Block h6 (device codes): device code a0501 captures the reportable event of internal bolster detached.Block h10: the returned endovive securi-t replacement bolster was analyzed.Upon visual assessment, it was observed that the bolster was detached/separated.In addition, the silicon tube had evidence traces of adhesion and the bolster was torn.Therefore the complaint is confirmed for bolster detached.Based on the condition of the returned device, engineers determined that based upon the adhesion traces found in the silicone tube as well as the detachment and damage to the bolster it suggests that the device was subjected to excessive force; perhaps the manipulation, technique used, or patient's anatomical conditions could have contributed to this event.Boston scientific has determined the most probable cause of this complaint is adverse event related to procedure.
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