GLIDESHEATH SLENDER RM*RS6F10PARecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04987350718068), received between Feb 14, 2017 and Jun 1, 2018 — classified as 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Too Rigid or Stiff” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2018Fracture; Fracture

  THE USER FACILITY REPORTED THE GLIDESHEATH SLENDER SHEATH WAS INSERTED AND BROKE APART IN THE PATIENT DURING THE PROCEDURE. THE COCKTAIL WAS GIVEN AND THE SHEATH WAS FLUSHED. THE WIRE (.035 J) AND THE DIAGNOSTIC TIGER WAS INSERTED WITHOUT RESISTANCE. THE CATHETER WAS THEN EXCHANGED. THE GUIDE CATHETER (FR4); INSERTED RUN-THROUGH THEN FFR ASCIST CATHETER. UPON INSERTION OF THE FFR CATHETER, RESISTANCE WAS MET. THE FFR CATHETER AND SHEATH WAS PULLED OUT AND SEEMED TO ACCORDION. THE PIECES WERE REMOVED AND THE PATIENT WAS NOT INJURED. THE PATIENT DID NOT DEVELOP A HEMATOMA. IT WAS REPORTED THAT THE PATIENT WAS FINE FOLLOWING THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A NEW SHEATH INSERTED. ADDITIONAL INFORMATION WAS RECEIVED ON 5/16/2018. THE PROCEDURE BEING PERFORMED WAS A LEFT HEART CATH. ALL OF THE PIECES WERE REMOVED AND DID NOT ACTUALLY SEPARATE IN THE PATIENT, IT JUST INVERTED WITHIN ITSELF, AND ONCE THEY REMOVED IT THEY PULLED IT WITH FORCEPS TO PROVE NOTHING BROKE OFF IN THE PATIENT AND THEREFORE NOTHING WAS LEFT IN THE PATIENT. BLOOD LOSS WAS REPORTED TO BE LESS THAN 1 LITER BUT MORE THAN 20 CC'S.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7562338 ↗
• InjuryJan 10, 2018Material Too Rigid or Stiff; Material Too Rigid or Stiff

  THE USER FACILITY REPORTED THEY USED TO USE 20-1060 AND SWITCHED TO THE SLENDER. THEY BELIEVE THE .021" WIRE IN THE SLENDER KIT IS STIFFER. THEY HAVE EXPERIENCED A FEW PSEUDO ANEURYSMS IN THE PAST MONTHS AND ATTRIBUTE IT TO THE STIFFER WIRE OR THE VASC BAND. ALL OF THE PATIENTS RECOVERED AND NO SURGERY WAS NEEDED. THE PROCEDURE WAS SUCCESSFUL.

  Patient problems: Pseudoaneurysm

  MAUDE report 7178444 ↗
• InjuryJan 10, 2018Material Too Rigid or Stiff; Material Too Rigid or Stiff

  THE USER FACILITY REPORTED THEY USED TO USE 20-1060 AND SWITCHED TO THE SLENDER. THEY BELIEVE THE .021" WIRE IN THE SLENDER KIT IS STIFFER. THEY HAVE EXPERIENCED A FEW PSEUDO ANEURYSMS IN THE PAST MONTHS AND ATTRIBUTE IT TO THE STIFFER WIRE OR THE VASC BAND. ALL OF THE PATIENTS RECOVERED AND NO SURGERY WAS NEEDED. THE PROCEDURE WAS SUCCESSFUL.

  Patient problems: Pseudoaneurysm

  MAUDE report 7178443 ↗
• InjuryJan 10, 2018Material Too Rigid or Stiff; Material Too Rigid or Stiff

  THE USER FACILITY REPORTED THEY USED TO USE 20-1060 AND SWITCHED TO THE SLENDER. THEY BELIEVE THE .021" WIRE IN THE SLENDER KIT IS STIFFER. THEY HAVE EXPERIENCED A FEW PSEUDO ANEURYSMS IN THE PAST MONTHS AND ATTRIBUTE IT TO THE STIFFER WIRE OR THE VASC BAND. ALL OF THE PATIENTS RECOVERED AND NO SURGERY WAS NEEDED. THE PROCEDURE WAS SUCCESSFUL.

