(b)(4).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.The device was implanted in the patient.
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The patient was undergoing a coil embolization procedure in the splenic artery using pod5 coils.During the procedure, the physician advanced a px slim delivery microcatheter (px slim) into the target vessel using other manufacturers'' sheath and microcatheter and then attempted to place a pod5 coil into the aneurysm.Although two-thirds of the pod5 coil was placed into the aneurysm, it was not deploying properly.After the physician retracted and advanced the pod5 coil several times in order to reposition the coil, it unintentionally detached.With two-thirds of the coil already in the aneurysm, the physician pushed the rest of the coil in using the pod5 coil pusher assembly.The procedure was then completed using another manufacturer's coils, a new pod coil and the same px slim.There was no report of an adverse effect to the patient.
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