Catalog Number UNK_NEU |
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 12/26/2019 |
Event Type
Injury
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Manufacturer Narrative
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The subject device is unavailable to manufacturer.
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Event Description
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It was reported that the bleeding at groin insertion occurred after the study procedure to 48 hours post procedure.According to the physician, the bleeding at groin insertion was related to the balloon guide catheter (subject device) and no serious adverse event reported and the event considered resolved on (b)(6) 2019.However, the additional information received on 24th feb 2020 stated that the patient passed away 14 days post procedure and related to index stroke.No other information was provided.
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Event Description
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It was reported that the bleeding at groin insertion occurred after the study procedure to 48 hours post procedure.According to the physician, the bleeding at groin insertion was related to the balloon guide catheter (subject device) and no serious adverse event reported and the event considered resolved on (b)(6) 2019.However, the additional information received on 24th feb 2020 stated that the patient passed away 14 days post procedure and related to index stroke.No other information was provided.
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Manufacturer Narrative
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Although the lot number was not provided, the automated manufacturing execution system (mes) has controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.The reported event is a known and anticipated complication to these types of procedures and patient condition and is listed as such in the device directions for use.Therefore, a cause of anticipated procedural complication was assigned to the reported event.
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Search Alerts/Recalls
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