GLIDESHEATH SLENDER 50-1060Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00389701011332), received between Mar 23, 2017 and Apr 10, 2026 — classified as 10 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryApr 10, 2026Break; Unraveled Material

  TERUMO MEDICAL RECEIVED A USER FACILITY MEDWATCH REPORT # (B)(4). THE MEDWATCH EVENT DESCRIPTION STATED THAT: "PATIENT WAS BROUGHT TO CARDIAC CATH LAB FOR RADIAL APPROACH ANGIOGRAM. AFTER RADIAL ARTERY ACCESS THE WIRE WAS INSERTED AND THEN AN ATTEMPT WAS MADE TO REMOVE THE WIRE AND THE NEEDLE. IT WAS NOTICED THAT THE WIRE UNRAVELED AND APPROXIMATELY 1.5CM BROKE OFF IN THE PATIENT'S SKIN AND INTO THE RADIAL ARTERY. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? HEART CATHETERIZATION WITH POSSIBLE PCI. WHAT PROBLEM DID THE USER HAVE: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING); PREEXISTING CHARACTERISTICS THAT MAY HAVE CONTRIBUTED TO THE EVENT: CORONARY HEART DISEASE; DIABETES; HYPERTENSION." TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: THE BROKEN WIRE WAS RETRIEVED FROM THE PATIENT BY VASCULAR SURGERY. PALPABLE RADIAL PULSE POST-PROCEDURE WAS PERFORMED TO CONFIRM THE WIRE WAS RETRIEVED. THE WIRE BROKE DURING THE ATTEMPT OF THE REMOVAL OF WIRE AND NEEDLE. THE PATIENT WAS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 24845308 ↗
• MalfunctionFeb 25, 2026Material Frayed; Unraveled Material

  TERUMO RECEIVED THE FOLLOWING REPORTED INFORMATION: DURING A RADIAL CATHETER PROCEDURE, THE 6 FRENCH GLIDESHEATH SLENDER WIRE FRAYED IN THE PATIENT'S ARM; HOWEVER, THE WIRE DID NOT BREAK OFF INSIDE THE ARM AND DID NOT REQUIRE SURGICAL INTERVENTION. FLUOROSCOPY WAS PERFORMED TO ENSURE THE WIRE WAS REMOVED FROM THE PATIENT'S ARM. THE WIRE CAME OUT LIKE FINE HAIR, THEN CONTINUED TO UNRAVEL. THE SHEATH WAS USED; HOWEVER, A DIFFERENT NEEDLE AND WIRE WAS USED. THE PATIENT WAS STABLE; NO HARM WAS CAUSED. THE BLOOD LOSS WAS NEGLIGIBLE. THERE WAS NO DAMAGE NOTICED TO THE DEVICE PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24443281 ↗
• MalfunctionOct 29, 2025Unraveled Material; Unraveled Material

  TERUMO MEDICAL CORPORATION RECEIVED THE REPORTED INFORMATION. WHEN THE DOCTOR WAS GAINING ACCESS WITH THE GLIDESHEATH SLENDER AND WHILE MANIPULATING THE WIRE HE ATTEMPTED TO PULL IT OUT OF THE WIRE AND THE WIRE CAME UNRAVELED. THE WIRE WAS REMOVED AND THERE WAS NO PATIENT COMPLICATION. THERE WAS NO BLOOD LOSS. THE PROCEDURE BEING PERFORMED WAS RADIAL HEART CATHETERIZATION. ADDITIONAL INFORMATION WAS RECEIVED ON 13OCT2025: THERE WERE NO CONCOMITANT DEVICES USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23416412 ↗
• InjuryOct 29, 2025Material Separation; Unraveled Material; Material Separation; Unraveled Material

