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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL CATD DRAGONFLY OPSTAR; DRAGONFLY OPSTAR IMAGING CATHETER
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ST. JUDE MEDICAL CATD DRAGONFLY OPSTAR; DRAGONFLY OPSTAR IMAGING CATHETER Back to Search Results
Model Number 1014652
Device Problem Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/29/2020
Event Type  malfunction  
Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
 
Event Description
After completion of the procedure and after removing the device from the patient's anatomy, the physician pinched the proximal marker.The marker moved more than expected.No additional information is expected.
 
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)
ST. JUDE MEDICAL CATD
4 robbins drive
westford MA 01886
MDR Report Key10095822
MDR Text Key193076287
Report Number3009600098-2020-00014
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
Report Date 07/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/28/2021
Device Model Number1014652
Device Lot Number7404856
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received06/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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