It was reported that coil break occurred.The patient underwent an embolization where the target lesion was located in a mildly tortuous varicocele.A 3mm/6mm vortx-35 coil was used for this treatment and was advanced all the way into the catheter.During procedure, the second pushable coil came out straight and rigid, it did not loop.Both ends of the coil were detached.The detached portion was not removed but remained implanted.The procedure was completed using an embolic glue.No complications were reported.
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It was reported that coil break occurred.The patient underwent an embolization where the target lesion was located in a mildly tortuous varicocele.A 3mm/6mm vortx-35 coil was used for this treatment and was advanced all the way into the catheter.During procedure, the second pushable coil came out straight and rigid, it did not loop.Both ends of the coil were detached.The detached portion was not removed but remained implanted.The procedure was completed using an embolic glue.No complications were reported.
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Device evaluated by mfr.: device was not returned, but pictures attached to the complaint show no broken sections, and that it is possible to observe two coils periph where the main coils were bent at the primary coil and stretched at the zap tips sections.However, based on the time event the device, was not damaged before entering the patient, therefore the most likely cause of the reported problem cannot be established due to the lack of testing, so without a proper evaluation of the device, the most likely causes that contributed to the event are unknown.
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