  TERUMO MEDICAL CORPORATION RECEIVED THE REPORTED INFORMATION. WHEN THE DOCTOR WAS GAINING ACCESS WITH THE GLIDESHEATH SLENDER AND WHILE MANIPULATING THE WIRE HE ATTEMPTED TO PULL IT OUT OF THE WIRE AND THE WIRE CAME UNRAVELED. THE WIRE WAS REMOVED AND THERE WAS NO PATIENT COMPLICATION. THERE WAS NO BLOOD LOSS. THE PROCEDURE BEING PERFORMED WAS RADIAL HEART CATHETERIZATION. ADDITIONAL INFORMATION WAS RECEIVED ON 13OCT2025: WHEN THE DOCTOR WAS GAINING ACCESS WITH THE DEVICE, HE ATTEMPTED TO REMOVE WIRE THROUGH THE NEEDLE. THE WIRE BECAME UNRAVELED, AND AT THAT TIME SEPARATED FROM THE WIRE. IT WAS NOT KNOWN AT THE TIME IF THE TIP OF THE WIRE WAS LEFT IN THE PATIENT. TWO DAYS LATER IN THE INTENSIVE CARE UNIT (ICU), THE PATIENT DEVELOPED A SORE AT THE ENTRY SITE. THE DOCTOR CLEANED THE SITE AND NOTICED THE WIRE PROTRUDING THROUGH SKIN AND WAS ABLE TO REMOVE THE WIRE. THE WIRE REMOVED WAS ABOUT 19MM. THE PATIENT WAS FINE AND HAD NO OTHER COMPLICATIONS.

  Patient problems: Foreign Body In Patient

  MAUDE report 23416411 ↗
• MalfunctionJun 9, 2025Material Separation; Positioning Problem; Material Separation; Positioning Problem

  THE USER FACILITY REPORTED THAT THE GLIDESHEATH WAS USED FOR A RADIAL CASE. WHEN THEY WENT TO PULL OUT THE WIRE, THE WIRE WAS SHEARED. THEY DID FLOURO THE PATIENT'S ARM TO MAKE SURE NOTHING WAS LEFT AND EVERYTHING WAS GOOD. THERE WAS NO BLOOD LOSS. THE REPORTED EVENT DID NOT RESULT IN PATIENT INJURY AND/OR REQUIRE MEDICAL OR SURGICAL INTERVENTION. ADDITIONAL INFORMATION WAS RECEIVED ON 23MAY2025: THE PROCEDURE PERFORMED FOR THE PATIENT WAS HEART CATH. A 6 FRENCH GLIDE SLENDER WAS THE PROCEDURE SHEATH SIZE USED. THERE WERE DIFFICULTIES WITH ARTERIAL ACCESS, SHEATH, GUIDEWIRE, OR CATHETER INSERTION. THE DOCTOR HAD A HARD TIME ADVANCING THE WIRE THROUGH THE NEEDLE, HE REMOVED THE WIRE THROUGH THE NEEDLE AND THE WIRE TIP CAME APART. THE ARM WAS SCANNED WITH FLOURO AND NO REMNANTS WERE FOUND TO BE LEFT BEHIND. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22169291 ↗
• MalfunctionApr 12, 2024Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THE VALVE OF THE INVOLVED GLIDESHEATH SLENDER WAS LEAKING THE ENTIRE CASE DURING A LEFT HEART CATH AND INTERVENTION. THE EVENT OCCURRED INTRA-OPERATIVE. THE BLOOD LOSS WAS LESS THAN 250CC'S. THE REPORTED EVENT DID NOT RESULT IN PATIENT INJURY AND/OR REQUIRE MEDICAL INTERVENTION OR SURGICAL INTERVENTION. THERE IS A DIRECT ALLEGATION THAT THE REPORTED DEVICE CAUSED OR CONTRIBUTED TO PATIENT INJURY AND/OR NEED FOR MEDICAL INTERVENTION. ADDITIONAL INFORMATION WAS RECEIVED ON 07 MAR 2024: NO SHEATHS WERE EXCHANGED DURING THE PROCEDURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19096710 ↗
• MalfunctionMar 28, 2024Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT DURING A ROUTINE LEFT HEART CATHETERIZATION, THE HEMOSTATIC VALVE LEAKED WITH A WIRE AND CATHETER INSERTED. THE PATIENT WAS IN STABLE CONDITION. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC'S. THE REPORTED EVENT DID NOT RESULT IN PATIENT INJURY AND/OR 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 07 MAR 2024: NO SHEATHS WERE EXCHANGED DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18991634 ↗
• InjuryDec 30, 2022Break; Break

