A review of documentation, manufacturing instructions, specification and quality control data was conducted during the investigation.A 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.One used large dilator was returned.There is a noticeable spiral split in the material at the tip of the device.Measurements were taken of the outer diameter, inner diameter and end hole of the dilator and all measurements were found to be within specification.The customer stated that "the dilator looked a little bit curved at the tapered part and the end hole was a bit narrow." this is the second incident reported by this customer for this lot number.The other complaint is 1820334-2017-00548.However, although the end hole of the returned device was found to be on the low end of the specification, there is no indication or definitive evidence that the device was not manufactured to specification.The tip damage may have occurred after the customer tried to place the dilator over the guide wire.Based on the provided information, inspection of returned product and the investigation, 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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