DRAGONFLY OPSTAR
Received Feb 23, 2021 · Event occurred Jan 25, 2021
Report 3009600098-2021-00009 · MDR key 11366183
Device
Generic name
Dragonfly Opstar Imaging Catheter
Manufacturer
Abbott VascularModel number
1014651Lot number
7540914
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Vasoconstriction
- Vasoconstriction
Narrative
Description of Event or Problem
DURING THE PROCEDURE, WHEN THE CATHETER WAS INSERTED ACROSS THE LESION, THE PATIENT EXPERIENCED A VASOSPASM THAT LED TO NO FLOW. THE CATHETER WAS REMOVED, NICARDIPINE WAS ADMINISTERED, AND THEY WAITED FOR THE VESSEL TO REGAIN FLOW. NO FURTHER OCT WAS PERFORMED. A GUIDEWIRE WAS USED TO MEASURE PRESSURE, BUT BECAME FLIMSY DURING DELIVERY. THE GUIDEWIRE WAS REPLACED AND THE PROCEDURE WAS COMPLETED. THE PATIENT WAS STABLE.
Additional Manufacturer Narrative
FURTHER INFORMATION WAS RECEIVED INDICATING THE LOT NUMBER WAS INCORRECT. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE AS THE LOT NUMBER IS UNKNOWN. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.