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 december 22, 2020.Upon further investigation of the reported event, the following information is new and/or changed: identification of evaluation codes 3123, 4614, 4582, 1071, 10, 11, 3331, 642, 19.Component code: 3123 - tip.Health effect - impact code: 4614 - serious injury/ illness/ impairment, health effect - clinical code: 4582 - no clinical signs, symptoms or conditions, medical device problem code: 1071 - thermal decomposition of device, type of investigation #1:10 - testing of actual/suspected device, type of investigation #2: 11 - testing of device from same lot/batch retained by manufacturer, type of investigation #3: 3331 - analysis of production records, investigation findings: 642 - thermal problem, investigation conclusions: 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.The v-cutter on the retention sample was fully intact.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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