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
No Consequences Or Impact To Patient (2199)
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Event Date 09/01/2020 |
Event Type
Injury
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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.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported dissection could not be determined.
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Event Description
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During an ablation procedure while going retrograde with the ablation catheter, the catheter would not advance, the artery was dissected, and the procedure was cancelled.The dissection was confirmed by angiogram.There were no patient symptoms and no intervention was performed.There were no performance issues with the abbott device.
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Search Alerts/Recalls
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