positioning Problem; Positioning Problem

  THE USER FACILITY REPORTED THAT THE INTRODUCER WIRE WOULD NOT PASS THROUGH THE NEEDLE. THEY HAD TO RE-STICK TO START THE CASE. THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION WAS RECEIVED ON 07JAN2025: THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21124537 ↗
• MalfunctionDec 31, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  THE USER FACILITY REPORTED THAT THE MEDICAL DOCTOR (MD) USED AN ACCESS KIT FOR THE LEFT HEART CATHETERIZATION (LHC) PROCEDURE. AFTER THE CASE, THE MD INFORMED THE TERUMO REPRESENTATIVE THAT WHEN INSERTING THE WIRE INTO THE NEEDLE, THE TACTILE FEEL WAS ROUGH, DESCRIBING IT AS "GRITTY" AND SIMILAR TO THE SENSATION WHEN THE WIRE IS GOING SUBINTIMAL. BLEED BACK CONFIRMED THAT THE WIRE WAS NOT SUBINTIMAL DURING VESSEL ACCESS. THE PATIENT'S CONDITION WAS STABLE. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THERE WAS NO REPORTED BLOOD LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21045407 ↗
• MalfunctionNov 5, 2024Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  THE USER FACILITY REPORTED THAT A CORONARY PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED. BLEED BACK FROM HUB VALVE, BENDS, AND RUPTURES MID-SHEATH WERE REPORTED. THE PHYSICIAN STATED THAT THE PROCEDURE WAS ABLE TO BE COMPLETED AS INSERTION OF THE CATHETER STOPPED THE VALVE FROM BLEEDING. HOWEVER, ONCE THE CATHETER WAS REMOVED, THE VALVE BEGAN TO BLEED AGAIN. THE BLOOD LOSS WAS LESS THAN 250CC'S. THE REPORTED EVENT DID NOT RESULT IN PATIENT INJURY AND/OR REQUIRE MEDICAL OR SURGICAL INTERVENTION. ADDITIONAL INFORMATION WAS RECEIVED ON 16OCT2024: THE PATIENT WAS STABLE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE VALVE DID NOT HAVE NOTICEABLE DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20610989 ↗
• MalfunctionOct 19, 2024Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THE INVOLVED GLIDESHEATH SLENDER (GSS) DEVICE RADIAL SHEATH LEAKED DURING THE PROCEDURE. THERE WAS A PULSATILE FLOW FROM THE VALVE BETWEEN EACH CATHETER EXCHANGE AND REMOVAL. UNFORTUNATELY, THE AFFECTED SHEATH WAS DISCARDED AND NOT RETRIEVABLE. DESPITE THE LEAKAGE, THE PATIENT WAS NOT NEGATIVELY AFFECTED, AND THE PROCEDURE WAS SUCCESSFUL. THE PATIENT UNDERWENT A HEART CATHETERIZATION PROCEDURE. THERE WERE NO PRE-EXISTING CONDITIONS OR RELEVANT TESTS NOTED. THE PROCEDURE RESULTED IN MINIMAL BLOOD LOSS, LESS THAN 250CC, AND THERE WERE NO INJURIES REPORTED. ADDITIONALLY, THERE WERE NO DIRECT ALLEGATION MADE. ADDITIONAL INFORMATION WAS RECEIVED ON 29 AUG 2024: THE ORIGINAL GSS WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20488899 ↗
• MalfunctionSep 21, 2024Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THE INVOLVED GLIDESHEATH SLENDER (GSS) DEVICE RADIAL SHEATH LEAKED DURING THE PROCEDURE. THERE WAS A PULSATILE FLOW FROM THE VALVE BETWEEN EACH CATHETER EXCHANGE AND REMOVAL. UNFORTUNATELY, THE AFFECTED SHEATH WAS DISCARDED AND NOT RETRIEVABLE. DESPITE THE LEAKAGE, THE PATIENT WAS NOT NEGATIVELY AFFECTED, AND THE PROCEDURE WAS SUCCESSFUL. THE PATIENT UNDERWENT A HEART CATHETERIZATION PROCEDURE. THERE WERE NO PRE-EXISTING CONDITIONS OR RELEVANT TESTS NOTED. THE PROCEDURE RESULTED IN MINIMAL BLOOD LOSS, LESS THAN 250CC, AND THERE WERE NO INJURIES REPORTED. ADDITIONALLY, THERE WERE NO DIRECT ALLEGATIONS ASSOCIATED WITH THE PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED ON 29 AUG 2024: THE ORIGINAL GSS WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20275590 ↗
• MalfunctionSep 21, 2024Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THE INVOLVED GLIDESHEATH SLENDER (GSS) DEVICE RADIAL SHEATH LEAKED DURING THE PROCEDURE. THERE WAS A PULSATILE FLOW FROM THE VALVE BETWEEN EACH CATHETER EXCHANGE AND REMOVAL. UNFORTUNATELY, THE AFFECTED SHEATH WAS DISCARDED AND NOT RETRIEVABLE. DESPITE THE LEAKAGE, THE PATIENT WAS NOT NEGATIVELY AFFECTED, AND THE PROCEDURE WAS SUCCESSFUL. THE PATIENT UNDERWENT A RADIAL PROCEDURE WITH NO PRE-EXISTING CONDITIONS OR RELEVANT TESTS NOTED. THE PROCEDURE RESULTED IN MINIMAL BLOOD LOSS, LESS THAN 250CC, AND THERE WERE NO INJURIES REPORTED. ADDITIONALLY, THERE WERE NO DIRECT ALLEGATIONS MADE. ADDITIONAL INFORMATION WAS RECEIVED ON 29 AUG 2024: THE ORIGINAL GSS WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20275589 ↗
• MalfunctionSep 21, 2024Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THE INVOLVED GLIDESHEATH SLENDER (GSS) DEVICE RADIAL SHEATH LEAKED DURING THE PROCEDURE. THERE WAS A PULSATILE FLOW FROM THE VALVE BETWEEN EACH CATHETER EXCHANGE AND REMOVAL. UNFORTUNATELY, THE AFFECTED SHEATH WAS DISCARDED AND NOT RETRIEVABLE. DESPITE THE LEAKAGE, THE PATIENT WAS NOT NEGATIVELY AFFECTED, AND THE PROCEDURE WAS SUCCESSFUL. THE PATIENT UNDERWENT A HEART CATHETERIZATION PROCEDURE. THERE WERE NO PRE-EXISTING CONDITIONS OR RELEVANT TESTS NOTED. THE PROCEDURE RESULTED IN MINIMAL BLOOD LOSS, LESS THAN 250CC, AND THERE WERE NO INJURIES REPORTED. ADDITIONALLY, THERE WERE NO DIRECT ALLEGATION MADE. ADDITIONAL INFORMATION WAS RECEIVED ON 29 AUG 2024: THE ORIGINAL GSS WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20275588 ↗
• MalfunctionSep 12, 2024Material Separation; Failure to Advance; Physical Resistance/Sticking; Material Separation; Failure to Advance; Physical Resistance/Sticking

