Description of Event or Problem · 1
PATIENT WAS UNDERGOING CARDIAC CATHERIZATION AND THE END OF THE CATHETER KINKED INSIDE THE HEART AND IT COULD NOT BE WITHDRAWN, THE PATIENT WAS IMMEDIATELY TAKEN TO THE OR WHERE OPEN HEART SURGERY WAS DONE TO EXTRACT THE CATHETER. THE PATIENT IS NOW IMPROVING AND IS SCHEDULED FOR DISCHARGE 2/7/92. THE CATHETER WAS VISUALLY EVALUATED AND IT WAS NOTED TO BE KINKED, CAUSE UNKNOWN. THE MANUFACTURER WILL CONDUCT FURTHER TESTS.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR 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: NONE OR UNKNOWN, OTHER, OTHER. CONCLUSION: DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT, DEVICE FAILURE RELATED TO PATIENT CONDITION, DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.