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 in the gastroduodenal artery (gda) using ruby coils and non-penumbra microcatheter.It was noted that the patient¿s anatomy was tortuous.During the procedure, while advancing a ruby coil into the target location, the physician lost access with the microcatheter.Subsequently, the hospital technician attempted to re-sheath the ruby coil; however, the ruby coil could not be retracted back into the its introducer sheath.Therefore, the ruby coil was removed.The procedure was completed using a new ruby coil, a pod packing coil (pod pc), and the same microcatheter.There was no report of an adverse effect to the patient.
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