As reported (b)(6) 2014, a pt of unk age and gender presented for an angiographic procedure.When opening the disposable device's sterile packaging while prepping for the procedure, 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 pt due to the event as the device did not come into contact with the pt.It was reported the disposable device is 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 any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly, and performance specifications.The results of the device eval will be sent via a follow up medwatch.Complaint # (b)(4).
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