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It was reported that the wire guide of a fuhrman pleural/pneumopericardial drainage tray frayed after chest tube insertion.The wire guide was unable to be removed smoothly.Upon removal, it was noted to be frayed and beginning to break.No adverse effects to the patient have been reported.Additional information regarding the patient, device, and event has been requested but is currently unavailable.
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Correction: h6 ¿ patient code: no consequences or impact to patient (b)(6).Investigation ¿ evaluation: it was reported that a wire guide from a fuhrman pleural/pneumopericardial drainage tray (c-ppdy-850-imh) from lot 10308662 broke and frayed.The wire guide became stuck within the patient and was not removed smoothly.No difficult advancement was noted.The fraying was noted upon removal.Cook became aware of this event on 03nov2020 upon being notified by providence everett medical center.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, quality control and specifications, as well as a visual inspection and dimensional verification of the returned device was conducted during the investigation.One wire guide was received for evaluation in used and damaged condition.The inner solder between the mandril and safety wire was broken.The mandril was found to be protruding from the coil towards the distal end.The outer diameter was measured and confirmed to be 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 are acceptable when weighed against the benefits.A review of the device history record (dhr) for lot 10308662 found no relevant nonconformances that could have contributed to the reported failure mode.Nonconformances were found in the wire guide subassembly lot (ic10216559), in which two devices were scrapped due to separated coils and another was scrapped for an insufficient solder.An additional nonconformance was found in the wire guide subassembly lot (ic10216561), in which one device was scrapped due to damaged coils at the curve.It should be noted that there were no additional complaints associated with this lot.All nonconforming devices were scrapped, and all remaining devices in the lot underwent quality control activities such as tensile tests for weld security and visual inspection or damage.Since these 100% inspection procedures are in place and no other complaints have originated from this lot or related lots, 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: warnings: the wire guide should always advance without impedance to avoid perforation of any surrounding structures.The wire guide should always extend beyond the catheter tip to avoid perforation of any surrounding structures.Based on the information provided, examination of the returned product and the results of our investigation, it was concluded that a component failure unrelated to manufacturing or design deficiency contributed to the event.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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