Model Number N/A |
Device Problems
Inflation Problem (1310); Gas/Air Leak (2946)
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Patient Problem
Blood Loss (2597)
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Event Date 03/06/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device was not returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.A review of the device history record of the product code/lot# combination was conducted with no findings.
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Event Description
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The user facility reported that the tr band was losing air during the procedure.The patient was stable and the procedure outcome was successful.Additional information was received on 31mar2020.The procedure being performed was a left heart catheterization.The tr band was inflated to 12ml to start and then increased to 18ml.The one-way valve seemed to be leaking air out once the syringe was put in and air added the valve quit leaking.The estimated blood loss was 250cc.Hemostasis was achieved by the tr band.
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Manufacturer Narrative
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This report is being submitted as follow up no.1 to provide the completed investigation results.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.With no return of the actual device, the exact cause of the reported event cannot be definitively determined based on the available information.
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Search Alerts/Recalls
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