ULTRA ICE PLUS¿

Additional Manufacturer Narrative

IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE INVESTIGATION CONCLUSION IS OPERATIONAL CONTEXT AS THE PRODUCT MEETS THE DESIGN AND MANUFACTURE SPECIFICATION BUT DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, PERFORMANCE WAS LIMITED. (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT A CATHETER BREAK / DETACHMENT OCCURRED. AN ULTRA ICE PLUS ULTRASOUND IMAGING CATHETER AND ANOTHER MANUFACTURER¿S SNARE WERE SELECTED FOR USE DURING AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LEAD EXTRACTION PROCEDURE IN THE RIGHT ATRIUM. DURING A TWISTING MANEUVER WITH THE SNARE RETRIEVAL DEVICE, THE CATHETER WAS ENTRAPPED WHILE IT WAS ROTATING AND THEREFORE BECAME DAMAGED. DURING RETRIEVAL OF THE DEVICES, THE PIEZOELECTRIC CRYSTAL BROKE AND DETACHED FROM THE CATHETER BODY. IT WAS NOTED THE DETACHMENT ¿PROBABLY¿ OCCURRED INSIDE THE SHEATH. ALL COMPONENTS WERE REMOVED FROM THE PATIENT WITHOUT PROBLEMS AND THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS.