The implant coil and microcatheter were returned for analysis; the pusher was not returned.The implant coil was detached from the pusher, and noted to be compressed, stretched, and stuck inside the catheter.This condition can occur when the implant coil was stretched during the retraction process, and then pushing the device to move forward, compressing the coil.The catheter was noted to be kinked.The distal section of the implant coil was undamaged.Based on the investigation findings and available information, the reported complaint of a broken pusher was unable to be confirmed, as the pusher was not returned.The root cause of the complaint could not be determined without the missing components; however, the damage to the device returned and kinked catheter can increase the friction of the device and damage the implant or pusher during the procedure.This type of condition can occur when the device is subjected to excessive force during handling, if the microcatheter and implant coil were in a tortuous position, wrong manipulation or incorrect catheter position during the retraction process.
|