GLIDESHEATH SLENDER RM*ES6F10HAURecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04987350717986), received between Feb 17, 2017 and Jul 23, 2018 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJul 23, 2018Break; Break

  THE USER FACILITY REPORTED THAT A DOCTOR WAS PERFORMING A RADIAL PROCEDURE AND THE GLIDE SHEATH SLENDER HAD THE DISTAL SHAFT BREAK OFF AND HAD TO BE REMOVED FROM THE PATIENTS RADIAL ARTERY. ADDITIONAL INFORMATION WAS RECEIVED ON 7/10/18. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. THERE WAS ANOTHER CATHETER USED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7710710 ↗
• MalfunctionJul 19, 2018Material Separation; Material Separation

  THE USER FACILITY REPORTED THE RADIFOCUS WIRE SHREDDED. ADDITIONAL INFORMATION WAS RECEIVED ON JUNE 6, 2018: THE PATIENT'S CONDITION WAS GOOD. PATIENT ACCESS FOR A CARDIAC CATHETERIZATION WAS BEING PERFORMED. THE DOCTOR HAD AN RN OPEN ANOTHER GLIDESHEATH SLENDER PACKAGE TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO OTHER DEVICES WERE USED WITH THIS WIRE. THE WIRE WAS SHREDDED OR NICKED. ADDITIONAL INFORMATION WAS RECEIVED ON JUNE 14, 2018: THE REPORTED EVENT HAPPENED DURING ACCESS. THE WIRE WAS NOT SEVERED, AND DID NOT HAVE ANY PIECE BROKEN OFF IN THE PATIENT. IT WAS INTACT, HOWEVER, DAMAGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7702536 ↗
• MalfunctionJan 24, 2018Kinked; Kinked

  THE USER FACILITY REPORTED A DEFECTIVE GLIDESHEATH KIT. ON (B)(6) 2017, WHEN FLUSHING SHEATH PRIOR TO REMOVAL FROM PACKAGE, IT WOULD NOT FLUSH. THE DEVICE WAS FOUND TO HAVE KINK. THE DEFECTIVE SHEALTH WAS REPLACED WITH A NEW SHEATH AND IT WORKED FINE (LOT# 170810). THE PATIENT WAS STABLE. THE PROCEDURE OUTCOME WAS SUCCESSFUL. THE UF MEDWATCH REPORT (B)(4) WAS RECEIVED ON (B)(6) 2017 WITH THE FOLLOWING INFORMATION. WHEN FLUSHING SHEATH PRIOR TO REMOVAL FROM PACKAGE, IT WOULD NOT FLUSH, FOUND THE DEVICE HAD A KINK. IT WAS REPLACED WITH A NEW SHEALTH AND IT WORKED FINE (LOT #170810). THE ORIGINAL INTENDED PROCEDURE AS HEART CATH (ACCESS). THE PATIENT WAS NOT EFFECTED BY THE KINK. THE DEVICE WAS NOT PLACED IN THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7216694 ↗
• InjuryMay 23, 2017Peeled/Delaminated; Peeled/Delaminated

  THE USER FACILITY REPORTED THE COATING SHEARED OFF WITH THE INVOLVED GLIDESHEATH SLENDER DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: THE PLASTIC JACKET WIRE WAS PUT INTO A METAL NEEDLE BY THE PHYSICIAN IN THE FEMORAL ARTERY; PART OF THE COATING SHEARED OFF THE WIRE; A SNARE WAS USED TO RETRIEVE THE SHEARED OFF COATING; THE PROCEDURE OUTCOME WAS GOOD; AND IT WAS REPORTED THAT THE PATIENT'S CONDITION WAS GOOD. ADDITIONAL INFORMAITON WAS RECEIVED ON (B)(6) 2017. ALL PIECES OF THE SHEERED PRODUCT WAS RECOVERED AND THE PATIENT WAS FINE.

  Patient problems: Foreign Body In Patient

  MAUDE report 6585411 ↗
• MalfunctionFeb 17, 2017Peeled/Delaminated; Peeled/Delaminated

  THE USER FACILITY REPORTED A SUBSTANCE PEELING OFF OF THE INVOLVED DEVICE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: AFTER REMOVING THE NEEDLE, THE WIRE WAS ADVANCED THROUGH THE CANNULA; WHEN A FLASH OF BLOOD OCCURRED THE PLASTIC CANNULA WAS THEN BACKED OFF OF THE INTRODUCER WIRE; WHEN ADVANCING THE DILATOR/SHEATH OVER THE WIRE IT PASSED THROUGH THE SKIN LAYERS AND WAS INTRODUCED INTO THE ARTERY WHEN THE URETHANE COATING APPEARED TO BE PEELING OR GETTING SCRAPED OFF OF THE INTRODUCER WIRE; THE DOCTOR THEN WIPED THE SHEARED COATING OFF THE WIRE WITH A 4*4 AND CONTINUED THE PROCEDURE; AND THERE WAS NOT PATIENT INJURY OR MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6340111 ↗
• MalfunctionFeb 17, 2017Peeled/Delaminated; Peeled/Delaminated