  THE USER FACILITY REPORTED THAT THE SHAFT OF THE SHEATH CAME APART FROM THE HUB AS A 6 FRENCH GUIDE WAS BEING REMOVED. THE SHAFT THEN STARTED TO COME THROUGH THE HUB ITSELF. THE TYPE OF PROCEDURE PERFORMED WAS A CORONARY ANGIOGRAM VIA RADIAL ACCESS. ADDITIONAL INFORMATION WAS RECEIVED ON 21AUG2024: ACCESS WAS FIRST ATTEMPTED WITH A 6 FRENCH GLIDESHEATH. RESISTANCE WAS FELT, THEREFORE, THEY SWITCHED TO THE 6 FRENCH GLIDESHEATH SLENDER INVOLVED. ROUGHLY TWO-THIRDS OF THE SHEATH WAS INSERTED, AND RESISTANCE WAS FELT AGAIN. A CORDIS 6 FRENCH JR4 WAS INSERTED INTO THE GLIDESHEATH SLENDER TO SUPPORT INSERTION OF THE REMAINING THIRD OF THE SHEATH. THE SHEATH WOULD NOT ADVANCE, AND THE CASE MOVED FORWARD AS PLANNED WITH A THIRD OF THE SHEATH OUTSIDE OF THE ARTERIOTOMY. THE CASE WAS COMPLETED WITH THIRD OF SHEATH OUTSIDE THE ARTERIOTOMY. THE SHEATH BECAME DETACHED FROM THE HUB WHEN THE JR4 WAS BEING REMOVED. THE SHEATH COULD BE SEEN EXITING THE HUB "AS IF IT HAD GRIPPED ON TO THE GUIDE CATHETER". THERE WAS NO BLOOD LOSS. THE PATIENT WAS STABLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE REPORTED EVENT DID NOT RESULT IN PATIENT INJURY AND/OR REQUIRE MEDICAL OR SURGICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20199925 ↗
• MalfunctionJun 21, 2024Leak/Splash; Obstruction of Flow; Leak/Splash; Obstruction of Flow

