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Model Number 4FC12 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Anemia (1706); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Vaso-Vagal Response (2661)
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Event Date 04/05/2017 |
Event Type
Injury
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Manufacturer Narrative
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A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that during a cryo ablation procedure, aspiration might have been performed too much during insertion and retraction of the catheter to and from the sheath.It was suspected that anemia, which started to develop due to too much aspiration, was accompanied with bleeding from the puncture site as well as vagal reflex.It took a long time for hemostasis because the amount of bleeding from the puncture site was more significant than expected.Furthermore, cardiac tamponade was suspected but echocardiography was performed and no pericardial effusion was confirmed.Wild fluctuations in blood pressure were also observed while moving the patient from the catheterization table to the bed (dropped).Also, a ct scan was performed after the procedure and no injuries or abnormalities were observed in the retroperitoneum.Thus, transfusion was not required.The case was completed with cryo.The patient¿s hospital stay was extended.No further patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Product event summary: the data files were returned and analyzed.The data files showed that multiple injections were performed without any issue.The sheath was not returned for investigation.A known clinical issue was encountered during the procedure (hypotension, anemia, vagal, bleed).
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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