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It was reported that the wire guide of a turbo-flo single lumen over-the-wire picc set began to unravel as it was being removed.The picc component was inserted over the wire guide.When removing the wire guide, it began to unravel.Upon removal, the wire guide tip was noted to be in-tact.No adverse effects to the patient have been reported.
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Investigation ¿ evaluation: it was reported that the wire guide from a turbo-flo single lumen over-the-wire picc set (upics-501-mpis-otw) from lot 13387614 unraveled.This failure was noted after the catheter was advanced over the wire guide and when the wire guide was being withdrawn.Cook became aware of this event on (b)(6) 2020 upon being notified by (b)(6) hospital.The patient reportedly experienced no adverse effects as a result of this incident.A review of documentation including the complaint history, device history record, instructions for use (ifu), manufacturing instructions and quality control, as well as a visual inspection and dimensional verification of the returned device was conducted during the investigation.One used and damaged wire guide was returned for evaluation.The coil was fully separated from the solder, resulting in coil elongation in the majority of the coil.A small section of the coil at the distal end was not elongated.A small length of the mandril wire is intact within the section of coil.A dimensional verification of the outer diameter of the coil confirmed that it was manufactured within specification.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) found that sufficient controls are in place to detect this failure mode prior to release.A review of the design history file (dhf) found that the risks of this device were acceptable when weighed against the benefits.A review of the device history record (dhr) for lot 13387614 and related subassembly lot ic10085425 found no nonconformances that could have contributed to the reported failure mode.It should be noted that there were no other complaints associated with this lot.Since there are no related nonconformances or other complaints from this lot, there is no evidence that nonconforming product exists in house or in the field.The instructions for use (ifu), provides the following information related to the reported failure mode: precautions: standard techniques for placement of vascular access sheaths, angiographic catheters and wire guides should be employed.How supplied: upon removal from package, inspect the product to ensure no damage has occurred.Based on the information provided, examination of the returned product and the results of our investigation, it was concluded that the cause could be traced to a component failure unrelated to manufacturing or design deficiencies.It is possible that the wire guide was damaged by the sharp distal end of the needle and/or tortuous anatomy during introduction or advancement, but this cannot be confirmed without additional information.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.We will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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