(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The customer reported the device was discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional trek device referenced is being filed under a separate medwatch report.
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Internal file number (b)(4).Unique device identifier (udi#): in the absence of a reported part number, the udi cannot be calculated.The device was not returned for evaluation.It was reported that the missing size stamp was not noted after the successful use of the device in the patient anatomy.It should be noted that the coronary dilatation catheters (cdc), nc trek rx, global instructions for use, states: prior to angioplasty, the dilatation catheter should be examined to verify functionality and ensure that its size is suitable for the specific procedure for which it is to be used.A review of the lot history record and complaint history could not be conducted because the part and lot numbers were not provided.The investigation determined the reported device marking issue appears to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.
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