Description of Event or Problem · 1
THIS WAS A TRIAL DEVICE BROUGHT BY COMPANY REP. THE BALLOON SYSTEM WAS PREPPED AS DESCRIBED BY MANUFACTURER. SYSTEM WAS ADVANCED INTO THE RIGHT CORONARY ARTERY AND ATTEMPT TO INFLATE WAS NOT SUCCESSFUL UNTIL 20 ATM. OF PRESSURE WAS APPLIED. DEFLATION OF BALLOON WAS NOT SUCCESSFUL. SYSTEM WAS REMOVED WITH BALLOON INFLATED. PATIENT SUFFERED WITH NO ILL EFFECTS. THE SYSTEM WAS RETURNED TO THE MANUFACTURER FOR FURTHER EVALUATION. ALTERNA SYSTEM USED TO COMPLETE PROCEDUREDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: DESIGN, TELEMETRY FAILURE, BALLOON. CONCLUSION: OTHER. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE, DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.