GLIDESHEATH 15-1050Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00389701009926), received between Oct 26, 2016 and Jan 13, 2024 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJan 13, 2024Difficult to Remove; Physical Resistance/Sticking; Difficult to Remove; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED ON 04MAR2024: ACCORDING TO THE PATIENTS MEDICAL RECORD THERE WAS NO FINDING SUGGESTIVE OF TORTUOUS ANATOMY. THE MICROWIRE (GUIDEWIRE) USED TO GAIN ACCESS TO THE RIGHT RADIAL ARTERY FOR THE CARDIAC CATHETERIZATION PROCEDURE WAS UNABLE TO BE REMOVED BY THE PROCEDURALIST. THE PATIENT'S CONDITION WAS STABLE FOLLOWING THE PROCEDURE. THE ESTIMATED BLOOD LOSS WAS NOTED TO BE LESS THEN 250CC. THE RETAINED MICROWIRE WAS REMOVED DURING A SURGICAL PROCEDURE AND IS NOT AVAILABLE FOR EVALUATION. NO FURTHER INTERVENTION REQUIRED, ASIDE FROM THE DESCRIBED CUT DOWN PERFORMED TO REMOVE THE WIRE.

  Patient problems: Foreign Body In Patient

  MAUDE report 18509578 ↗
• InjuryDec 27, 2023Peeled/Delaminated; Physical Resistance/Sticking; Peeled/Delaminated; Physical Resistance/Sticking

  TERUMO MEDICAL RECEIVED AN FDA MEDWATCH REPORT NUMBER MW5147927. THE EVENT DESCRIPTION STATES THAT "UPON ACCESS TO VESSEL (HEART CATHETERIZATION), WIRE (INTRODUCER SHEATH) WAS INSERTED IN NEEDLE FROM KIT. THE WIRE WOULD NOT ADVANCE. UPON ATTEMPTED REMOVAL OF WIRE, THE WIRE WAS APPEARED SHEARED. PIECE OF WIRE NOTED UNDER FLUORO IN RIGHT WRIST. DEVICE EMBEDDED IN TISSUE OR PLAQUE."

  Patient problems: Foreign Body In Patient

  MAUDE report 18402214 ↗
• InjuryJun 24, 2021Failure to Advance; Failure to Advance

  TERUMO MEDICAL RECEIVED A USER FACILITY MEDWATCH REPORT # (B)(4). THE EVENT DESCRIPTION STATES: "DURING A CARDIAC CATHETERIZATION, THE PROCEDURALIST ATTEMPTED TO ADVANCE THE CATHETER VIA THE LEFT FEMORAL ARTERY, BUT THE AORTIC VALVE DID NOT OPEN SUFFICIENTLY TO ALLOW THE CATHETER TO ENTER FURTHER. THE CATHETER WAS REMOVED, AND INSTEAD A DIFFERENT CATHETER WAS ADVANCED TO THE ASCENDING AORTA. FOLLOWING THE CATHETERIZATION, A CURVILINEAR FOREIGN OBJECT NEAR THE LEFT FEMORAL HEAD/NECK AREA WAS SEEN ON RADIOGRAPH AND IS SUSPECTED TO BE A WIRE TIP FROM THE GLIDESHEATH GUIDEWIRE." THE ORIGINAL INTENDED PROCEDURE WAS A LEFT HEART CATHETERIZATION VIA LEFT FEMORAL ARTERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 12056639 ↗
• MalfunctionNov 13, 2020Unraveled Material; Unraveled Material

  ADDITIONAL INFORMATION WAS RECEIVED 24DEC2020. IT WAS BELIEVED THAT THE SHEATH WAS IN WHEN THE GUIDEWIRE WAS PULLED BACK. THEY DISCUSSED IF IT WAS THROUGH THE ACCESS NEEDLE AND THEY SAID NO. SINCE THEY HAD VENOUS ACCESS, THEY QUESTIONED IF IT GOT CAUGHT IN A VALVE. ADDITIONAL INFORMATION WAS RECEIVED 29DEC2020. THEY SAID IT WAS IN A VEIN IN THE UPPER ARM AREA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10835085 ↗
• MalfunctionOct 26, 2016Fracture; Uncoiled; Fracture; Uncoiled

  THE USER FACILITY REPORTED UNCOILING OF THE WIRE DURING A PROCEDURE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: THE CASE USED A 5FR GLIDESHEATH; AFTER THE SHEATH WAS PLACED IN THE PATIENT THE DILATOR WAS REMOVED AND THEN THE WIRE; UPON PULLING THE WIRE OUT, IT WAS NOTED THAT THE TIP OF THE WIRE WAS SHREDDING AND UNCOILING; UNDER FLURO THERE WAS NOTHING OBSERVED TO BE BROKEN OFF IN THE PATIENT; THE PROCEDURE OUTCOME WAS GOOD; AND THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6057707 ↗