As the lot number for the device was not provided, a manufacturing review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
|
It was reported that during a first time intervention via an ipsilateral right common femoral approach to treat a very calcified iliac lesion for a patient with abnormal brachial index (abi), the balloon expandable vascular covered stent catheter was allegedly difficult to insert through a 6fr introducer sheath.However, the procedure was reportedly successfully completed with this device.There was no reported patient injury.
|