Of the nine devices, five lot numbers were provided and lot history reviews were performed.All the nine devices were not returned to the manufacturer for evaluation; however, medical records were provided for all malfunctions.For eight malfunctions, the investigations are confirmed for perforation of the inferior vena cava.For one malfunction, the investigation is confirmed for perforation of the inferior vena cava and unconfirmed for filter tilt.Based upon the available information, the definitive root cause is unknown.The devices are labeled for single use.Corporate lot no: gfsd2826, gfrh5437, unknown.
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This report summarizes nine malfunctions.A review of the reported information indicated that model rf320j vena cava filter allegedly experienced patient device interaction problem.This information was received from various sources.This malfunction involved all nine patients with no consequences.Nine patients' ages were reported to be between 44-77 years and one patients weight was (b)(6) kgs, two patients were reported as male, and six patients were reported as female.All other patient details were not provided.
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