Please note that this complaint was submitted to the fda by the user facility with the following reference number: mw5110205.The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
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The patient was undergoing a coil embolization procedure using a pod packing coil (pod pc), ruby coils, and a lantern delivery microcatheter (lantern).During the procedure, the physician placed ruby coils in the target vessel using the lantern.Next, while advancing a pod pc into the vessel, the coil became stuck after partially forming in the target location.Therefore, the physician decided to retract the pod pc to reposition the coil.However, while retracting, the pod pc unintentionally detached leaving a tail of the coil in the vessel.Subsequently, the physician attempted to use a snare device to remove the detached pod pc; however, while snaring the detached pod pc, the coil became unraveled.After several hours, the physician was able to successfully remove the unraveled pod pc using the snare device.The procedure was completed using a non-penumbra coil and the same lantern.There was no report of an adverse effect to the patient.
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