Corrected data: device was returned to manufacturer and was examined.Investigation - evaluation: a review of drawing, manufacturing instructions, specifications and quality control data was conducted during the investigation.A device history record review could not be performed as the complaint lot number was not provided.A visual examination of the returned sf-21-40 wire guide confirmed damage to the wire near the distal end.The distal weld connection separated at the mandrel wire and coil, resulting in coil elongation.There were no adverse effects to the patient due to this occurrence.A number of training certifications, manufacturing instructions, and quality instructions ensure that the parts are manufactured to specification.There is no evidence to indicate that the device was not manufactured to specification and this device is inspected 100% for bends, kinks, adequate joint strength, correct outside dimension and other surface imperfections prior to transport.We will continue to monitor for similar complaints.Based on the provided information a definitive root cause cannot be established or reported at this time.We will notify the appropriate personnel and continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
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