Model Number PRODUCT NOT IN LIST - BEATING HEART |
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 Type
Injury
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Manufacturer Narrative
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Trackwise id: (b)(4).Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.Device discarded.
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Event Description
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The hospital reported through heartstring iii advisory panel event about the heartstring iii used for a coronary artery bypass procedure.They mentioned "lately they have been seeing more blood" when using the hs iii system.¿occasionally, but infrequently¿, he feels the seal does not create as good of a hemostatic field as he is used to seeing.He noted this has been occurring ¿maybe in the past 5 years¿ he feels it was less of a problem prior to maybe 5 years ago.He has noted this issue to be related to the level of aortic atherosclerotic disease.Nor has he noted that the patient¿s blood pressure was lower than what he prefers it to be during creation of the proximal anastomosis.He noted ¿it is really not a big deal and does not interfere with his ability to perform the anastomosis¿ but is different than what he remembers comparing use now to 5 years ago.
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Manufacturer Narrative
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Trackwise # (b)(4).Corrected section; b5 - event description corrected.Communication/interviews: (4111/213/67) communication/interviews were performed to obtain all possible information.Trend analysis: (4110/213/67) the overall 24 month product complaint trend data for the period mar-2020 through feb-2022 was reviewed.There were no triggers identified for the review period.
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Event Description
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Statement from the heartstring iii advisory panel event about the heartstring iii used for a coronary artery bypass procedure.They mentioned "lately they have been seeing more blood" when using the hs iii system.¿occasionally, but infrequently¿, he feels the seal does not create as good of a hemostatic field as he is used to seeing.He noted this has been occurring ¿maybe in the past 5 years¿ he feels it was less of a problem prior to maybe 5 years ago.He has noted this issue to be related to the level of aortic atherosclerotic disease.Nor has he noted that the patient¿s blood pressure was lower than what he prefers it to be during creation of the proximal anastomosis.He noted ¿it is really not a big deal and does not interfere with his ability to perform the anastomosis¿ but is different than what he remembers comparing use now to 5 years ago.
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Search Alerts/Recalls
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