The lot number for the malfunction is unknown, therefore the manufacturing review could not be conducted.The device for the malfunction has not been returned to the manufacturer for evaluation; however medical records have been received for evaluation.Review of the medical records confirmed malposition of the device, material deformation, and a patient-device interaction.Based upon 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 indicated that model ec500j vena cava filter allegedly experienced malposition of the device, material deformation, and a patient-device interaction problem.This information was received from one source.The malfunction involved one patient with no patient consequences.The weight of the (b)(6) year old female patient was not provided.
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