VASOVIEW HEMOPRO

Additional Manufacturer Narrative

TRACKWISE #: (B)(4). THE LOTS # 3000378654, 3000377320 AND 3000376883 HISTORY RECORD REVIEW WAS COMPLETED. THERE WERE NCMRS , REWORK, OR DEVIATIONS DOCUMENTED FOR THE REPORTED LOT NUMBER. BASED ON THE DHR/LHR REVIEW RESULTS, IT WAS DETERMINED THAT THERE IS NO RELATION BETWEEN THE BATCH MANUFACTURING PROCESS AND THE REPORTED FAILURE.

Description of Event or Problem

N/A.

Additional Manufacturer Narrative

TW ID (B)(4) SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO US, A TECHNICAL EVALUATION CANNOT BE PERFORMED. PER OUR STANDARD SOP'S, ALL EVENTS ARE TRACKED AND TRENDED TO DETERMINE WHETHER OR NOT ANY TRENDS DEVELOP. H3 OTHER TEXT : DEVICE DISCARDED.

Description of Event or Problem

THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VESSEL HARVESTING PROCEDURE, VASOVIEWHEMPRO VH-3500 CAUTERY TIP CONTINUED TO GO THROUGH THE C-ARM. THE CUTTING TOOL WAS BENT SO IT WAS GETTING IN THE WAY OF THE C-ARM PATH. HARVESTER TRIED TO BEND IT, BUT NOTHING WORKED. HARVESTER WAS UNABLE TO USE THE DEVICE. A NEW DEVICE WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS A SLIGHT PROCEDURAL DELAY. THERE WAS NO PATIENT HARM.