GLIDESHEATH SLENDER 50-1050Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00389701011363), received between Feb 21, 2018 and Aug 13, 2026 — classified as 10 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50243745 ↗
• MalfunctionFeb 24, 2026Unraveled Material

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: IT WAS REPORTED THAT WHILE USING A 5FR GLIDESHEATH AT THE BEGINNING OF THE CASE, THE ACCESS WIRE FRAYED AT THE END DURING A BRACHIAL RIGHT HEART CATHETERIZATION PROCEDURE. THE WAS NO ISSUE WITH THE SHEATH. WIRE WAS IN THE BRACHIAL VEIN. THE ISSUE WAS NOTED IMMEDIATELY UNDER X-RAY; THEY COULD SEE THE WIRE UNRAVEL. THE PATIENT REMAINED FINE AND THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24438674 ↗
• InjuryOct 25, 2024Break; Break

  TERUMO MEDICAL RECEIVED AN FDA MEDWATCH REPORT # (B)(4). THE EVENT DESCRIPTION STATES: "ACCESS WIRE STUCK IN THE DISTAL TIP OF THE NEEDLE WHICH WAS LEFT INSIDE OF THE BODY. DISTAL TIP OF THE WIRE WAS STUCK IN THE ACCESS NEEDLE. UPON REMOVAL, THE WIRE HAD UNRAVELED WITHIN THE BODY OUTSIDE OF THE NEEDLE. IR DOCTOR CAME IN AND TRIED TO RETRIEVE IT. ALL DOCTORS DECIDED TO LEAVE IT IN THE BODY AFTER PERFORMING AN SVC ANGIOGRAM. TERUMO GLIDESHEATH SLENDER FR. 5. THE INTENDED PROCEDURE WAS CARDIAC CATH LAB PROCEDURE."

  Patient problems: Foreign Body In Patient

  MAUDE report 20534440 ↗
• InjuryOct 3, 2024Break; Break

  THE USER FACILITY REPORTED THAT THE GLIDESHEATH SLENDER DEVICE WAS USED IN A RIGHT HEART CATHETERIZATION (RHC). THE PATIENT HAD BRACHIAL VEIN ACCESS WITH AN ANGIOCATH IV CANNULA. THE IV CANNULA WAS TYPICALLY EXCHANGED OVER THE WIRE THAT COMES IN THE GLIDESHEATH SLENDER (GSS) KIT. NORMAL PREP PERFORMED OF SHEATH. IT WAS NOTED THAT THE DOCTOR FELT RESISTANCE UPON ADVANCING THE WIRE THROUGH THE IV CANNULA ACCESS. SEVERAL ATTEMPTS WERE MADE TO ADVANCE THE WIRE, AND THE WIRE TIP KEPT "BALLING UP", WHILE VISUALIZED UNDER FLUORO. DURING AN ATTEMPT THE DOCTOR EXPERIENCED THIS SCENARIO REPEAT AND UPON REMOVING THE WIRE REALIZED THAT A PORTION HAD BROKEN OFF AND WAS LEFT IN THE BRACHIAL VEIN. VASCULAR SURGERY WAS CONSULTED TO REMOVE THE PIECE LEFT BEHIND. ADDITIONAL INFORMATION WAS RECEIVED ON 09SEPT2024: THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THE PATIENT WAS STABLE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 20360878 ↗
• InjuryOct 3, 2024Break; Break

  TERUMO MEDICAL RECEIVED AN FDA MEDWATCH REPORT # MW5158312. THE EVENT DESCRIPTION STATES: "CEREBRAL ANGIO AND SMATXI VIA RIGHT RADIAL APPROACH DONE. PIECE OF WIRE WAS RETAINED DURING THE PROCEDURE. ATTEMPTS MADE TO FISH OUT SOME OF THE WIRE PIECE BY MAKING THE NICK LARGER AND SOME WAS RETRIEVED BUT NOT ALL. FLUORO IMAGE SHOWS THE WIRE REMNANT APPEARS TO BE EXTRA-ARTERIAL COMPARED TO INDWELLING SHEATH. VASCULAR SURGERY CONSULTED FOR RETAINED WIRE AT RIGHT RADIAL ACCESS SITE. DUPLEX SCAN: THE RIGHT RADIAL ARTERY APPEARS TO BE OCCLUDED. THERE APPEARS TO BE A SHADOW NOTED IN THE DISTAL FOREARM THAT IS POSSIBLY INTRA-ARTERIAL IN THE RADIAL ARTERY OF THE RIGHT UPPER EXTREMITY. ON (B)(6) 2024: TO OPERATING ROOM FOR RIGHT RADIAL CUTDOWN, REMOVAL OF RETAINED WIRE."

