GUIDEWIRE
Received Apr 6, 2020 · Event occurred Mar 13, 2020
Report 2017865-2020-04661 · MDR key 9927846
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
60 YR
- Vascular Dissection
- Vascular Dissection
Narrative
Additional Manufacturer Narrative
THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED.
Description of Event or Problem
IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE GUIDEWIRE DISSECTED THE PATIENT'S CORONARY SINUS. THERE WAS NO LEAD MOUNTED ON THE GUIDEWIRE WHEN DISSECTION OCCURRED. THE PROCEDURE WAS COMPLETED WITHOUT EMERGENCY INTERVENTION. THE PATIENT WAS WELL POST-PROCEDURE.
Additional Manufacturer Narrative
IT WAS PREVIOUSLY REPORTED THAT NO INTERVENTION REQUIRED, HOWEVER CORONARY SINUS CANUATION WAS PERFORMED.
Description of Event or Problem
IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE GUIDEWIRE DISSECTED THE PATIENT'S CORONARY SINUS. THERE WAS NO LEAD MOUNTED ON THE GUIDEWIRE WHEN DISSECTION OCCURRED. THE PROCEDURE WAS COMPLETED AFTER CANULATION OF THE CORONARY SINUS. THE PATIENT WAS WELL POST-PROCEDURE.