Model Number 4FC12 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Vascular System (Circulation), Impaired (2572); Pseudoaneurysm (2605)
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Event Date 02/24/2018 |
Event Type
Injury
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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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Event Description
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It was reported that post-operatively to a cryo ablation procedure, a pseudoaneurysm of the left groin was observed through sonography.Also, the patient experienced pain at the puncture site.A thrombin injection was administered.The hospital stay was extended.The case was completed with cryo.It was later that the patient was re-admitted to the hospital for pseudoaneurysm of the left groin again.The issue resolved the next day.This patient was a participant in the cryo af global registry clinical study.No further patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Event summary: the patient data files showed at least seven applications were performed with catheter 2af284/ 81446 without any issue on the date of the event.It was reported that post-operatively to a cryo ablation procedure, a pseudoaneurysm of the left groin was observed through sonography.The patient was re-admitted to the hospital for pseudoaneurysm of the left groin again.The issue resolved the next day.The patient experienced pain at the puncture site.The sheath was not returned for investigation.There is no indication that the reported adverse event is related to manufacturing.In conclusion, this is a case related to clinical adverse events (left groin pseudoaneurysm, pain).The reported issue was not related to the performance of the cryoablation devices.The sheath was not returned for investigation.If information is provided in the future, a supplemental report will be issued.
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Event Description
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(b)(6) 2018: upon further review, it should have been noted that the patient experienced pain at the puncture site.Additionally, the patient was apart of cryo af global registry clinical study.
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Search Alerts/Recalls
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