  Patient problems: Obstruction/Occlusion

  MAUDE report 20360721 ↗
• InjuryJul 18, 2024Fracture; Fracture

  THE USER FACILITY REPORTED THAT TWO ACCESS SITES WERE CREATED IN THE SAME RADIAL ARTERY. THE FIRST ACCESS SITE WAS SMALL, AND THEY WERE UNSURE IF THEY WERE IN THE VESSEL. THE SECOND ACCESS SITE WAS IN THE SAME ARTERY WAS CREATED TO VERIFY. A 014 WIRE THROUGH AND A 035 CATHETER BALLOON WAS USED, THEY TOOK PICS OF RT/LT. THEY PULLED THE FIRST SHEATH, AND THEN PULLED SECOND SHEATH RETRIEVED WITH A BALLOON. ADDITIONAL INFORMATION WAS RECEIVED ON 26JUN2024: THE PHYSICIAN GAINED ACCESS WITH TWO SHEATHS IN THE SAME RADIAL ARTERY. THIS SHEATH WAS THE SECOND SHEATH PLACED, WHICH SHEARED DURING THE PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED ON 27JUN2024: THE PROCEDURE WAS COMPLETED USING THE SHEATH. THE PATIENT WAS STABLE. THE SHEATH SHEARED INSIDE THE PATIENT AND A BALLOON WAS USED TO RETRIEVE.

  Patient problems: Foreign Body In Patient

  MAUDE report 19780116 ↗
• InjurySep 21, 2023Break; Break

  THE USER FACILITY REPORTED THAT WHILE USING THE SHEATH IN THE LEFT POPLITEAL ARTERY. IT WAS REPORTED THAT THE DOCTOR HAD THE PATIENT BEND THE KNEE AT SOME POINT DURING THE PROCEDURE. AT THE END OF THE CASE, THEY REALIZED THE SHEATH SEPARATED FROM THE HUB WHICH REQUIRED THE DOCTOR TO SNARE IT OUT. THERE WAS NO REPORTED BLOOD LOSS. THERE IS NO DIRECT ALLEGATION THAT THE REPORTED DEVICE CAUSED OR CONTRIBUTED TO PATIENT INJURY AND/OR NEED FOR MEDICAL INTERVENTION. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2023: THE DEVICE DID NOT APPEAR TO BE DAMAGED PRIOR TO USE. THE TYPE OF PROCEDURE THAT WAS BEING PERFORMED ON THE PATIENT PRIOR TO USING THE GLIDESHEATH SLENDER WAS A LOWER EXTREMITY VENOGRAM AND STENT PLACEMENT. THE PATIENT WAS STABLE. THE PROCEDURE WAS SUCCESSFUL. THERE WAS NO TESTING PERFORMED TO CONFIRM THAT THE PIECE WAS REMOVED ENTIRELY. IT IS UNKNOWN IF THERE WERE ANY CONCOMITANT DEVICES USED WITH THE GLIDESHEATH.

  Patient problems: Foreign Body In Patient

  MAUDE report 17795869 ↗
• MalfunctionJun 14, 2023Break; Break

  THE USER FACILITY REPORTED THAT THE OPERATOR GAINED ACCESS WITH THE NEEDLE IN THE GLIDESHEATH SLENDER KIT. HE INSERTED THE WIRE THROUGH THE NEEDLE. HE STATED THAT IT DID NOT FEEL CORRECT WHEN INSERTING THE WIRE. HE PULLED BACK ON THE WIRE AND NOTICED THE WIRE HAD BECOME UNRAVELED. HE THEN PULLED THE WIRE AND SHEATH TOGETHER OUT OF THE PATIENT'S BODY AND HELD PRESSURE AT THE PUNCTURE SITE. UPON REMOVAL, HE NOTICED THAT THE WIRE WAS LONGER AND UNRAVELED AT THE DISTAL TIP. THE PATIENT WAS IN STABLE CONDITION. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THE PROCEDURE OUTCOME WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED ON 10MAY2023: THE PROCEDURE TAKING PLACE WAS A DIAGNOSTIC LEFT HEART CATHETERIZATION. THEY CONTINUED THE CASE BY OPENING ANOTHER PACKAGE AND PROCEEDED WITH CASE. THEY RAN THE WIRE THROUGH THE NEEDLE PROVIDED IN OUR GLIDESHEATH SLENDER NITINOL KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17124968 ↗
• InjuryApr 22, 2023Break; Break