  TERUMO MEDICAL RECEIVED A USER FACILITY MEDWATCH REPORT # 4600040000-2022-8015. THE EVENT DESCRIPTION STATES: DOCTOR WAS ATTEMPTING TO OBTAIN RIGHT RADIAL ACCESS, HE HAD DIFFICULTY ADVANCING THE MICROWIRE AND WAS REMOVING IT WHEN THE WIRE UNRAVELED AND BROKE OFF IN RIGHT RADIAL ARTERY. TWO OTHER DOCTORS CALLED FOR ASSISTANCE. THE SECOND DOCTOR ATTEMPTED TO SNARE THE WIRE, HOWEVER, WAS UNSUCCESSFUL. THE PATIENT WAS THEN ADDED TO THE THIRD DOCTORS SURGICAL SCHEDULE FOR SURGICAL WIRE REMOVAL. NO VARIANCE FROM TYPICAL WORKFLOW AND OR STANDARD OF CARE NOTED. DESCRIPTION OF THE THIRD DOCTOR'S PROCEDURE: THE PATIENT WAS BROUGHT TO THE OPERATING ROOM AND LAID SUPINE ON THE TABLE. AFTER MONITORED ANESTHESIA CARE WAS ADMINISTERED, THE RIGHT UPPER EXTREMITY WAS THEN PREPPED AND DRAPED IN STANDARD SURGICAL FASHION. THE PATIENT WAS GIVEN ANTIBIOTICS PRIOR TO INCISION. USING FLUOROSCOPY, THE RIGHT WRIST WAS IMAGED IN THE WIRE WAS IDENTIFIED WITHIN THE DISTAL LEFT FOREARM REGION. A SMALL LONGITUDINAL INCISION WAS MADE OVERLYING THE RADIAL ARTERY AT THIS SITE AFTER INJECTING 0.5% MARCAINE WITH EPINEPHRINE. DISSECTION WAS CARRIED DOWN THROUGH THE SUBCUTANEOUS TISSUE WITH THE BOVIE CAUTERY. THE FASC

  Patient problems: Foreign Body In Patient

  MAUDE report 16076399 ↗
• MalfunctionDec 29, 2021Incomplete or Missing Packaging; Incomplete or Missing Packaging

  IT WAS REPORTED THAT THERE WAS NO DIRECT ALLEGATION AGAINST THE DEVICE.

  Patient problems: Needle Stick/Puncture

  MAUDE report 13112897 ↗
• MalfunctionSep 3, 2021Fracture; Fracture

  THE USER FACILITY REPORTED THAT DURING A LEFT LEG VENOGRAM WITH ACCESS FROM THE LEFT TIBIAL VEIN, A 6X100 BSC MUSTANG BALLOON WAS BEING WITHDRAWN DEFLATED WHEN THE SHEATH INVERTED ITSELF AND CAME OUT THROUGH THE SHEATH HUB. PRESSURE WAS HELD FOR HEMOSTASIS. ADDITIONAL INFORMATION WAS RECEIVED ON 13AUG2021. THERE WERE NO ISSUES WITH INSERTION OF THE GLIDESHEATH (GS) OR TORTUOUS ANATOMY. THE PATIENT WAS IN STABLE CONDITION. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12419151 ↗
• MalfunctionJan 22, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE USER FACILITY THAT THE GLIDESHEATH SLENDER SHEATH THAT WAS LEAKING ONLY WHEN A CATHETER WAS INSERTED THRU THE SHEATH. DURING THE PROCEDURE THE DOCTOR HAD TO SWITCH TO FEMORAL ACCESS DUE TO DIFFICULT ANATOMY INDEPENDENT OF THE RADIAL ACCESS. THE PROCEDURE WAS COMPLETED, AND THE PATIENT WAS FINE. ADDITIONAL INFORMATION WAS RECEIVED ON 05JAN2021. THE PROCEDURE PERFORMED WAS A DIAGNOSTIC CATHETERIZATION. THE LEAK OCCURRED AT THE VALVE WHEN THE CATHETER WAS ACROSS THE VALVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11217523 ↗
• InjuryDec 16, 2020Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE INVOLVED GLIDESHEATH SLENDER WAS USED, AND THE WIRE IN THE NITINOL RADIAL KIT WAS INSERTED INTO THE RADIAL ARTERY. IT WAS SUSPECTED THE WIRE ENTERED A SIDE BRANCH OF THE RADIAL ARTERY AND THE WIRE UNCOILED AND BROKE AS IT WAS ATTEMPTED TO BE PULLED BACK INTO THE NEEDLE. THE DISTAL PORTION OF THE WIRE WAS LEFT IN THE PATIENT. THEY GAINED FEMORAL ACCESS TO CONTINUE WITH THE CARDIAC CATHETERIZATION. VASCULAR SURGERY WAS TO BE CONSULTED AFTER THE CASE FOR REMOVAL OF THE DISTAL PORTION OF THE WIRE. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE PROCEDURE WAS COMPLETED. ADDITIONAL INFORMATION WAS RECEIVED ON 02DEC2020. VASCULAR WAS CONSULTED AND IT WAS DECIDED TO LEAVE THE WIRE.

