ACCUSTICK? II

Additional Manufacturer Narrative

B3 - DATE OF EVENT: DATE OF EVENT WAS APPROXIMATED TO 05/01/2026 AS THE EXACT EVENT DATE WAS NOT REPORTED.

Description of Event or Problem

IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. A .038 ACCUSTICK II WAS SELECTED FOR USE. DURING ADVANCING, IT WAS NOTED THAT THERE WAS DIFFICULTY ADVANCING THROUGH PATIENT'S SKIN. CONSEQUENTLY, THE TIP OF THE SHEATH BROKE OFF. THE DEVICE WAS PULLED OUT, HOWEVER, THE BROKEN TIP REMAINED INSIDE. ANOTHER ACCUSTICK II WAS TRIED TO ADVANCE HOWEVER, IT WAS ALSO COULD NOT ADVANCE THROUGH THE PATIENT'S SKIN. THE PROCEDURE WAS CANCELLED. PHYSICIAN BELIEVES PATIENT HAS SUPER FIBROUS SKIN AND THAT MAY BE THE ISSUE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT WAS EXPECTED TO FULLY RECOVER.