The electronic device history record (edhr) review confirms that the device met all material, assembly and performance specifications.During visual inspection, the delivery wire was noted to be kinked.During functional testing, the coil in catheter test was performed using the sl-10 microcatheter that was returned for this complaint.Friction was encountered when advancing the coil through the catheter.In case of this complaint, it is most likely that friction between the target coil and the sl-10 microcatheter was met due to the catheter being kinked/bent.The catheter was kinked most likely due to some procedural factors encountered during use.In this case, it was also reported that the target coil and the sl-10 microcatheter perforated the aneurysm.It is likely that the catheter together with the coil erratically moved while the physician was pushing the coil against friction, causing the reported aneurysm rupture; however, this cannot be conclusively determined.The reported aneurysm rupture is a known anticipated complication to this type of procedures and patient condition and is listed as such in the device direction for use; therefore, a probable cause of anticipated procedural complication was assigned to the as reported issue aneurysm rupture.
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