A review of the device history record, which includes verification of all steps in the manufacturing of the us catheter kit, verification of all final testing performed by/on the us catheter kit, and packaging for subject us catheter kit was performed.The review did not identify any non-conformances, issues or capas associated with us catheter kit function.Device was discarded and not returned for additional evaluation and investigation.Physician stated that the fracture may have been from their recent surgery but there is no way to be certain.Per the instructions for use of the device, catheter fracture is a known possible risk of use of the device.Internal complaint number: (b)(4).
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Representative reported that a catheter revision was performed due to a loss of pain control.It was reported that the patient recently had bladder surgery and was required to lay on their back in the lithotomy position.Since then, the patient had noted a loss of pain control.A dye study was then performed.It was reported that the dye study showed subdural migration of catheter tip.During the catheter revision surgery, no catheter migration was noted but a catheter fracture was observed around a previously revised section.Physician stated that the fracture may have been from their recent surgery but there is no way to be certain.The revised section was discarded.
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