The product was disposed of by the hospital and is no longer available for return.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 hospital disposed of the device.
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The patient was undergoing a coil embolization procedure in the splenic artery using a pod packing coil (podj).During the procedure, the podj would not pack well or hold a pack.Therefore, the podj was removed and the procedure was completed using a new ruby coil.There was no report of an adverse effect to the patient.
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