A review of the device history record, which includes verification of all steps in the manufacturing of the catheter kit, verification of sterilization, and packaging for subject catheter kit was performed.The review did not identify any non-conformances, issues or capas associated with catheter kit.Device was discarded and not returned for additional evaluation and investigation.As additional investigation could not be performed, a definitive root cause could not be determined for the alleged issue.Per the instructions for use of the device, catheter tears and breaks are known possible risks of use of the device.Internal complaint number: (b)(4).
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Agent reported that a patient's catheter and pump were replaced due to the catheter being unable to be aspirated during a dye study as well as underinfusion volume discrepancies being alleged.It was stated that the patient was experiencing a lack of spasticity relief.The physician was unsure if there were any issues with the patient's pump, but wanted to replace the pump as they were going to have surgery.During surgery, it was observed that there was a hole in the catheter.The devices were discarded.
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