  THE USER FACILITY REPORTED THAT THEY HAD A LEFT PEDAL ACCESS CASE WITH A GLIDESHEATH SLENDER. ATHERECTOMY AND PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) OF LEFT AT/POP PERFORMED. UPON REMOVING THE JADE BALLOON, THEY NOTED THE SHEATH BROKE BELOW HUB AT THE SHAFT. THE ENTIRE SHEATH AND BALLOON/GUIDEWIRE REMOVED, AND MANUAL PRESSURE APPLIED. THEY WERE UNABLE TO PERFORM FINAL ANGIOGRAM. THE PATIENT WAS STABLE AND HAS BEEN DISCHARGED HOME. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16792730 ↗
• MalfunctionMar 17, 2023Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE USER FACILITY REPORTED THAT THE 5 FRENCH PEDAL SHEATH (50-1050) BROKE AT THE HUB WHEN ATTEMPTING TO REMOVE THE BALLOON (6X150 EV3) VIA LEFT PEDAL ACCESS SITE. THE DOCTOR STATED THE POSSIBLY OF THE BALLOON RE-WRAP MAY HAVE NOT BEEN GREAT, AND HE BELIEVED IT CAUSED SOME SORT OF SUCTION ON THE SHEATH SHAFT ITSELF CAUSING SHEATH BREAKAGE. WHEN REMOVING THE BALLOON, THE DOCTOR ENCOUNTERED SOME RESISTANCE AND WHEN BALLOON CAME OUT SO DID THE SHAFT OF THE SHEATH (ATTACHED TO BALLOON). ONLY THE GLIDEWIRE ADVANTAGE, SHEATH HUB, AND SMALL PORTION OF THE SHEATH REMAINED. ALL PIECES WERE REMOVED, AND PRESSURE WAS HELD AT THE SITE FOR HEMOSTASIS. THE DOCTOR FELT ALL SHEATH COMPONENTS WERE REMOVED FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETE, AND THE DOCTOR WAS PENDING A FINAL ANGIOGRAM THAT COULD NOT BE DONE SINCE ACCESS WAS LOST AT THIS POINT. THE BLOOD LOSS WAS LESS THAN 250CC'S. THE PROCEDURE WAS SUCCESSFUL. THE PATIENT WAS IN STABLE CONDITION AND DISCHARGED HOME. THERE WAS NO PATIENT INJURY OR SURGICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16566905 ↗
• InjuryDec 29, 2021Break; Break

  THE USER FACILITY REPORTED THAT A NEURO PROCEDURE, DIAGNOSTIC CEREBRAL, WAS PERFORMED VIA A GLIDE-SHEATH SLENDER. THE PHYSICIAN HAD RADIAL ACCESS AND ADVANCED THE WIRE WITHIN THE NEEDLE WHICH COMES IN THE KIT. THE PHYSICIAN TRIED TO WITHDRAW THE NEEDLE AND PART OF WIRE CAME OUT WITH THE NEEDLE. THE BRITE NITINOL TIP OF THE WIRE STAYED INSIDE THE ARM. THE PHYSICIAN ABANDONED RADIAL ACCESS AND USED COOK MICRO PUNCTURE SET VIA FEMORAL. THE PATIENT HAD RETAINED FOREIGN BODY WHICH RESULTED IN SURGERY CUT DOWN TO REMOVE FBV. THE PATIENT CONDITION AND PROCEDURE OUTCOME ARE UNKNOWN. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2021: WIRE WAS SUCCESSFULLY REMOVED DURING SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 13112880 ↗
• InjuryJan 22, 2021Break; Break

