According to the device history records, lot number osw-0202 was released following specifications, deviation dr0613 was recorded, but not related to the complaint.The angios from the case displayed the moment of embolization of the valve it was also confirmed by opsens's representative that pacing and thresholds were successfully tested before the beginning of the procedure.Opsens reached out the physician for comments regarding the incident and what might be the causes of the lost of capture, he believes that the grounding needle might have had intermittent connectivity issues which could explain why a few beats were missed and then paced again.The risks associated with the event are well documented and are disclosed in the savvywire instructions for use: "adverse events that may result from the use of this device include, but are not limited to: access site or vessels complications, additional surgical procedure, allergic reactions, amputation, aneurysm, angina, arrhythmia, bleeding, cardiac or vessel perforation/dissection, coronary obstruction, death, embolism, fibrillation, foreign body/wire fracture, heart block, hematoma, hypotension/hypertension, infection, kidney injury/failure, myocardial infarction, need for permanent pacemaker, pericardial effusion, pneumothorax, stroke or other neurologic event, spasm, tamponade, thrombus, valve dysfunction or complications, valve malpositioning or embolization, vasospasm, vessel occlusion, wire entrapment/entanglement, x-ray radiation exposure complications.".
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