inforMED
MalfunctionMSD

GLIDEPATH

Received Apr 22, 2026 · Event occurred Mar 29, 2026

Report 3006260740-2026-02728 · MDR key 24952431

Device

Generic name

Dialysis Catheter

Catalog number

6393350

Lot number

REKT1851

Product problems

  • Difficult or Delayed Separation

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

H11: AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE PERFORMED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. HOWEVER, PHOTO WAS PROVIDED FOR REVIEW. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. SECTION A THROUGH F: THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

Description of Event or Problem

ON (B)(6) 2026, A PATIENT UNDERWENT A RIGHT FEMORAL VEIN CATHETER PLACEMENT PROCEDURE USING GLIDEPATH HEMODIALYSIS CATHETER. DURING THE PROCEDURE, IT WAS NOTED THAT THE 8F SKIN EXPANDER COULD NOT BE USED SMOOTHLY TO EXPAND THE SKIN. THERE WAS NO REPORTED PATIENT INJURY.