(b)(4).The results of the investigation are inconclusive since the device was not returned for analysis.A review of the device history record was not possible since the batch number was unavailable.Based on the information received, the cause of the reported blood loss could not be conclusively determined.Per the ifu, bleeding may occur as a result of the delivery of electrical energy during internal defibrillation or at the catheter introducer site.
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Following an atrial fibrillation procedure, a retroperitoneal bleed was noted.During the procedure, the patient experienced lower abdominal and upper groin pain post procedure.An x-ray revealed a retroperitoneal bleed with no intervention performed.The patient was observed to ensure that the bleed had stopped and the patient stabilized.
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