The reported defective device has yet to be returned to the manufacturer for a device evaluation.The firm is attempting to obtain the device.An investigation into the root cause for product problem is currently in progress.The results of the device evaluation will be sent via a follow up medwatch.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 specifications.
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As reported, on (b)(6) 2015, a patient of unknown age and gender presented for an angiographic procedure.When opening the disposable device's sterile packaging during procedure prepping, it was noted the tip of the angiographic catheter had fractured off inside of the packaging.The disposable device was set aside and a new of the same device was used to successfully complete the procedure.There was no harm or injury to the patient due to the event as the device did not come into contact with the patient.It was reported the device is available for return to the manufacturer for evaluation.
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