  TERUMO MEDICAL RECEIVED A USER FACILITY MEDWATCH REPORT # (B)(4). THE EVENT DESCRIPTION STATES: "THE PRODUCT WAS A GLIDE SHEATH SLENDER SIZE FRENCH AND APPARENTLY AS DOCTOR HAD ALREADY INSERTED THE SHEATH INTO THE PATIENT'S LEFT WRIST AND I GUESS AS IT WAS COMING OUT THE PIECE CAME APART, IT ACTUALLY BROKE APART SO WE HAD TO PULL IT FROM THE STERILE FIELD AND WE WERE NOT ABLE TO REUSE IT, WHICH WE TYPICALLY SHOULD HAVE BEEN ABLE TO. THE ORIGINAL INTENDED PROCEDURE WAS A THORACIC BRANCH SELECTIVE CATHETER PLACEMENT, ARTERIAL SYSTEM; EACH FIRST ORDER, WITHIN A VASCULAR FAMILY [36215 (CPT)], LEFT SUBCLAVIAN, TRANSCATHETER PLACEMENT OF AN INTRAVASCULAR STENT(S), PERCUTANEOUS; INITIAL VESSEL [37236 (CPT)], LEFT." ADDITIONAL INFORMATION WAS RECEIVED ON 04JAN2021. UPON REMOVAL THE PIECE OF THE DEVICE CAME APART. A STERILE FIELD IS AN AREA CREATED BY PLACING STERILE SURGICAL DRAPES AROUND THE PATIENT'S SURGICAL SITE AND ON THE STAND THAT WILL HOLD STERILE INSTRUMENTS AND OTHER ITEMS NEEDED DURING SURGERY. IT IS UNKNOWN WHAT PART OF THE DEVICE BROKE. THERE WERE NO BROKEN PIECES LEFT IN THE PATIENT. IT IS UNKNOWN IF ANY TEST WERE RAN TO CONFIRM TO ENSURE NO BROKEN PIECES WERE LEFT IN THE PAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11217586 ↗
• MalfunctionDec 24, 2020Break

  THE PRODUCT WAS A GLIDE SHEATH SLENDER SIZE FRENCH AND APPARENTLY AS DOCTOR HAD ALREADY INSERTED THE SHEATH INTO THE PATIENT'S LEFT WRIST, AND I GUESS AS IT WAS COMING OUT THE PIECE CAME APART, IT ACTUALLY BROKE APART SO WE HAD TO PULL IT FROM THE STERILE FIELD AND WE WERE NOT ABLE TO REUSE IT, WHICH WE TYPICALLY SHOULD HAVE BEEN ABLE TO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11071882 ↗
• MalfunctionNov 20, 2020Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT DURING UPON REMOVING THE GLIDESHEATH SLENDER DEVICE FROM THE PACKAGE, THE PHYSICIAN NOTED THAT IT WAS "KINKED", AND DISPOSED OF THE DEVICE IN ORDER TO MAINTAIN PATIENT SAFETY. THE DEVICE WAS NEVER USED ON THE PATIENT. THE DEVICE WAS REPLACED WITH A NEW GLIDESHEATH SLENDER WITH NO FURTHER ISSUES. PATIENT RADIAL ARTERY MEASURED 2.1MM, BI VARIANT VESSEL ANATOMY NOTED AT THE ACCESS SITE. PATIENT WAS IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS SUCCESSFUL. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10876760 ↗
• InjuryMay 21, 2020Break; Break

  A MAUDE DATABASE SEARCH CONDUCTED ON 27APRIL2020 FOUND A MAUDE REPORT NUMBER # (B)(4). THE EVENT DESCRIPTION STATES: "THE MD PASSED THE NITINOL GUIDE WIRE OVER THE NEEDLE INTO THE PATIENT'S RADIAL ARTERY. WHEN THE MD PULLED THE GUIDE WIRE OUT, THE PROXIMAL HEAD OF THE WIRE DETACHED, LEAVING BEHIND SOME WIRE AND AN INNER STRING INSIDE THE PATIENT'S WRIST. THE FRAGMENT WAS RETRIEVED AND REMOVED. NO HARM TO PATIENT." TERUMO MEDICAL RECEIVED AN FDA MEDWATCH (B)(4) WITH ADDITIONAL INFORMATION ON 28APRIL2020. THE EVENT DESCRIPTION STATES: "THE MD PASSED THE NITINOL GUIDE WIRE OVER THE NEEDLE INTO THE PATIENT'S RADIAL ARTERY. WHEN THE MD PULLED THE GUIDE WIRE OUT, THE PROXIMAL HEAD OF THE WIRE DETACHED, LEAVING BEHIND SOME WIRE AND AN INNER STRING INSIDE THE PATIENT'S WRIST. THE FRAGMENT WAS RETRIEVED AND REMOVED. NO HARM TO PATIENT."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10078442 ↗
• MalfunctionMar 2, 2020Material Puncture/Hole; Material Puncture/Hole

