The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.
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Visual evaluation observed that the stent suture was broken and also noted that the stent was broken in the first eyelet located at bladder end, the remainder piece was return with the sample.The stent presented stress marks and it was received out of its individual sealed polybag.The dimensional evaluation found the stent to be within specification.The reported event was confirmed with the cause unknown.The device history record was reviewed and found nothing that could have cause or contributed to the reported event.The instructions for use states the following: "improper handling technique can seriously weaken the stent.Acute bending or overstressing during placement could result in subsequent separation of the stent at the point of stress after a prolonged indwelling period.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." (b)(4).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.
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