The lot number was not provided, therefore a lot history review could not be performed.The device was not returned for evaluation, however medical records were provided for review.The investigation is confirmed for the occlusion of the filter.The investigation is inconclusive for tilt and perforation.Based on the available information, the definitive root cause is unknown.The device is labeled for single use.
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This report summarizes one malfunction.A review of the reported information indicates that an unknown snf vena cava filter allegedly experienced obstruction within device, tilt, and perforation.The information is from one source.There was no reported patient injury.The patient is a (b)(6) year-old male, of (b)(6) lbs.
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