There are controls in the manufacturing process to ensure the product met specifications upon release.The product was not returned.A swirl/sliver of ptfe (polytetrafluoroethylene) coating was returned wrapped inside medical gauze.Upon inspection, it was determined that the ptfe (polytetrafluoroethylene) coating belonged to the guidewire investigated under same parent complaint.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.Additional information provided by the customer indicated that the device was confirmed to be in good condition during preparation/prior to use on the patient and was prepared as per the dfu, the dispenser hoop was flushed and there was no friction or resistance while removing the catheter from the dispenser hoop, the introducer was used when inserting the guidewire into the catheter, and flush was given inside the catheter when inserting the guidewire.The device was not returned for analysis as it was discarded at the hospital; however, a swirl/sliver of the coating substance described in the event description was returned wrapped inside medical gauze.Upon inspection, it was determined that this substance was ptfe coating likely belonging to the guidewire investigated under the same parent complaint.As this coating was ptfe (polytetrafluoroethylene) and not hydrophilic, the as reported 'hydrophilic coating peeling' was not confirmed.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.
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