Blank fields on this form indicate the information is unknown or unavailable.E1 - customer (person): phone: (b)(6).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.
|
It was reported that a retracta detachable embolization coil would not detach.During a renal artery aneurysm embolization procedure, the coil did not deploy.The device was subsequently removed from the patient.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
|
In additional information received on 26oct2023, it was reported that the procedure was completed per angiography.It was confirmed that the catheter was flushed, and the junction zone was half in and half out of the catheter, prior to coil deployment.The coil was rotated eight times counterclockwise.
|
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation.It was reported that a retracta detachable embolization coil would not detach.During a renal artery aneurysm embolization procedure, the coil did not deploy.The device was subsequently removed from the patient.It was reported that the procedure was completed per angiography.It was confirmed that the catheter was flushed, and the junction zone was half in and half out of the catheter, prior to coil deployment.The coil was rotated eight times counterclockwise.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Reviews of documentation including the complaint history, device history record (dhr), quality control procedures, and instructions for use (ifu), as well as a visual inspection of the returned device, were conducted during the investigation.One used device (delivery wire and coil) was returned to cook for evaluation.Upon visual inspection, it was noted that the coil was stretched and elongated and separated from the wire.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 dhrs for the reported complaint device lot and the related subassembly lots revealed no relevant non-conformances.A database search did not identify any additional complaints associated with the reported device lot.Based on the available information, cook has concluded that the device was manufactured to specification and that there is no evidence suggesting nonconforming product exists either in house or in the field.Cook also reviewed product labeling.The ifu [t_mwcer_rev6] packaged with the device contains the following in relation to the reported failure mode: "under fluoroscopic visualization, slowly advance the delivery wire until the entire length of coil exits the distal end of the catheter.Ensure that the junction remains positioned just inside the catheter tip.Note: advancing the delivery wire slowly allows the junction to be seen more easily and reduces the risk of damaging it.Note: if significant resistance is encountered during coil advancement, do not continue advancing.Retract the delivery wire slightly, then gently re-advance it.If there is still significant resistance, withdraw the delivery wire from the catheter and try using a new coil with a shorter length." based on the information provided, inspection of the returned device, and the results of the investigation, cook has concluded that component failure unrelated to manufacturing or design deficiencies contributed to this incident.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment no further action is required.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.
|