  Patient problems: Foreign Body In Patient

  MAUDE report 11018506 ↗
• MalfunctionJun 15, 2020Material Deformation; Material Deformation

  THIS REPORT HAS BEEN DEEMED REPORTABLE UPON INVESTIGATION OF THE ACTUAL DEVICE. THE USER FACILITY REPORTED THAT THE GLIDESHEATH SLENDER WAS USED DURING THE ANGIOGRAM PROCEDURE, AND THE SHEATH MALFUNCTIONED. THE PATIENT'S CONDITION WAS STABLE, AND THE ANGIOGRAM WAS SUCCESSFUL. THE BLOOD LOSS WAS LESS THAN 250CC'S. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 28JUN2019. THEY UTILIZED THE GUIDEWIRE; THE SHEATH WAS BEING PLACED OVER THE WIRE AND IT KINKED AND WAS UNABLE TO BE UTILIZED FOR ACCESS. THE PUNCTURE SITE WAS LEFT DORSALIS PEDIS ARTERY, RETROGRADE. LESION TREATMENT HISTORY WAS REPORTED TO BE LEFT ANTERIOR TRIBAL OCCLUDED, LEFT POSTERIOR TRIAL OCCLUDED, LEFT PERONEAL ARTERY PATENT.

  Patient problems: Blood Loss

  MAUDE report 10153673 ↗
• InjuryApr 19, 2019Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT A GLIDESHEATH NITINOL WIRE WAS ADVANCED THROUGH THE NEEDLE, AND THEN THE DOCTOR REMOVED THE WIRE. THE WIRE WAS BADLY FRAYED. THE DOCTOR GAINED ACCESS DURING A RADIAL PROCEDURE. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. ADDITIONAL INFORMATION WAS RECEIVED ON APRIL 18, 2019. THE PATIENT WAS IN STABLE CONDITION. THEY SWITCHED TO FEMORAL ACCESS AND COMPLETED THE LEFT HEART CATHETERIZATION (LHC). NO INTERVENTION WAS NECESSARY. PART OF THE WIRE WAS LEFT IN THE PATIENT AND WAS REPORTED TO STILL BE THERE.

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

  MAUDE report 8531963 ↗
• InjuryApr 10, 2019Difficult to Insert; Difficult to Insert

  THE USER FACILITY REPORTED THAT THE NITINOL WIRE INCLUDED IN THE GLIDESHEATH SLENDER KIT WOULD NOT PASS THROUGH THE ACCESS NEEDLE DURING ARTERIAL ACCESS. A SECOND AND THIRD KIT WERE OPENED FOR THE WIRE BUT NEITHER OF THEM WOULD PASS THROUGH THE SLENDER ACCESS NEEDLE. A COOK PEDIATRIC MICRO ACCESS KIT WAS OPENED AND THEN USED THROUGH THE NEEDLE FROM THE GLIDESHEATH SLENDER KIT TO SUCCESSFULLY DELIVER THE SHEATH. THE PATIENT CONDITION WAS REPORTED TO BE STABLE. THE PROCEDURE OUTCOME WAS SUCCESSFUL. BLOOD LOSS WAS LESS THAN 250CC. ADDITIONAL INFORMATION WAS RECEIVED ON MARCH 29, 2019. THE PROCEDURE WAS A DIAGNOSTIC CORONARY CASE FROM THE RIGHT RADIAL ARTERY.

