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Patient 1
THIS INCIDENT REVOLVES AROUND A 35 YEAR OLD FEMALE WITH DIAGNOSIS OF METASTATIC ADENOCARCINOMA, WITH UNKNOWN PRIMARY SITE. IN 9/91 SHE UNDERWENT PLACEMENT OF A PORT-A-CATH. ON 12/13/91 A PORT-A-CATH STUDY REVEALED A LARGE THROMBUS AT THE CATHETER TIP. ON 2/24/92 ANOTHER FLOW STUDY REVEALED AN APPARENT BREAK IN THE SUBCLAVIAN CATHETERJUST BELOW THE CLAVICLE. ON 2/26/92 THE PORT AND THE PROXIMAL PORTION OF THE CATHETER WERE REMOVED. THE DISTAL PORTION WAS IN THE REGION OF SUPERIOR VENA CAVA AND WAS NOT REMOVED DUE TO PHYSCIAN DECISION THAT ANY BENEFITS WERE OUT WEIGHTED BY THE RISKS, DUE TO THE LIMITED LIFE EXPECTANCY OF THIS PATIENT. THE PATIENT EXPIRED ON 3/12/92 DUE TO ADVANCED MALIGNANCYDEVICE NOT 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 NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: NO. CORRECTIVE ACTIONS: USE OF ALL SIMILAR DEVICES STOPPED TEMPORARILY. THE DEVICE WAS DESTROYED/DISPOSED OF.