Description of Event or Problem · 1
ON 1 MAR 93 PATIENT BEGAN TO RUN AN ELEVATED TEMPERATURE.PATIENT WAS SENT TO RADIOLOGY FOR EXAM ON 3 MAR 93. EXAM REVEALED PART OF INSERTION SYSTEM STILL IN PATIENT. ON 10 MAR 93 PATIENT WAS TAKEN TO CATH LAB & PIECE WAS REMOVED. PATIENT SUFFERED NO INJURY FROM INCIDENT. PIECE REMOVED WAS DISTAL PORTION OF STYLET ROD (6 CM) WHICH RESIDES IN CARRIER CAPSULE. INVESTIGATION BEGUN 11 MAR 93. INVESTIGATION AND REVIEW CONCLUDED 31 MAR 93. IT WAS DETERMINED THAT THERE WAS NOTED NO DIFFICULTY INSERTING FILTER. REVIEW OF MEDICAL/SURGICAL REPORTS CONFIRM ROUTINE INSERTION. ALSO INTERVIEWED STAFF. CONCLUSION OF INVESTIGATION WAS THAT STYLE WAS MOST PROBABLY BROKEN INSIDE CARRIER. WAS KEPT IN PLACE BY FILTER DURING INSERTION, UPON WITHDRAWAL STYLET WORKED LOOSE FROM CARRIER AND WAS LEFT BEHINDINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. 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. INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. 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: OTHER. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: NONE OR UNKNOWN. THE DEVICE WAS DESTROYED/DISPOSED OF.