  Patient problems: Blood Loss

  MAUDE report 8499519 ↗
• InjuryApr 10, 2019Difficult to Insert; Difficult to Insert

  THE USER FACILITY REPORTED THAT THE NITINOL WIRE INCLUDED IN THE GLIDESHEATH SLENDER KIT WOULD NOT PASS THROUGH THE ACCESS NEEDLE DURING ARTERIAL ACCESS. A COOK MICRO ACCESS WIRE WAS THEN USED THROUGH THE NEEDLE FROM THE GLIDESHEATH SLENDER KIT TO SUCCESSFULLY DELIVER THE SHEATH. THE PATIENT CONDITION WAS REPORTED TO BE STABLE. THE PROCEDURE OUTCOME WAS SUCCESSFUL. BLOOD LOSS WAS LESS THAN 250CC. ADDITIONAL INFORMATION WAS RECEIVED ON MARCH 29, 2019. THE PROCEDURE WAS A DIAGNOSTIC CORONARY CASE FROM THE RIGHT RADIAL ARTERY.

  Patient problems: Blood Loss

  MAUDE report 8499518 ↗
• InjuryApr 10, 2019Difficult to Insert; Difficult to Insert

  THE USER FACILITY REPORTED THAT THE NITINOL WIRE INCLUDED IN THE GLIDESHEATH SLENDER KIT WOULD NOT PASS THROUGH THE ACCESS NEEDLE DURING ARTERIAL ACCESS. A SECOND AND THIRD KIT WERE OPENED FOR THE WIRE BUT NEITHER OF THEM WOULD PASS THROUGH THE SLENDER ACCESS NEEDLE. A COOK PEDIATRIC MICRO ACCESS KIT WAS OPENED AND THEN USED THROUGH THE NEEDLE FROM THE GLIDESHEATH SLENDER KIT TO SUCCESSFULLY DELIVER THE SHEATH. THE PATIENT CONDITION WAS REPORTED TO BE STABLE. THE PROCEDURE OUTCOME WAS SUCCESSFUL. BLOOD LOSS WAS LESS THAN 250CC. ADDITIONAL INFORMATION WAS RECEIVED ON MARCH 29, 2019. THE PROCEDURE WAS A DIAGNOSTIC CORONARY CASE FROM THE RIGHT RADIAL ARTERY.

  Patient problems: Blood Loss

  MAUDE report 8499517 ↗
• InjuryApr 10, 2019Difficult to Insert; Difficult to Insert

  THE USER FACILITY REPORTED THAT THE NITINOL WIRE INCLUDED IN THE GLIDESHEATH SLENDER KIT WOULD NOT PASS THROUGH THE ACCESS NEEDLE DURING ARTERIAL ACCESS. A SECOND AND THIRD KIT WERE OPENED FOR THE WIRE BUT NEITHER OF THEM WOULD PASS THROUGH THE SLENDER ACCESS NEEDLE. A COOK PEDIATRIC MICRO ACCESS KIT WAS OPENED AND THEN USED THROUGH THE NEEDLE FROM THE GLIDESHEATH SLENDER KIT TO SUCCESSFULLY DELIVER THE SHEATH. THE PATIENT CONDITION WAS REPORTED TO BE STABLE. THE PROCEDURE OUTCOME WAS SUCCESSFUL. BLOOD LOSS WAS LESS THAN 250 CC. ADDITIONAL INFORMATION WAS RECEIVED ON MARCH 29, 2019. THE PROCEDURE WAS A DIAGNOSTIC CORONARY CASE FROM THE RIGHT RADIAL ARTERY.

  Patient problems: Blood Loss

  MAUDE report 8499516 ↗
• MalfunctionFeb 12, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE USER FACILITY REPORTED THAT THE DOCTOR FELT SOME RESISTANCE WITH THE GLIDESHEATH SLENDER AS THE WIRE WAS PUT IN THE NEEDLE. THE WIRE PASSED A LITTLE FURTHER AND THEN WOULD NOT ADVANCE. THE DOCTOR LOOKED UNDER FLUORO AND ELECTED TO REMOVE THE WIRE INSTEAD OF PUSHING IT ANY MORE. AS THE DOCTOR PULLED BACK, THE DOCTOR NOTICED THAT THE FRONT OF THE WIRE WAS NOT MOVING THE SAME AMOUNT AS THE BACK OF THE WIRE. THE IMAGE ON THE FLUORO SHOWED THE DISTAL TIP OF THE WIRE WAS THINNER AND LONGER THAN IT WAS ORIGINALLY. THE DOCTOR REMOVED THE NEEDLE AND WIRE TOGETHER. THE PATIENT HAD NO ISSUES. THE HEART CATHETERIZATION WAS PERFORMED FROM ALTERNATE ACCESS SITE. THE PATIENT WAS UNAFFECTED BY THE PRODUCT ISSUE AND WAS IN STABLE CONDITION. THE PATIENT WAS DISCHARGED. THE LEFT HEART CATHETERIZATION PROCEDURE WAS SUCCESSFUL. THERE WERE NO OTHER DEVICES OR EQUIPMENT USED WITH THE PRODUCT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8332062 ↗
• MalfunctionAug 13, 2018Break; Break

