Model Number N/A |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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Date of event: potential date of event (b)(6) 2019.Expiration date - unknown due to lot number being unknown.Udi - unknown due to lot number being unknown.Implanted date: device was not implanted.Explanted date: device was not explanted.Device manufacture date - unknown due to lot number being unknown.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.The production lot number was not provided by the user facility, which prevented a meaningful review of the device history record and complaint files.
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Event Description
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The user facility reported that they inflated a tr band and noticed the balloon deflated upon removing the syringe.The tr band was removed and a second tr band was placed with no issue.The patient was in stable condition.The procedure outcome was completed successfully.Additional information was received june 19, 2019: it was reported that there was no blood loss.The procedure was a left heart catheterization with no intervention.
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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 evaluation of the actual device could not be conducted due to the device not being returned.With no device return, 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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