  Patient problems: Pseudoaneurysm

  MAUDE report 7178442 ↗
• InjuryNov 14, 2017Break; Break

  TERUMO RECEIVED A FDA MW5072550 ON OCTOBER 16, 2017 THAT REPORTED THE FOLLOWING: DURING CARDIAC CATH USING R RADIAL ARTERY, PT WITH SEVERER RADIAL ARTERY SPASM - DIFFICULTY IN REMOVING THE 0.21 GUIDEWIRE DESPITE MORE PATIENT SEDATION, TNG SQ AND REST, ATTEMPT TO RESOLVE THE SPASM, REMOVE GUIDEWIRE. WIRE EVENTUALLY REMOVED, BUT DISTAL GUIDEWIRE FRAYED. FLUORO-SMALL PIECE RETAINED GUIDE. VASC CONSULT. RECOMMENDS LEAVE IN PLACE. DATES OF USE: (B)(6) 2017. DIAGNOSIS OR REASON FOH USE: CAD-CARDIAC CATHETERIZATION. ADDITIONAL INFORMATION WAS RECEIVED ON OCTOBER 26, 2017. THE WIRE FRAGMENT REMAINS IN RIGHT FOREARM OF THE PATIENT AND WAS EVALUATED BY A VASCULAR SURGEON WHO HAS RECOMMENDED TO LEAVE IT IN THE VESSEL. THE VESSEL STILL PROFESSES APPROPRIATELY, BUT THE PATIENT DID HAVE DISCOMFORT WITH PALPATION. ESTIMATED BLOOD LOSS WAS REPORTED TO BE LESS THAN 250CC. THE PATIENT IS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 7029846 ↗
• InjuryJun 30, 2017Physical Resistance; Physical Resistance

  THE USER FACILITY REPORTED DIFFICULTIES WITH THE INVOLVED DEVICE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: WHEN THE SHEATH WAS BEING INSERTED THERE WAS SIGNIFICANT RESISTANCE AND THE RIGHT RADIAL WAS ABORTED; CAUSE IS BEING ATTRIBUTED TO A FAULTY GLIDESHEATH SLENDER; THE CASE THEN WENT TO THE RFA; THE PATIENT WAS REPORTED TO BE STABLE; SIGNIFICANT HEMATOMA IN THE RIGHT WRIST POST PROCEDURE; AND THE PROCEDURE WAS SUCCESSFUL.

  Patient problems: Hematoma

  MAUDE report 6681694 ↗
• MalfunctionJun 15, 2017Material Puncture/Hole; Material Puncture/Hole

  THE USER FACILITY REPORTED DIFFICULTIES WITH THE INVOLVED DEVICE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: THE GLIDESHEATH SLENDER FAILED DURING PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED ON MAY 22, 2017. THE DOCTOR SUTURED AROUND THE GLIDESHEATH SLENDER AND LIKELY PUNCTURED THE DEVICE. THE DEVICE IS IN TWO PIECES. THERE WAS NO INJURY TO THE PATIENT. THE PROCEDURE OUTCOME WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6645129 ↗
• MalfunctionFeb 14, 2017Material Separation; Material Separation

  THE USER FACILITY REPORTED SHEATH BREAKAGE ON THE INVOLVED DEVICE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: THE DISTAL CATHETER PORTION OF THE DEVICE PROTRACTED THROUGH THE PORT OPENING AND SHEARED OFF; THE TUBE WAS HANGING OUT OF THE PATIENTS ARM; THEY WERE STILL ABLE TO USE A TR BAND AND PULL THE DEVICE OUT WITHOUT A PROBLEM; THE PROCEDURE WAS COMPLETED SUCCESSFULLY; AND THE PATIENT WAS REPORTED AS IN STABLE CONDITION. FOLLOW UP INFORMATION RECEIVED ON FEBRUARY 2, 2017 CONFIRMED THAT THE GSS SHEATH TUBE WAS SEPARATED FROM THE SHEATH HUB. WHEN THE DOCTOR ATTEMPTED TO PULL THE GUIDE CATHETER OUT OF THE SHEATH PORT, THE GUIDE CATHETER SEEMED TO PULL THE SHAFT OF THE SHEATH TUBING AS WELL. THE GUIDE CATHETER COULD BE REMOVED FROM THE SHEATH WITHOUT ANY ISSUES. THE SHEATH TUBING WAS SEPARATED FROM THE HUB WHEN ATTEMPTING TO REMOVE IT FROM THE ARTERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6329962 ↗