  THE USER FACILITY REPORTED A SUBSTANCE PEELING OFF OF THE INVOLVED DEVICE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: AFTER REMOVING THE NEEDLE, THE WIRE WAS ADVANCED THROUGH THE CANNULA; WHEN A FLASH OF BLOOD OCCURRED THE PLASTIC CANNULA WAS THEN BACKED OFF OF THE INTRODUCER WIRE; WHEN ADVANCING THE DILATOR/SHEATH OVER THE WIRE IT PASSED THROUGH THE SKIN LAYERS AND WAS INTRODUCED INTO THE ARTERY WHEN THE URETHANE COATING APPEARED TO BE PEELING OR GETTING SCRAPED OFF OF THE INTRODUCER WIRE; THE DOCTOR THEN WIPED THE SHEARED COATING OFF THE WIRE WITH A 4*4 AND CONTINUED THE PROCEDURE; AND THERE WAS NOT PATIENT INJURY OR MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6340089 ↗
• MalfunctionFeb 17, 2017Peeled/Delaminated; Peeled/Delaminated

  THE USER FACILITY REPORTED A SUBSTANCE PEELING OFF OF THE INVOLVED DEVICE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: AFTER REMOVING THE NEEDLE, THE WIRE WAS ADVANCED THROUGH THE CANNULA; WHEN A FLASH OF BLOOD OCCURRED THE PLASTIC CANNULA WAS THEN BACKED OFF OF THE INTRODUCER WIRE; WHEN ADVANCING THE DILATOR/SHEATH OVER THE WIRE IT PASSED THROUGH THE SKIN LAYERS AND WAS INTRODUCED INTO THE ARTERY WHEN THE URETHANE COATING APPEARED TO BE PEELING OR GETTING SCRAPED OFF OF THE INTRODUCER WIRE; THE DOCTOR THEN WIPED THE SHEARED COATING OFF THE WIRE WITH A 4*4 AND CONTINUED THE PROCEDURE; AND THERE WAS NOT PATIENT INJURY OR MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6340084 ↗
• MalfunctionFeb 17, 2017Peeled/Delaminated; Peeled/Delaminated

  THE USER FACILITY REPORTED A SUBSTANCE PEELING OFF OF THE INVOLVED DEVICE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: AFTER REMOVING THE NEEDLE, THE WIRE WAS ADVANCED THROUGH THE CANNULA; WHEN A FLASH OF BLOOD OCCURRED THE PLASTIC CANNULA WAS THEN BACKED OFF OF THE INTRODUCER WIRE; WHEN ADVANCING THE DILATOR/SHEATH OVER THE WIRE IT PASSED THROUGH THE SKIN LAYERS AND WAS INTRODUCED INTO THE ARTERY WHEN THE URETHANE COATING APPEARED TO BE PEELING OR GETTING SCRAPED OFF OF THE INTRODUCER WIRE; THE DOCTOR THEN WIPED THE SHEARED COATING OFF THE WIRE WITH A 4*4 AND CONTINUED THE PROCEDURE; AND THERE WAS NOT PATIENT INJURY OR MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6340065 ↗
• MalfunctionFeb 17, 2017Peeled/Delaminated; Peeled/Delaminated

  THE USER FACILITY REPORTED A SUBSTANCE PEELING OFF OF THE INVOLVED DEVICE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: AFTER REMOVING THE NEEDLE, THE WIRE WAS ADVANCED THROUGH THE CANNULA; WHEN A FLASH OF BLOOD OCCURED THE PLASTIC CANNULA WAS THEN BACKED OFF OF THE INTRODUCER WIRE; WHEN ADVANCING THE DILATOR/SHEATH OVER THE WIRE IT PASSED THROUGH THE SKIN LAYERS AND WAS INTRODUCED INTO THE ARTERY WHEN THE URETHANE COATING APPEARED TO BE PEELING OR GETTING SCRAPED OFF OF THE INTRODUCER WIRE; THE DOCTOR THEN WIPED THE SHEARED COATING OFF THE WIRE WITH A 4*4 AND CONTINUED THE PROCEDURE; AND THERE WAS NOT PATIENT INJURY OR MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6340051 ↗