Terumo has received the device for evaluation; however, the investigation has yet to be completed.Terumo plans on submitting a follow-up report when the investigation is complete and when more information becomes available.For this reason, terumo references evaluation.(b)(4).
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This follow-up report is submitted to fda in accord with applicable regulations ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on october 13, 2020.Upon further investigation of the reported event, the following information is new and/or changed: b5 (updated describe event or problem).D4 (additional device information - added exp date).G4 (date received by manufacturer).G7 (indication that this is a follow-up report).H2 (follow-up due to additional information and device evaluation).H3 (device evaluated by manufacturer).H6 (identification of evaluation codes 10, 11, 3331, 3259, 19).Method code #1: 10 - testing of actual/suspected device.Method code #2: 11 - testing of device from same lot/batch retained by manufacturer.Method code #3: 3331 - analysis of production records.Results code: 3259 - improper physical structure.Conclusions code: 19 - cause traced to user.The affected sample was inspected upon receipt and confirmed to have burn marks and a hole in the v-cutter.A representative retention sample was reviewed and electrically tested with no anomalies and all electrical tests within specification.During the manufacturing process, all vsp550 are visually inspected and tested for functionality and performance along with inspection for v-cutter mechanism, prior to packaging.Based on review of past complaints, the cracked/fractured distal end of the v-cutter most likely resulted from excessive force applied to the distal end of the v-cutter during the procedure.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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