PORTEX MINI-TRACH LL CRICOTHYROIDOTOMY KIT

Additional Manufacturer Narrative

B3. DATE OF EVENT: UNKNOWN. NO INFORMATION HAS BEEN PROVIDED TO DATE. D4. PRIMARY UDI NUMBER: THE PRIMARY DI# HAS BEEN USED AS THE LOT/SERIAL INFORMATION IS UNKNOWN. H3. REASON DEVICE NOT EVALUATED BY MFG: OTHER; DEVICE WAS NOT RETURNED TO MANUFACTURER. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT HAD A HISTORY OF TOTAL THYROIDECTOMY FOR THYROID CANCER. A FOLLOW-UP CT (COMPUTED TOMOGRAPHY) SCAN REVEALED A SHADOW, SO A THORACOSCOPIC PARTIAL RESECTION OF THE RIGHT UPPER LOBE WAS PERFORMED, AND PRIMARY LUNG ADENOCARCINOMA WAS DIAGNOSED. THE DAY AFTER SURGERY, THE PATIENT COMPLAINED OF DIFFICULTY BREATHING. AS SPO2 DROPPED TO THE 60% RANGE, AN EMERGENCY BRONCHOSCOPY WAS PERFORMED, AND ASPHYXIATION DUE TO SPUTUM IMPROVED. HOWEVER, THE RIGHT MIDDLE AND LOWER LOBE BRONCHUS WAS BLOCKED BY SPUTUM, AND RIGHT LOWER LOBE PNEUMONIA WAS OBSERVED, SO A MINI-TRACH WAS INSERTED WITH THE ASSISTANCE OF A BRONCHOSCOPE. AS THE TRACHEA HAD BEEN REMOVED AFTER A TOTAL THYROIDECTOMY AND TENDED TO MOVE, PUNCTURE WAS DIFFICULT, AND DAMAGE WAS CAUSED TO THE LEFT SIDE OF THE MEMBRANOUS PORTION OF THE TRACHEA. AFTER PUNCTURE, LONGITUDINAL EMPHYSEMA AND AIR LEAKAGE FROM THE RIGHT CHEST DRAIN WERE OBSERVED. AFTER PATIENT TREATMENT, PROGRESS WAS OBSERVED, AND THE AIR LEAKAGE FROM THE DRAIN STOPPED THE DAY AFTER THE INJURY, AND THE DAMAGED PART OF THE MEMBRANOUS PORTION OF THE TRACHEA WAS NATURALLY CLOSED ON THE 5TH DAY AFTER THE INJURY, SO THE MINI-TRACH WAS REMOVED. THE MEMBRANOUS DAMAGE IMPROVED FURTHER ON THE 13TH DAY AFTER THE INJURY, AND THE PATIENT WAS DISCHARGED HOME ON THE 21ST DAY AFTER THE INJURY. THE PATIENT'S CONDITION HAS BEEN GOOD SINCE BEING DISCHARGED.

Additional Manufacturer Narrative

H6: EVALUATION CODES UPDATED. NO DEVICE WAS RECEIVED FOR INVESTIGATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE REPORTED COMPLAINT. IF WE RECEIVE THE DEVICE, WE WILL REOPEN THE INVESTIGATION FOR FURTHER EVALUATIONS. SERVICE HISTORY REVIEW IDENTIFIED THERE WAS NO INDICATION THAT THE COMPLAINT WAS RELATED TO A SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD.