The results of the investigation are inconclusive since the reported device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.The material inspection report for the reported guide wire could not be reviewed, as the lot number was not provided.Additional information regarding the patient demographics has been requested, but has not yet been received.If additional information is received a supplemental report will be submitted.Csi id: (b)(4).
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Two hours after the completion of a procedure in which a viperwire guide wire was used, the patient presented with tamponade.The issue was determined to be due to a vessel perforation, which had been too small to be visible under fluoroscopy during the procedure.Pericardiocentesis was performed to treat the perforation, and as of (b)(6) 2020 the patient was in stable condition.In the opinion of the physician, the guide wire may have inadvertently advanced through a small distal vessel where the perforation occurred.
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