The lot number for the reported malfunction was not provided, therefore a lot history review could not be performed.The device was not returned for evaluation, however medical records were provided for review.Based on the medical records, the investigation is confirmed for patient device interaction problem and malposition of the device.The definite root cause could not be determined cased on the available information.The device is labeled for single use.The catalog number identified has not been cleared in the us, but is similar to the meridian filter products that are cleared in the us.The pro code for the meridian filter products is identified.(b)(4).
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