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Blank fields on this form indicate the information is unknown or unavailable.E3 - occupation: director.G4 ¿ pma/510(k) #: exempt.This report includes information known at this time.A follow-up report will be submitted should additional, relevant information become available.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 or that a death or serious injury occurred; nor is it admission 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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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.This report includes information known at this time.A follow-up report will be submitted should additional, relevant information become available.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 or that a death or serious injury occurred; nor is it admission 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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Additional information was received.The device was required to treat a pneumothorax.It was confirmed that initially there were no difficulties advancing the wire guide.The patient started moving after partial advancement of the wire, so the advancement was paused.After the patient moved, the physician attempted to resume advancing the wire.However, it could no longer advance.An immediate attempt to remove the wire was made, and a significant amount of the wire was withdrawn.Then there was considerable resistance, and the wire could no longer advance or withdraw.At this point, the needle was removed and the wire broke.It was confirmed that the wire was manipulated or withdrawn through the needle.The patient did not have tortuous anatomy.
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Correction: d4-model#.Investigation ¿ evaluation: it was reported that the wire guide from a wayne pneumothorax tray separated during placement of a chest tube for a patient in the emergency department to treat a pneumothorax.It was confirmed that initially there were no difficulties advancing the wire guide.The patient started moving after partial advancement of the wire, so the advancement was paused.After the patient moved, the physician attempted to resume advancing the wire.However, it could no longer advance.An immediate attempt to remove the wire was made, and a significant amount of the wire was withdrawn.Then there was considerable resistance, and the wire could no longer advance or withdraw.At this point, the needle was removed and the wire broke.A small portion of the wire remains in the patient.No other adverse effects were reported for this event.The facility is investigated the incident with magnetic resonance imaging (mri) information.Reviews of the documentation, including the complaint history, device history record, quality control procedures, instructions for use (ifu), as well as visual inspection and dimensional verification of the returned product, were conducted during the investigation.Cook received one used wire guide for evaluation.A visual inspection of the wire found it to be stretched and elongated.The distal weld was not present.The outer diameter of the wire guide was measured and found to be within specification.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record (dhr) for the device found no relevant nonconformances that could have contributed to the reported failure mode.A search on the sub assembly lot found one related nonconformance which was scrapped.It should be noted that there were no other complaints associated with the final product lot number.Cook also reviewed product labeling: the instructions for use (ifu) [c_t_waynemod_rev5] includes the following: ¿instructions for use¿ 3.Insert the introducer needle through the incision into the pleural cavity.4.When the needle tip enters the pleural cavity, introduce the flexible end of the wire guide into the needle 10-15 cm.5.Remove the needle, leaving wire guide in place¿ 8.Advance the catheter over the wire guide into the pleural cavity to the desired depth.Depth may be guided by the 2.5 cm markings on the catheter.The first mark begins 5 cm from the last sidehole.9.Remove the wire guide and catheter obturator.Attach cook chest drain valve in direction indicated by arrow on valve¿¿ evidence gathered upon review of dmr, product labeling, dhr, and device failure analysis, does not indicate the device was manufactured out of specification.There is no evidence of nonconforming material in house or in the field.Based on the information provided, examination of the returned product, and the results of our investigation, cook has concluded that a failure to follow instructions contributed to the failure.It is possible that the wire was damaged by the sharp edge of the needle during manipulation and removal.Per the risk assessment no further action is required.The appropriate personnel have been notified.Cook 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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