TREVO NXT 6MM X 37MM - CE

Description of Event or Problem

IT WAS REPORTED THAT THE RETRIEVER (SUBJECT DEVICE) WAS BROKEN INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

Additional Manufacturer Narrative

BASED ON THE RESULTS OF THE DEVICE HISTORY RECORD (DHR) REVIEW, THERE IS NO INDICATION THAT THE DEVICE, LABELING OR PACKAGING FAILED TO MEET ITS SPECIFICATIONS WHEN RELEASED. THE SUBJECT DEVICE IS NOT AVAILABLE; THEREFORE, FUNCTIONAL TESTING AS WELL AS PHYSICAL ANALYSIS CANNOT BE PERFORMED. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED, AND IT COULD NOT BE DEFINITIVELY DETERMINED IF THE DEVICE FAILED TO MEET SPECIFICATIONS BECAUSE THE PRODUCT WAS NOT RETURNED. THE REPORTED EVENT IS COVERED IN THE DEVICE DIRECTIONS FOR USE (DFU). AS WELL, THE RISK OF THE REPORTED EVENT IS DOCUMENTED IN THE RISK DOCUMENTATION AND THERE ARE CURRENT CONTROLS TO MITIGATE THE RISK OF THE AS REPORTED EVENT. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER INDICATED THE PATIENT ANATOMY WAS SEVERELY TORTUOUS WHICH MAY HAVE CONTRIBUTED TO THE EVENT, CONTINUOUS FLUSH WAS MAINTAINED THROUGHOUT THE PROCEDURE AND NO DAMAGE NOTED TO THE PACKAGING PRIOR TO PREPARATION OF THE DEVICE. WHILE THERE ARE A NUMBER OF POTENTIAL CAUSES FOR THE REPORTED ISSUE, BECAUSE REVIEW OF AVAILABLE INFORMATION FAILED TO IDENTIFY A DEFINITIVE CAUSE AND THE DEVICE WAS NOT RETURNED, A CAUSE OF 'UNDETERMINABLE' SHALL BE ASSIGNED TO THE AS REPORTED ¿RETRIEVER FRACTURE/BROKEN DURING USE¿.

Additional Manufacturer Narrative

THE DEVICE IS NOT AVAILABLE TO THE MANUFACTURER.

Description of Event or Problem

IT WAS REPORTED THAT THE RETRIEVER (SUBJECT DEVICE) WAS BROKEN INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.