The lot number for the reported malfunction was provided, therefore, a lot history review was performed.The device was not returned for evaluation.Medical records were provided and reviewed.Therefore, the investigation is confirmed for tilt, difficult to remove, perforation and material deformation.Based on the available information, the definitive root cause is unknown.The device is labeled for single use.
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A review of the reported information indicated that model rf310f vena cava filter experienced tilt, difficult to remove, perforation and material deformation.The information was received from a one source.This malfunction involved one patient with no patient consequences.The (b)(6) year old male patient was (b)(6).
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