Catalog Number M0035421020 |
Device Problem
Premature Separation (4045)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/15/2024 |
Event Type
malfunction
|
Event Description
|
It was reported that during the procedure the subject coil detached prematurely inside the microcatheter.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.No further information available.
|
|
Manufacturer Narrative
|
H3 other text : the device is not available to the manufacturer.
|
|
Manufacturer Narrative
|
H4 manufacturing date ¿ added.D4 expiration date - added.Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.Visual and functional inspections were not performed due to the device was not returned.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.While there are a number of potential causes for the reported issue, because review of available information failed to identify a definitive cause and the device was not returned for analysis, an assignable cause of undeterminable was assigned to the reported events: ¿main coil prematurely detached/separated during use' and 'main coil failed/unable to detach'.
|
|
Event Description
|
It was reported that during the procedure the subject coil detached prematurely inside the microcatheter.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.No further information available.
|
|
Search Alerts/Recalls
|