The integra dp valve was received without its proximal catheter, the distal catheter was received separately.Distal catheter was fractured at 2mm of the overmolding.The device history records of ref 901145, lot 0171776 and of the involved components (valve chamber outlet and distal catheter) were reviewed and did not reveal any anomaly that could explain the reported event.The distal catheter was extruded at integra neurosciences implants and manufacturing includes strength resistance testing: the distal catheter resists to 15 newtons and 600% of elongation.Device history records confirm resistance of the involved catheter component was within specifications.The complaint is verified, distal catheter is fractured.The exact root cause of the reported fracture after over 3 years of implantation could not be determined by the device investigation.
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