ST. JUDE MEDICAL TACTICATH CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED BID CURVE D-F; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
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Model Number A-TCSE-DF |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Perforation of Esophagus (2399)
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Event Date 05/18/2021 |
Event Type
Injury
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Event Description
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Related manufacturing ref: 3008452825-2021-00357.Post atrial fibrillation ablation procedure, the patient presented with an atrio-oesophageal fistula and expired.During the procedure, prior to right sided pulmonary vein ablation, the first catheter was unable to zeroed.Another catheter of the same type was obtained; however, the physician was not confident in the contact force numbers.A fistula was noted adjacent to the right inferior pulmonary vein and the patient expired.
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Manufacturer Narrative
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The results of the investigation are inconclusive since the device was not returned for analysis; however, the log files from the tactisys quartz system were returned.The log file analysis concluded that the tacticath catheter performed as intended.The optical fibers met specifications, the recorded temperatures indicated cooling during rf ablation, and contact force measurements were displayed throughout the duration of the log files.The log files also indicated that the contact force was not reset according to the ensite contact force module instructions for use (ifu) and a ¿check baseline¿ error was displayed throughout the procedure.The ensite contact force module ifu warns ¿baseline drift of the force output may occur during the procedure.Operator should verify baseline integrity periodically during use.To check for baseline drift, position the catheter tip in a free-floating position away from the heart wall.In case of significant baseline drift (e.G.>5 g), a reset to zero should be applied by clicking the reset force button on the ensite¿ contact force module screen (when not ablating).¿ the ifu also states ¿baseline operation should be checked regularly and if necessary reset to zero, especially under the following circumstances: after the first insertion of the catheter into the body; after reinsertion into the patient¿s body after retraction through a sheath; when the message ¿please check baseline¿ displays.¿ however, due to unknown procedural conditions we are unable to conclusively determine the cause of the reported event.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported atrio-oesophageal fistula and subsequent patient death remains unknown.
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Event Description
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Post atrial fibrillation ablation procedure, the patient presented with an atrio-oesophageal fistula and expired.During the procedure, prior to right sided pulmonary vein ablation, the first catheter was unable to zeroed.Another catheter of the same type was obtained; however, the physician was not confident in the contact force numbers.Twenty one days post procedure, the patient presented with non specific neurological symptoms.A ct scan was performed but fistula was not diagnosed at this point and it is believed the patient subsequently had another 2 ct scans after the initial.The fistula was diagnosed on the 3rd scan days later by which point the patients symptoms included arm weakness and possible cerebral event.Surgical repair of a fistula adjacent to the right inferior pulmonary vein and the patient later passed away.
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Search Alerts/Recalls
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