Evaluation / investigation: a visual inspection and functional testing of the returned device was conducted.A review of complaint history, the device history record, drawings, quality control data, and specifications was also performed.One unopened package was returned for investigation.A visual examination of the sealed package noted the basket formation appears kinked and pulled.The package was opened for investigation.The collet knob is tight and secure and the male luer lock adapter (mlla) is tight.There was no damage noted to the basket sheath.An observation of the basket formation noted that one of the wires is severely kinked.Upon the first actuation of the handle, two of the basket wires broke 5 mm from the knob.A review of the device history record found no non-conformances related to the reported failure mode.A review for additional complaints for this device lot found revealed this complaint to be the only complaint associated with lot number 8445982.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.Current controls for manufacturing are in place to assure functionality; device integrity prior to shipping.Based on the provided information a definitive root cause cannot be established.Per the quality engineering risk assessment, no further action is warranted.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.
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