G9: exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents from this lot.The investigation determined the reported difficulties appears to be related to circumstances of the procedure as it is likely that the cap seal was not entirely opened; thus resulting in the reported difficulty to insert and the reported irregular appearance (inlet of y-valve was narrow).The reported delayed therapy/non-surgical treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.
|
It was reported that the patient presented with a myocardial infarction and the procedure was performed to treat a lesion in the left anterior descending coronary artery with moderate calcification.An unspecified guide wire was inserted through a copilot bleed back control valve without issue.On attempting to advance an unspecified balloon catheter through the copilot, resistance was met and the inlet of the copilot was noted to be narrow.A new copilot bleed back control valve was used to successfully continue the procedure; however, the event prolonged the operation time and radiation exposure to the patient.The final patient outcome was reported to be satisfactory.No additional information was provided.
|