ST. JUDE MEDICAL SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL0, 63 CM LENGTH, 8.5 F; INTRODUCER, CATHETER
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Model Number 407451 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Cardiac Perforation (2513)
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Event Date 12/04/2020 |
Event Type
Injury
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Manufacturer Narrative
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The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
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Event Description
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Related manufacturing ref: 3008452825-2020-0723, 3008452825-2020-00724, 3008452825-2020-00725, 3008452825-2020-00726.Two days post atrial fibrillation ablation procedure, a pericardial effusion was noted via transthoracic echocardiography.Serohematic fluid was drained which stabilized the patient.There were no performance issues with any abbott devices.
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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 perforation remains unknown.Per the ifu, cardiac perforation is a known risk during the use of this device.
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Search Alerts/Recalls
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