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It was reported that the nester platinum embolization microcoil was difficult to advance during a sigmoid artery embolization procedure on an 80-year-old female patient.The target vessel was a branch of the sigmoid artery with a diameter of less then 2 millimeters.The catheter was flushed and the pusher stylet was advanced through the shipping cartridge with ease.The coil was indwelling for 10-15 seconds before it was advanced into a cook cantata micro catheter using a cook coil pusher.Difficulty was experienced when advancing along some tortuosity, so the flush technique was used to deploy the coil.It did not deploy fully, so once again the coil pusher was used to deploy.However, the coil got stuck to the coil pusher and was withdrawn back into the catheter.The coil was removed using the micro catheter.The coil appeared to be compressed upon a visual examination.The procedure was completed using another cook coil.The coils that were deployed without issue remained in the target area.The user reported that no damage was noted to the device when the package was opened.It was confirmed that the catheter was flushed prior to each coil deployment.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
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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, unchanged or unavailable.Correction: d4 - model # investigation ¿ evaluation on (b)(6) 2024, it was reported that the nester platinum embolization microcoil was difficult to advance during a sigmoid artery embolization procedure on an (b)(6) -year-old female patient.The target vessel was a branch of the sigmoid artery with a diameter of less than 2 millimeters.The catheter was flushed, and the pusher stylet was advanced through the shipping cartridge with ease.The coil was indwelling for 10-15 seconds before it was advanced into a cook cantata micro catheter using a cook coil pusher.Difficulty was experienced when advancing along some tortuosity, so the flush technique was used to deploy the coil.It did not deploy fully, so once again the coil pusher was used to deploy.However, the coil got stuck to the coil pusher and was withdrawn back into the catheter.The coil was removed using the micro catheter.The coil did not exit the microcatheter fully.Approximately 1 cm of the coil remained in the catheter.The clinician was not able to deploy the coil completely.When the clinician withdrew the wire, the coil pulled back into the catheter at the same time.The clinician removed the catheter and coil together.The coil appeared to be compressed upon a visual examination.The procedure was completed using another cook coil.The coils that were deployed without issue remained in the target area.The user reported that no damage was noted to the device when the package was opened.It was confirmed that the catheter was flushed prior to each coil deployment.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Reviews of the documentation, including the complaint history, device history record, quality control procedures and instructions for use of the device, were conducted during the investigation.The complaint device was not returned for evaluation; therefore, a physical examination could not be conducted.However, 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 relevant nonconformances that could have contributed to the reported failure mode, in which all affected product was scrapped prior to further processing.It should be noted that there were no other complaints associated with the final product lot number.Cook also reviewed product labeling: the current instructions for use [t_ce_nec_rev4] state the following: "warnings if difficulties occur when deploying the embolization coil, withdraw the wire guide, coil and angiographic catheter simultaneously as a unit." evidence gathered upon review of the dmr, ifu, and the dhr suggests that the device was not manufactured out of specification, and that there are no nonconforming devices in house or out in the field.Based on the information provided, no product retuned, and the results of our investigation, it was concluded that a component failure unrelated to manufacturing or design deficiencies contributed to the reported event.It is possible that the coil passed through a portion of the catheter that the flushing process missed, not allowing the coil to smoothly transition through the catheter and into the patient, but this cannot be definitively confirmed.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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