As reported by a health care professional, during the procedure two presidio-18 coils (pc418103430/c32334 and pc418113730/c26955) failed to detach when being used with two enpower connecting cables (ecb00018200/ lot# c28985 and p10211).The procedure was the coil embolization of an un-ruptured aneurysm.The complaint coil 1 (pc418103430/c32334) was inserted but the coil could not be positioned properly, therefore, the coil was removed from the patient.The complaint coil 2 (pc418113730/c26955) was connected to the complaint cable (ecb00018200/c28985) for inserting the and detaching, however the power light did not illuminate.The coil and cable were reconnected several times but the coil could not be detached.The complaint coil 2 (pc418113730/c26955) was also connected the complaint cable (ecb00018200/p10211) but the power light did not illuminate.Therefore, this coil was also removed.Both the complaints coils were connected to both the complaint cables several times however the power light did not illuminate.Reportedly the detachment box was old (manufactured in 2010), and per the healthcare professional seemed to the problem but there was only one detachment box at the site and it could not be verified.The procedure was successfully completed without further issues or delay.There was also no patient injury / complication reported.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the ifu and the constant flush had been maintained at all time.No visible defect/damage was noted on the products prior to the event.The products are not available for the investigation.No further information is available.
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This is final mdr report being submitted for this complaint with associated mfr# 2954740-2017-00137 and 2954740-2017-00138.Based on the information, the event could not be confirmed.The presidio coil was not returned for analysis; however, a review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Therefore, no corrective actions will be taken at this time.There is no current safety signal identified related to the reported event based on review of complaint history for the device.
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