Pending additional follow up regarding causality of issue.A review of the device history record, which includes verification of all steps in the manufacturing of the catheter revision kit, verification of all final testing performed by/on the catheter revision kit, verification of sterilization, and packaging for subject catheter revision kit was performed.The review did not identify any non-conformance's, issues or capas associated with catheter revision kit function.Device was discarded and not returned for additional evaluation and investigation.Per the instructions for use of the device, catheter migration, kinking and fracturing are all known possible risks of use of the device.Internal complaint number: (b)(4).
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Clinical specialist (cs) contacted technical solutions to report a catheter revision.Initially, the patient was seen for a refill appointment where they reported unrelieved pain.An underinfusion volume discrepancy was observed with the expected volume being 0.0ml and the actual aspirated volume was 18.4ml.Days later, a catheter dye study was performed during which the physician was unable to aspirate csf.It was observed that the catheter tip had migrated out of the intrathecal space and had kinked.The patient's catheter was later revised.During the revision surgery, a catheter fracture was observed.The removed catheter portion was discarded.During the surgery, the patient's pump was reanchored as well.Please note that mfr 3010079947-2021-00237 will capture the pump revision.
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