As reported (b)(6) 2014, a patient of unknown age and gender presented for an angiographic procedure.During prep for the procedure, when opening the sterile packaging, it was noted the tip of the catheter had fractured off inside of the package.The device was set aside, and a new of the same device was used to complete the procedure.The patient suffered no harm or injury due to the event.It was reported the device is available for return to the manufacturer for evaluation.
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It was reported that the device involved in the incident is available to be returned to the manufacturer for evaluation.To date the device has yet to be returned.Attempts are being made to obtain the device.An investigation into the root cause for incident is currently in progress.The results of the investigation will be sent via a follow up to 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.Complaint # (b)(4).
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