The provided video confirmed the report.It shows leakage from both the blue balloon and safety balloon.The product was not returned; therefore, a root cause could not be conclusively determined.The lot history record for the device was reviewed, no issues were found during manufacturing or packaging that would cause or contribute to the reported event.We have not received any similar complaints related to this lot number.Note: this is report 2 of 4 related to the second catheter used in the event.Reports 1220948-2023-00107, 1220948-2023-00109, 1220948-2023-00110 were submitted for the first, third, and fourth devices involved in this event.
|
It was reported 4 pruitt f3 carotid shunt leaked during water test.There were no patient involvement.Note: this is report 2 of 4 related to the second catheter used in the event.Reports 1220948-2023-00107, 1220948-2023-00109, 1220948-2023-00110 were submitted for the first, third, and fourth devices involved in this event.
|