  THE USER FACILITY REPORTED THAT THE WIRE (THAT COMES WITH THE SHEATH) STARTED TO UNRAVEL WHEN THE PHYSICIAN WAS TORQUEING IT IN THE RADIAL ARTERY. THE WIRE WAS REMOVED AND THERE WAS NO INJURY TO PATIENT. THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION. THE PROCEDURE OUTCOME WAS GOOD. IT IS UNKNOWN IF ANY OTHER DEVICES OR EQUIPMENT WAS USED WITH THE GLIDESHEATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7777586 ↗
• InjuryJul 12, 2018Break; Break

  THE USER FACILITY REPORTED THAT WHILE ACCESSING THE RADIAL ARTERY THE WIRE BECAME UNRAVELED WHEN USING THE GLIDESHEATH. WIRE WAS EXTRACTED VIA SURGERY. INTRA-ARTERIAL ACCESS WAS NOT REQUIRED. THE PATIENT IS IN STABLE CONDITION. THE PROCEDURE WAS ABORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 7/10/2018. THE WIRE WAS BROKEN IN THE RADIAL ARTERY. THE WIRE WAS SURGICALLY REMOVED. THE PATIENT WAS HAVING A LEFT HEART CATHETERIZATION (LHC) PROCEDURE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7681465 ↗
• MalfunctionMar 23, 2017Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED VALVE LEAKAGE DURING A PROCEDURE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: A BACKFLOW OF BLOOD WAS REPORTED COMING OUT OF THE VALVE FROM THE SIDE PORT AFTER IT IS FLUSHED OUT; BLOOD LOSS WAS LESS THAN 250 CC; THE PROCEDURE WAS COMPLETED AND THE OUTCOME WAS REPORTED AS GOOD; THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REQUIRED, PATIENT IS STABLE; AND TWO OTHER DEVICES WERE USED IN THIS SAME EVENT AND WERE ALSO REPORTED TO LEAK, SEE MDR NUMBERS 1118880-2017-00013 AND 1118880-2017-00015.

  Patient problems: Blood Loss

  MAUDE report 6428047 ↗
• MalfunctionMar 23, 2017Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED VALVE LEAKAGE DURING A PROCEDURE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: A BACKFLOW OF BLOOD WAS REPORTED COMING OUT OF THE VALVE FROM THE SIDE PORT AFTER IT IS FLUSHED OUT; BLOOD LOSS WAS LESS THAN 250CC; THE PROCEDURE WAS COMPLETED AND THE OUTCOME WAS REPORTED AS GOOD; THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REQUIRED, PATIENT IS STABLE; AND TWO OTHER DEVICES WERE USED IN THIS SAME EVENT AND WERE ALSO REPORTED TO LEAK, SEE MDR NUMBERS 1118880-2017-00013 AND 1118880-2017-00014.

  Patient problems: Blood Loss

  MAUDE report 6428043 ↗
• MalfunctionMar 23, 2017Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED VALVE LEAKAGE DURING A PROCEDURE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: A BACKFLOW OF BLOOD WAS REPORTED COMING OUT OF THE VALVE FROM THE SIDE PORT AFTER IT IS FLUSHED OUT; BLOOD LOSS WAS LESS THAN 250 CC; THE PROCEDURE WAS COMPLETED AND THE OUTCOME WAS REPORTED AS GOOD; THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REQUIRED, PATIENT IS STABLE; AND TWO OTHER DEVICES WERE USED IN THIS SAME EVENT AND WERE ALSO REPORTED TO LEAK, SEE MDR NUMBERS 1118880-2017-00014 AND 1118880-2017-00015.

  Patient problems: Blood Loss

  MAUDE report 6428042 ↗