Model Number D2201 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Sepsis (2067)
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Event Date 11/05/2021 |
Event Type
Injury
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Event Description
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It was reported that following a water vapor therapy procedure, the patient developed a perivesical collection and ct scans identified signs of sepsis.The patient was hospitalized and will go under operation to drain the collection.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.
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Manufacturer Narrative
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Investigation summary: based on the information available, there was no device available for analysis and there was no report of a device performance allegation during treatment.The reported patient symptoms are a known risk associated with a water vapor therapy procedures and are noted as such in the device instructions for use.Device history record (dhr): a dhr and ship history review cannot be performed as the lot number of the device was not available.Device technical analysis: the device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Labeling review: the delivery device instructions for use (ifu) was reviewed.The patient symptom of sepsis was found to be listed in the ifu.Investigation conclusion: based on the information available, a conclusion code of known inherit risk of device was assigned to this investigation.
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Event Description
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It was reported that following a water vapor therapy procedure, the patient developed a perivesical collection and ct scans identified signs of sepsis.The patient was hospitalized and will go under operation to drain the collection.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.
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Search Alerts/Recalls
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