On 17dec2019 silk road medical contacted osb to inform them of medical device reports that were not reported within the mandatory reporting timeframe.It is noted here, per fda's request, that this mdr was identified as part of a complaint handling remediation effort associated with capa-(b)(4).The product in complaint was not returned to the manufacturer for analysis.A review of the manufacturing records for this device was completed and no issues were identified that could lead to the adverse event reported.Complaints will continue to be monitored for any trends.
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During a tcar procedure, the physician had difficulty engaging the external carotid due to the significant angle coming off of the common.After several unsuccessful attempts, the physician stopped.The guidewire was advanced to just short of the bifurcation, and the micropuncture sheath was exchanged with the nps arterial sheath.Two views were taken, but no dissection was visualized, and.014" wire was advanced into right internal carotid artery.Wire quickly began to prolapse in right internal carotid artery and dissection was realized.Several attempts were made to pull arterial sheath tip back and work around dissection to no avail.Decision was made to convert to cea.Patient had successful cea, and came out of surgery with all vitals normal and neuro intact.
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