It was reported that a retracta detachable embolization coil unraveled.During an embolization procedure, the coil would not detach and unraveled.Subsequently, the entire coil and the catheter were removed from the patient.It was confirmed that no part of the device was retained in the patient.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: b5 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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Investigation / evaluation: it was reported that a retracta detachable embolization coil would not detach during an embolization procedure, and the coil unraveled.Subsequently, the entire coil and the catheter were removed from the patient.The junction zone was said to be just out of the end of the catheter at the time of attempted deployment.It was confirmed that no part of the device was retained in the patient.There were no adverse effects or additional procedures reported for the patient due to this occurrence.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), and quality control procedures, as well as a visual inspection of the returned device, were conducted during the investigation.Cook received one device (coil only) in a used and damaged condition.Upon visual inspection it was noted the coil was stretched and elongated.Additionally, a document-based investigation evaluation was performed.In response to this incident, cook completed a review of the product device master record (dmr) and concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Cook also reviewed the dhr for the reported lot and records no relevant non-conformance's.A database search for complaints on the reported lot found no additional complaints reported from the field.Cook concluded that no nonconforming product from this lot exists in house or in the field.Cook also reviewed product labeling.The current instructions for use [t_mwcer_rev6] state the following: "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." the information provided upon review of the dmr, dhr, and ifu 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, 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.It was stated the user had the junction zone of the delivery wire just outside of the catheter, as opposed to just inside as stated in the instructions for use.This possibly led to the reported event, but this could not be definitively confirmed.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.
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