The reported event was confirmed and the cause was unknown.A potential root cause for the reported event could be, inappropriate package design".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "improper handling technique can seriously weaken the stent." "exercise care.Tearing of the stent can be caused by sharp instruments." "care should be exercised when removing the stent from inner polybag so as not to cause tearing or fragmentation." h11: section a through f - 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.H3 other text: the actual/suspected device was inspected.
|