Catalog Number SGC0302 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Fistula (1862); Hemorrhage/Bleeding (1888)
|
Event Date 09/29/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
|
|
Event Description
|
This is filed to report a hemorrhage and fistula.It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 3.The steerable guide catheter (sgc) was inserted, but during insertion, a spurting hemorrhage was observed.A fistula was then noticed between the femoral artery and the femoral vein.For safety reasons, the physician decided to discontinue the procedure.To treat the hemorrhage, protamine was administered, a pressure bandage was used, and the wound was stitched up.The physician stated that the injuries were suspected to be caused by the puncture of the femoral vein.However, the hemorrhage was worsened by the sgc.No clips were implanted, and mr remained at a grade of 3.There was no clinically significant delay in the procedure.No additional information was provided.
|
|
Manufacturer Narrative
|
The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on the information available, a definitive cause for the reported patient effect of fistula and hemorrhage could not be determined.The patient effects of fistula and hemorrhage, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.Although a conclusive cause for the reported patient effects and the relationship to the device, if any, cannot be determined, there is no indication of a product issue with respect to manufacture, design or labeling.Na.
|
|
Search Alerts/Recalls
|
|