The lot number was provided and a lot history review was completed.The device was not returned for evaluation, but medical records and images were provided and reviewed.The investigation confirmed for detachment of device or device component, patient device interaction problem, and obstruction; unconfirmed for migration of device or device component.A root cause could not be determined.The device is labeled for single use.(b)(4).
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This report summarizes one malfunction.The information reviewed indicated that model rf310f vena cava filter allegedly experienced migration of device or device component, obstruction, detachment of device or device component, and patient device interaction problem.This information was received from one source.The malfunction involved a patient with no reported consequences.The (b)(6) year old male patient's weight was not provided.
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