Investigation - evaluation: device was returned for the evaluation.A visual examination discovered the distal weld connection has separated from the safety wire, resulting in coil elongation and wire protrusion.Approximately 7mm of the coil located at the distal end was not elongated.The overall length of the coil that did exhibit coil elongation measured approximately 133.5 cm.Although damage to the wire was confirmed, both weld connections were intact, indicating that no material was left within the patient.It was concluded that the device had been subjected to force beyond its intended design.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.In addition, the review of device history record did not observe any nonconformance that may have contributed to this incident.A complaint history review showed this complaint to be the only one associated with the complaint lot number.Based on the provided information a definitive root cause cannot be established or reported at this time.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.Per the risk assessment no further action is required.
|