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Description of Event or Problem

IT WAS REPORTED THAT THE DIAGNOSTIC ULTRASOUND CATHETER PRODUCED A POOR IMAGE DURING THE PROCEDURE. A THROMBUS WAS NOTICED AT THE TIP OF THE CATHETER DURING THE PROCEDURE. THE PROCEDURE WAS ABORTED, AND THE PATIENT WAS ADMITTED TO ANTICOAGULATION. AFTER TREATMENT, THE PATIENT TESTED NEGATIVE FOR A THROMBUS AND WAS IN GOOD CONDITION.

Additional Manufacturer Narrative

THE COMPLAINT DEVICE WAS RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS (SSS) FOR AN EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO VISIBLE DAMAGE WAS DETECTED. THE DEVICE INSPECTION INDICATED THAT THE COMPLAINT DEVICE MET ALL INSPECTION AND TEST CRITERIA.ALTHOUGH A THROMBUS WAS DETECTED DURING THE PROCEDURE, IT IS UNKNOWN IF IT WAS DIRECTLY CAUSED BY THE SSS DIAGNOSTIC ULTRASOUND CATHETER. A THROMBUS IS A KNOWN POSSIBLE ADVERSE REACTION TO CARDIAC CATHETERIZATION PROCEDURES.