Model Number 1014652 |
Device Problem
No Display/Image (1183)
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Patient Problem
Ventricular Fibrillation (2130)
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Event Date 10/17/2021 |
Event Type
Injury
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Event Description
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During an emergency procedure for acute coronary syndrome, the patient experienced ventricular fibrillation.The dragonfly opstar catheters were used in the left circumflex artery#11-13 lesion with tortuosity and moderate stenosis.After the guidewire was crossed into the lesion, thrombus was removed and then the first catheter was delivered to the lesion.While delivering the catheter into the left circumflex artery lesion, the middle of the device bent but the catheter was passed through by pushing the shaft firmly.The live view was selected, however, the in vivo image did not appear.The second catheter was used and it passed through the lesion successfully.When purging the coronary artery with contrast for oct imaging, ventricular fibrillation occurred and the catheter was removed from the patient.Defibrillation was applied and the sinus rhythm returned to normal.The catheter was advanced into the lesion again, and before a pullback, the in vivo image did not appear.A third catheter was used to complete the procedure and the patient was stable.
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Event Description
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During an emergency procedure for acute coronary syndrome, the patient experienced ventricular fibrillation.The dragonfly opstar catheters were used in the left circumflex artery#11-13 lesion with tortuosity and moderate stenosis.After the guidewire was crossed into the lesion, thrombus was removed and then the first catheter was delivered to the lesion.While delivering the catheter into the left circumflex artery lesion, the middle of the device bent but the catheter was passed through by pushing the shaft firmly.The live view was selected, however, the in vivo image did not appear.The second catheter was used and it passed through the lesion successfully.When purging the coronary artery with contrast for oct imaging, ventricular fibrillation occurred and the catheter was removed from the patient.Defibrillation was applied and the sinus rhythm returned to normal.The catheter was advanced into the lesion again, and before a pullback, the in vivo image did not appear.A third catheter was used to complete the procedure and the patient was stable.
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Manufacturer Narrative
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The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.
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Search Alerts/Recalls
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