EXPIRATION DATE - UNKNOWN DUE TO UNKNOWN LOT NUMBER. UDI - UNKNOWN DUE TO UNKNOWN LOT NUMBER. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. DEVICE MANUFACTURE DATE - UNKNOWN DUE TO UNKNOWN LOT NUMBER. (B)(4). THE ACTUAL DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION OF THE ACTUAL DEVICE WAS UNABLE TO BE CONDUCTED. THE PRODUCTION LOT NUMBER WAS NOT PROVIDED BY THE USER FACILITY, WHICH PREVENTED A MEANINGFUL REVIEW OF THE DEVICE HISTORY RECORD. WITH NO RETURN OF THE ACTUAL DEVICE, THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION.
D
Patient 1
THE USER FACILITY REPORTED THAT THE INVOLVED TR BAND WAS USED. THERE WAS A RADIAL COMPLICATION THAT HAD OCCURRED. THE COMPLICATION WAS OBSERVED 1.5 HOURS AFTER THE TR BAND PLACEMENT AND WAS SO SEVERE THAT IT REQUIRED A FASCIOTOMY. IT SOUNDED LIKE EITHER THE BAND WAS PLACED TOO DISTAL TO ARTERY ENTRY SITE AND THE DOCTOR TOOK A VERY AGGRESSIVE ANGLE FOR ACCESS RESULTING IN A PROXIMAL VESSEL ENTRY SITE. ADDITIONAL INFORMATION WAS RECEIVED ON 21FEB2020. THE PROCEDURE THAT WAS PERFORMED PRIOR TO THE TR BAND BEING USED WAS A HEART CATHETERIZATION. A 6FR SHEATH WAS USED. THE RADIAL ARTERY WAS ACCESSED. THE TR BAND WAS REMOVED, AND AN HOUR AND A HALF LATER, THE PATIENT DEVELOP SYMPTOMS OF COMPARTMENT SYNDROME. THE PATIENT'S CONDITION WAS STABLE.