  THE USER FACILITY REPORTED THAT DURING A WAVELINQ PROCEDURE, THE 5FR GLIDESHEATH SLENDER SHEATH DEVICE WAS INSERTED INTO THE ULNAR VEIN. WHEN THE DILATOR WAS REMOVED IT WAS SEEN TO HAVE A HOLE IN THE SIDE OF THE DISTAL DILATOR CANNULA IN ADDITION TO THE END HOLE OF THE DILATOR. THE SHEATH WAS IN THE WRONG VESSEL TO BEGIN WITH, SO IT HAD TO BE REMOVED. ACCESS WAS REGAINED USING A NEW 5 FR SLENDER. THE BLOOD LOSS WAS LESS THAN 250CC'S. THE PATIENT WAS STABLE CONDITION. THE PROCEDURE OUTCOME WAS SUCCESSFUL. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED.

  Patient problems: Blood Loss

  MAUDE report 9776101 ↗
• MalfunctionSep 5, 2019Unraveled Material; Unraveled Material

  THE USER FACILITY REPORTED THAT A PHYSICIAN WAS USING A GLIDESHEATH SLENDER NITINOL KIT AND WHEN TRAVERSING THE WIRE IN THE SHEATH, HE NOTICED SOMETHING DID NOT FEEL RIGHT. THE PHYSICIAN PULLED THE WIRE OUT OF THE SHEATH TO FIND IT UNRAVELED AND UNUSABLE. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS SUCCESSFUL. THERE WAS NO PATIENT INJURY OR SURGICAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8964788 ↗
• MalfunctionJul 19, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT THE INVOLVED GLIDESHEATH SLENDER DEVICE HARD PLASTIC FLUSH PORT DETACHED FROM SOFT RUBBER PORTION DURING THE CASE. THEY WERE ABLE TO GET A DILATOR AND WIRE BACK THROUGH IT AND EXCHANGED IT OUT FOR ANOTHER ONE WITHOUT INCIDENT. THE PATIENT WAS IN STABLE CONDITION, AND THE OUTCOME WAS POSITIVE. THERE WAS NO COMPLICATION; BLOOD LOSS WAS LESS THAN 250CC. ADDITIONAL INFORMATION WAS RECEIVED ON JULY 12, 2019. THE SUBJECT COMPONENT AREA WAS THE CAP AT THE HOUSING, WHERE THE ISSUE OCCURRED. THE EVENT OCCURRED DURING A LOWER EXTREMITY ANGIOGRAM. ADDITIONAL INFORMATION WAS RECEIVED ON JULY 15, 2019. THE 3WSC CAME DISCONNECTED FROM THE SIDE TUBE.

  Patient problems: Blood Loss

  MAUDE report 8806701 ↗
• MalfunctionJul 16, 2019Material Separation; Material Separation

  ADDITIONAL INFORMATION WAS RECEIVED ON(B)(6)2019. THEY REPLACED THE WIRE TO COMPLETE THE CASE. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8793381 ↗
• MalfunctionJul 16, 2019Material Separation; Material Separation

  ADDITIONAL INFORMATION WAS RECEIVED ON JUNE 26, 2019. THEY REPLACED THE WIRE TO COMPLETE THE CASE. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8793379 ↗
• InjuryMay 10, 2019Material Separation; Material Separation

