He reported event was confirmed manufacturing related.1 sample was confirmed to exhibit the reported failure.The device has not met specification.The product has caused the reported failure.Visual evaluation of the returned sample noted one opened (without original packaging), nitinol tipless skylite basket.Visual inspection of the sample noted the device was disassembled upon return.A potential root cause for this failure could be inadequate retention.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review was not performed because labeling could not have prevented the reported failure.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 evaluated.
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