Model Number HST III SEAL (4.5MM), 5-PACK |
Device Problem
Insufficient Information (3190)
|
Patient Problem
Hemorrhage/Bleeding (1888)
|
Event Date 10/24/2021 |
Event Type
Injury
|
Event Description
|
The hospital reported that during a coronary artery bypass procedure using hst iii seal (4.5mm).They used it as usual, but they couldn't stop bleeding.They opened a new one and was able to use it.There is no problem with the patient.
|
|
Manufacturer Narrative
|
Trackwise id # (b)(4).Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.
|
|
Manufacturer Narrative
|
Trackwise # (b)(4).Analysis of production: (3331/213/67) the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot number.Based on the dhr/lhr review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis: (4109/213/67) the review of the historical data indicates that no other similar complaints was reported for the same lot number and reported failure mode.Trend analysis: (4110/213/67) the overall 24 month product complaint trend data for the period (b)(6) 2019 through (b)(6) 2021 was reviewed.There were no triggers identified for the review period.Communication/interviews: (4111/213/67) communication/interviews were performed to obtain all possible information.
|
|
Event Description
|
N/a.
|
|
Search Alerts/Recalls
|