  ADDITIONAL INFORMATION WAS RECEIVED ON MAY 10, 2019. THE DOCTOR AT (B)(6) WAS PERFORMING A DIAGNOSTIC LEFT HEART CATHETERIZATION. THE DOCTOR ADVANCED THE ACCESS WIRE THROUGH THE ACCESS NEEDLE MULTIPLE TIMES RESULTING IN THE WIRE TIP TO PROLAPSE ON ITSELF AND FORM A KNOT. AS THE DOCTOR FELT RESISTANCE, HE REMOVED THE WIRE AND NEEDLE. A TR BAND WAS PLACED ON THE PROCEDURE SITE AND HEMOSTASIS WAS SUCCESSFULLY ACHIEVED. THE DOCTOR THEN MOVED UP THE ARM CLOSER TO THE ELBOW TO GAIN HIS SECOND ACCESS. ACCESS WAS SUCCESSFUL WITH A GLIDESHEATH SLENDER SHEATH. THE DIAGNOSTIC PROCEDURE WAS COMPLETED, AND A TR BAND WAS PLACED ON THE PATIENT TO ACHIEVE HEMOSTASIS. THE STAFF ASKED THE DOCTOR IF THE PATIENT'S WRIST WAS GOING TO BE EVALUATED. THE WRIST WAS X-RAYED IN RECOVERY AND IT WAS DISCOVERED THAT A PORTION OF THE WIRE REMAINED IN THE PATIENT. THE PATIENT WAS SENT TO VASCULAR SURGERY FOR CONSULT. THE VASCULAR SURGEON FROM MERCY WAS CONSULTED. AN ANGIOGRAM WAS PERFORMED. IT WAS DETERMINED THAT THE WIRE WAS EMBEDDED IN THE SOFT TISSUE, NOT IN THE ARTERY. THE VASCULAR SURGEON DETERMINED TO LEAVE THE WIRE IN THE PATIENT BECAUSE THE WIRE BEING LEFT IN THE PATIENT WAS NOT HARMFUL TO THE PATIENT. HE

  Patient problems: Device Embedded In Tissue or Plaque; Thrombosis

  MAUDE report 8601077 ↗
• MalfunctionSep 13, 2018Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT DURING PULLBACK OF A BOSTON CHARGER .035 6X120 PTA BALLOON, THE BALLOON BROUGHT THE GLIDESHEATH BACK WITH IT CAUSING IT TO PROLAPSE. THE PATIENT WAS REPORTED TO BE FINE. THE PROCEDURE OUTCOME WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED ON 9/10/2018. THE PROCEDURE BEING PERFORMED WAS A PERIPHERAL PROCEDURE (LEG CASE) BEING PERFORMED VIA PEDAL ACCESS. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7872343 ↗
• MalfunctionJul 19, 2018Material Twisted/Bent; Material Twisted/Bent

  THE USER FACILITY REPORTED THAT UPON REMOVAL OF A BARD LUTONIX BALLOON, THE SHEATH INVERTED AND FOLDED ON ITSELF BACK UP THROUGH THE HUB WHEN USING THE GLIDE SHEATH SLENDER DEVICE. THE PATIENT WAS STABLE. THE PROCEDURE OUTCOME WAS A SUCCESS. ADDITIONAL INFORMATION WAS RECEIVED ON 7/5/2018: THE PROCEDURE BEING PERFORMED WAS A PERIPHERAL VASCULAR INTERVENTION (PVI).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7703453 ↗
• MalfunctionJul 10, 2018Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT AFTER THE SHEATH WAS INSERTED INTO THE LEFT RADIAL ARTERY UNDER ULTRA SOUND GUIDANCE, THE ACCESS WIRE AND DILATOR WERE REMOVED. A .035 GLIDEWIRE ADVANTAGE AND 5 FR PIGTAIL CATHETER WERE ADVANCED INTO THE LEFT SUBCLAVIAN ARTERY. AT THIS POINT IT WAS NOTED THAT THE SHEATH WAS LEAKING FROM THE HUB. THE PIGTAIL CATHETER AND 5FR GLIDESHEATH SLENDER WERE REMOVED AND A STANDARD 5FR TERUMO PINNACLE SHEATH WAS INSERTED OVER THE WIRE. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THE PROCEDURE WAS COMPLETED. THE PATIENT WAS STABLE.

  Patient problems: Blood Loss

  MAUDE report 7673139 ↗
• MalfunctionFeb 21, 2018Folded; Folded

  THE USER FACILITY REPORTED A PEDAL CASE USING A 4/5 GLIDESHEATH SLENDER AND A .035 METACROSS BALLOON. THE BALLOON WOULD NOT DEFLATE ENTIRELY AND INVERTED THE SHEATH. THERE WERE NO ISSUES, IT WAS A SUCCESSFUL PROCEDURE. ADDITIONAL INFORMATION RECEIVED ON JANUARY 24, 2018. THE REPORTED BLOOD LOSS WAS LESS THAN 250CC, AND THE PATIENT IS IN STABLE CONDITION.

  Patient problems: Blood Loss; No Consequences Or Impact To Patient

  MAUDE report 7286080 ↗