Model Number DS-TV45X45-12F-080 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 10/22/2021 |
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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It was reported that on (b)(6) 2021, a 25mm amplatzer amulet left atrial appendage occluder was implanted using a 12f amplatzer amulet delivery sheath via the right femoral vein.Post-implant, right groin seepage was observed and elastic compression was applied.Then, femostop was also applied.Compression was continued until (b)(6) 2021 with successful stoppage of seepage.No patient consequences were reported.Clinical study patient id: (b)(6).
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Manufacturer Narrative
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An event of "post-implant, right groin seepage" was reported.A more comprehensive assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.
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Search Alerts/Recalls
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