As reported (b)(6) 2015, when unpacking the received device at the medical facility, it was noted the tip of the angiographic catheter was bent and appeared to be slightly fractured.As the defect was noted during unpacking, the reported device did not come into contact with a pt or a sterile medical setting.It was reported the disposable device us available for return to the mfr for eval.
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The reported defective device is available for return to the mfr for a device eval.To date the device has yet to be returned.Attempts are being made to obtain the device.An investigation into the root cause for event is currently in progress.A review of the lot history records was performed for the reported lot for any deviations.The review confirms that the lots met all material, assembly, and performance specs.The results of the device eval will be sent via a follow up medwatch.
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