Catalog Number FST-002-00/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Stroke/CVA (1770)
|
Event Date 08/17/2023 |
Event Type
Injury
|
Event Description
|
The account alleges that after a pvi procedure where a steerable sheath was used, the patient had a minor stroke.There was no device deficiency reported.No additional information available.
|
|
Manufacturer Narrative
|
The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
|
|
Manufacturer Narrative
|
The suspect medical device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.Should the device be returned later, the investigation will be reopened.
|
|
Search Alerts/Recalls
|