  THE USER FACILITY REPORTED THAT THE SHEATH WAS HARD TO ASPIRATE. THE DOCTOR ADVANCED THE SHEATH WITH THE DILATOR, THEN TRIED TO ASPIRATE THE SHEATH; HOWEVER, NOTHING CAME THROUGH THE SHEATH. THE CASE WAS COMPLETED SUCCESSFULLY, AND THE PATIENT LEFT THE ROOM IN STABLE CONDITION. NO BLOOD LOSS WAS REPORTED. THE PATIENT WAS NOT INJURED DURING THE EVENT AND MEDICAL/SURGICAL INTERVENTION WAS NOT NEEDED. THERE IS NO DIRECT CLAIM THAT THE REPORTED DEVICE CAUSED OR CONTRIBUTED TO A PATIENT INJURY OR THE NEED FOR MEDICAL INTERVENTION. ADDITIONAL INFORMATION WAS RECEIVED ON 05JUN2024: THE PROCEDURE PERFORMED WAS A LEFT BRACHIAL VEIN ACCESS FOR A LUE VENOGRAM AND LEFT SUBCLAVIAN PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). THE SHEATH WAS NOT ASPIRATING EVERY TIME. SOMETIMES IT WOULD ASPIRATE A LITTLE BIT AND THE DOCTOR COULD STILL INJECT CONTRAST THROUGH THE SHEATH FOR THE IMAGES. DURING THE CASE IT DID NOT 100% ASPIRATE CORRECTLY. THE ONLY THING IN THE SHEATH WAS THE CATHETER A FEW TIMES FOR THE INJECTION OF CONTRAST AND THE OTHER TIMES IT WAS JUST THE SHEATH ITSELF WHEN IT WAS HAVING A HARD TIME FLUSHING THROUGH. THE DOCTOR WOULD PUT THE DILATOR BACK IN TO MAKE SURE IT WAS OPENED ALL THE WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19583568 ↗
• MalfunctionMay 24, 2024Fracture; Fracture

  THE USER FACILITY REPORTED THAT POST THE LEFT HEART CATHETERIZATION, THE TECH NOTICED THAT THE TIP OF THE SHEATH LOOKED TO BE FRAYED. THERE WAS NO ISSUE WITH THE PATIENT AND THERE WAS NO BLOOD LOSS. ADDITIONAL INFORMATION WAS RECEIVED ON 26ARP2024: THERE WERE NO DIFFICULTIES WITH THE PROCEDURE. THEY REMOVED THE RADIAL SHEATH AND SAW FRACTURE AT THE END OF IT. ONLY DIFFERENCE IS THEY USED A ROC BAND WHICH WE ARE TRAILING, AND IT DID FLATTEN THE SHEATH AT REMOVAL AND NOTICED THE FRACTURE AT THE END OF THE SHEATH AFTER REMOVAL. THERE WAS NO BLOOD LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19391560 ↗
• MalfunctionMay 23, 2024

  PROCEDURE: ELECTIVE PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY. THE SIDEWALL ON THE SHEATH SPLIT AND THE WIRE WENT THROUGH. NO KNOWN HARM TO PATIENT, ANOTHER ONE USE. MANUFACTURER RESPONSE FOR INTRODUCER, CATHETER, GLIDESHEATH SLENDER (PER SITE REPORTER), WILL OBTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19380444 ↗
• MalfunctionApr 3, 2024

