Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Hematoma (1884); Hemorrhage/Bleeding (1888)
|
Event Date 12/03/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
|
|
Event Description
|
(b)(6).It was reported that following an ablation procedure with an intellanav stablepoint open-irrigated catheter, the patient experienced bleeding at the drain site.Pressure was applied and dressing was reinforced.The patient was placed in head of bed flat.The bleeding was resolved by administering an injection of lido/epi and silver nitrate.
|
|
Manufacturer Narrative
|
F.10 patient codes: corrected from hematoma e0505 to hemorrhage/bleeding e0506.It was indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.
|
|
Event Description
|
Newton af clinical study ae 2.It was reported that following an ablation procedure with an intellanav stablepoint open-irrigated catheter, the patient experienced bleeding at the drain site.Pressure was applied and dressing was reinforced.The patient was placed in head of bed flat.The bleeding was resolved by administering an injection of lido/epi and silver nitrate.
|
|
Manufacturer Narrative
|
Additional information was added to b5.It was indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.
|
|
Event Description
|
Newton af clinical study clinical study id: (b)(4), subject id: (b)(6).It was reported that following an ablation procedure with an intellanav stablepoint open-irrigated catheter, the patient experienced bleeding at the drain site.Pressure was applied and dressing was reinforced.The patient was placed in head of bed flat.The bleeding was resolved by administering an injection of lido/epi and silver nitrate.Additional information received indicates that the patient was discharged on (b)(6) 2021.
|
|
Search Alerts/Recalls
|