ZEBRA

Description of Event or Problem

ON (B)(6) 2025, DURING A RADIAL ACCESS PROCEDURE, THE PHYSICIAN OBSERVED BLOOD ESCAPING FROM THE HUB OF A ZEBRA CATHETER DURING USE. THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER ZEBRA CATHETER, ALLOWING THE PROCEDURE TO BE COMPLETED WITHOUT FURTHER INCIDENT. A CUSTOMER-PROVIDED IMAGE TAKEN AT THE TIME OF THE EVENT SHOWED THE CATHETER INTACT IN ONE PIECE WITH A LOCALIZED SURFACE DISCONTINUITY (FRACTURE) JUST DISTAL TO THE STRAIN RELIEF. THE USER REPORTED THAT NO RESISTANCE OR TORQUING WAS ENCOUNTERED DURING USE. EVALUATION OF THE RETURNED DEVICE SHOWED THAT THE CATHETER WAS FRACTURED JUST DISTAL TO THE STRAIN RELIEF (1-2 MM), A LOCATION THAT EXPERIENCES ELEVATED MECHANICAL STRESS WHEN SUBJECTED TO TIGHT-RADIUS BENDING OR OFF-AXIS LOADING. NO EVIDENCE OF DESIGN OR MANUFACTURING NONCONFORMANCE (E.G., IMPROPER LAMINATION, ABNORMAL FEED GAP, EXPOSED REINFORCEMENT, OR STRUCTURAL ANOMALY) WAS IDENTIFIED.