A review of the manufacturing documentation confirmed that the lot met the specification requirements.The review found no deviations or non-conformances that would have contributed to the reported complaint.Taking into consideration the evaluation conducted and the details of the complaint, this investigation was assigned the most probable root cause of an anticipated procedural complication.A complaint with a most probable root cause classification of an anticipated procedural complication indicates that a device related root cause does not apply and the complaint is due to a known effect of the procedure.A secondary root cause of not confirmed is assigned as the most probable root cause classification with regards to the reported hole in the catheter.The complaint included a device review (visual, physical and/or performance testing) which showed no evidence of the alleged issue or any defect which could have contributed to the event.Product analysis did not confirm any leaks along the length of the catheter.
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