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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRAGONFLY OPSTAR¿; DRAGONFLY OPSTAR IMAGING CATHETER

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DRAGONFLY OPSTAR¿; DRAGONFLY OPSTAR IMAGING CATHETER Back to Search Results
Model Number 1014652
Device Problem Gas/Air Leak (2946)
Patient Problem Air Embolism (1697)
Event Date 01/22/2021
Event Type  Injury  
Event Description
During the procedure, when the catheter was inserted into the left circumflex artery lesion, air entered and caused peripheral embolization and vital changes in the patient.No pullback had been performed with the catheter.There were no patient symptoms initially.The peripheral embolization was diagnosed by cine image.After the peripheral embolization, pressure decrease and st elevation occurred, and the patient experienced chest pain.A stenosis-penetration catheter was used for suction and nicorandil and nitroprusside were administered for treating the embolization.After that, stenting was performed using intravascular ultrasound as a guide, and the procedure was completed.The patient is in stable condition postoperatively.
 
Manufacturer Narrative
One dragonfly opstar imaging catheter was received for evaluation.Functional testing was not possible due to the presence of dried contrast within the catheter sheath; however, dimensional inspection revealed the purge hole diameter met the specifications.There were no anomalies, ruptures, or damages noted to the returned catheter.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the condition of the returned device and the information received, the cause of the reported leak and embolism remains unknown.
 
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Brand Name
DRAGONFLY OPSTAR¿
Type of Device
DRAGONFLY OPSTAR IMAGING CATHETER
MDR Report Key11313456
MDR Text Key231351100
Report Number3009600098-2021-00007
Device Sequence Number1
Product Code DQO
Combination Product (y/n)N
PMA/PMN Number
K192019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 08/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date09/17/2021
Device Model Number1014652
Device Lot Number7657565
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/11/2021
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/25/2021
Initial Date FDA Received02/11/2021
Supplement Dates Manufacturer Received03/01/2021
08/04/2021
Supplement Dates FDA Received03/24/2021
08/04/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/17/2020
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;
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