Manufacturer statement: for evaluation of the malfunction dhr documents were reviewed.They demonstrate that the catheter neurovent-p (sn (b)(4)) met specification during manufacturing.Final inspection of the finished catheter was passed.This demonstrates that the catheter has been manufactured and sold in conformance to relevant specifications.The sales representative who was around during implantation procedure confirm initial functionality of the catheter.Furthermore returned catheter was investigated.This investigation demonstrates that one wire is torn off.Based on knowledge above and in consideration of the results of performed investigation of returned catheter, the tear-off of the wire is caused by user error by stretching of the catheter during application contrary to ifu.This is in according with the description of the customer, that the loss of icp occurred during the transport to the icu after successful implantation in the operating room.
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