  ELDERLY MALE WITH HISTORY OF UNSTABLE ANGINA. PROCEDURE: HEART CATHETERIZATION. THE TIP IF THE SHEATH'S DILATOR IS CLOSED OFF. UNABLE TO USE ON PATIENT. ANOTHER DILATOR USED WITHOUT PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19031146 ↗
• MalfunctionMar 30, 2024Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THE INVOLVED GLIDESHEATH SLENDER DEVICE SHEATH VALUE LEAKED. BLOOD LOSS WAS LESS THAN 250 CC. LEAKAGE OCCURRED THREE TIMES DURING THE SAME PATIENT HEART CATH, AND THE LEAKAGE WAS DESCRIBED AS MINIMAL. THEY REPLACED EACH GSS WITH ANOTHER OF THE SAME LOT AND EACH TIME IT LEAKED AGAIN. THERE WAS NO HARM TO PATIENT WHO IS STABLE CONDITION. THE EVENT OCCURRED INTRA-OPERATIVE. THERE IS NOT A DIRECT ALLEGATION THAT THE REPORTED DEVICE CAUSED OR CONTRIBUTED TO PATIENT INJURY AND/OR NEED FOR MEDICAL INTERVENTION. THE PATIENT WAS NOT INJURED DURING THE EVENT AND MEDICAL/SURGICAL INTERVENTION WAS NOT NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19009058 ↗
• MalfunctionMar 20, 2024Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THE INVOLVED PRODUCT HAD GREATER THAN USUAL VALVE LEAKAGE AROUND THE CATHETER USED DURING A LEFT HEART CATHETERIZATION (LHC). ESTIMATED BLOOD LOSS WAS LESS THAN 250 CC.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18947112 ↗
• MalfunctionMar 12, 2024Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THE INVOLVED SHEATH WAS USED DURING A ROUTINE LEFT HEART CATHETERIZATION (LHC) CASE. THE PHYSICIAN REPORTED VALVE LEAKAGE AROUND THE CATHETER DURING THE CASE DESPITE TRYING TO CENTER. THE SPECIFIC CATHETER USED IN CONJUNCTION WAS NOT REPORTED. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC'S. THE EVENT OCCURRED INTRA-OPERATIVE. THE REPORTED EVENT DID NOT RESULT IN PATIENT INJURY AND/OR REQUIRED 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18887358 ↗
• MalfunctionFeb 11, 2024Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT DURING LEFT HEART CATHETERIZATION (LHC) VIA RIGHT RADIAL APPROACH (RRA) IT WAS NOTED THAT THE VALVE WAS LEAKING. THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. SHEATH SIZE USED WAS A 6FR. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC'S. THE PATIENT WAS NOT INJURED DURING THE EVENT AND MEDICAL/SURGICAL INTERVENTION WAS NOT NEEDED. 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 17 JAN 2024: PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18682750 ↗
• MalfunctionFeb 3, 2024Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT DURING THE ST-ELEVATION MYOCARDIAL INFARCTION (STEMI) PROCEDURE VIA RIGHT RADIAL ARTERY, IT WAS NOTICED THAT THE SHEATH WAS LEAKING FROM THE VALVE. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. ADDITIONAL INFORMATION WAS RECEIVED ON 11JAN2024: THE DEVICE DID NOT APPEAR TO BE DAMAGED. THE SHEATH WAS USED FOR THE ENTIRE PROCEDURE AND WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18637259 ↗
• MalfunctionJan 22, 2024

  ELDERLY FEMALE WITH CORONARY ARTERY DISEASE, AND RECENT CHEST DISCOMFORT, AND SHORTNESS OF BREATH. PROCEDURE: RIGHT HEART CATHETERIZATION. WHEN THE TERUMO GLIDESHEATH SLENDER 6 FR. REMOVED FROM PACKAGE, THERE WAS A LARGE BEND IN THE WIRE MIDWAY. NOT USED ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18551468 ↗
• MalfunctionNov 19, 2023Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT WHEN PERFORMING A HEART CATHETERIZATION, THE DOCTORS CLAIMED THAT THE INVOLVED GLIDESHEATH SLENDER DEVICE HEMOSTATIC VALVE WAS NOT WORKING PROPERLY AND THAT THERE HAS BEEN AN UNUSUAL AMOUNT OF BLEEDING OUT OF THE SHEATH. THIS HAS HAPPENED FOUR TIMES WITHIN A 24-HR. THE EVENT OCCURRED INTRA-OPERATIVE. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18166962 ↗