Of the 2 devices, lot numbers were not provided.
The lot history reviews could not be performed.
Of the 2 reported malfunctions, devices were not returned for evaluation; however, medical records were provided for both malfunctions.
For both malfunctions, the investigation is confirmed for migration and patient device interaction problem; however, the investigation is unconfirmed malposition of device for one malfunction.
Based upon the available information, the definitive root cause is unknown.
The devices were labeled for single use.
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This report summarizes two malfunctions.
A review of the reported information indicates that model unknown filter vena cava filter allegedly experienced migration and patient device interaction problem.
The information was received from various sources.
Of the two malfunctions, both involved patients with no patient consequences.
Two female¿s ages were reported ranging from 40 to 48; however, the weights were not reported for both patients.
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