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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR DRAGONFLY OPSTAR¿; DRAGONFLY OPSTAR IMAGING CATHETER
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ABBOTT VASCULAR DRAGONFLY OPSTAR¿; DRAGONFLY OPSTAR IMAGING CATHETER Back to Search Results
Model Number 1014652
Device Problem No Display/Image (1183)
Patient Problem Ventricular Fibrillation (2130)
Event Date 10/17/2021
Event Type  Injury  
Event Description
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.
 
Event Description
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.
 
Manufacturer Narrative
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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Brand Name
DRAGONFLY OPSTAR¿
Type of Device
DRAGONFLY OPSTAR IMAGING CATHETER
Manufacturer (Section D)
ABBOTT VASCULAR
4 robbins drive
westford MA 01886
Manufacturer (Section G)
ABBOTT VASCULAR
4 robbins drive
westford MA 01886
Manufacturer Contact
lindsey bell
26531 ynez rd.
temecula, CA 92591
9519143996
MDR Report Key12820084
MDR Text Key285329845
Report Number3009600098-2021-00020
Device Sequence Number1
Product Code DQO
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K192019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date04/14/2022
Device Model Number1014652
Device Lot Number7925073
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/19/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/14/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age78 YR
Patient SexFemale
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