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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIGHTLAB IMAGING, INC. DRAGONFLY CATHETER, INTRAVASCULAR, DIAGNOSTIC

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LIGHTLAB IMAGING, INC. DRAGONFLY CATHETER, INTRAVASCULAR, DIAGNOSTIC Back to Search Results
Model Number C408646
Device Problem Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/21/2022
Event Type  malfunction  
Event Description
Dragonfly catheter inserted into body. Device didn't work. Removed and new dragonfly catheter used. No harm to patient.
 
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Brand NameDRAGONFLY
Type of DeviceCATHETER, INTRAVASCULAR, DIAGNOSTIC
Manufacturer (Section D)
LIGHTLAB IMAGING, INC.
4 robbins rd
westford MA 01886
MDR Report Key15026410
MDR Text Key295968575
Report Number15026410
Device Sequence Number1
Product Code DQO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 07/08/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/15/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberC408646
Device Catalogue NumberC408646
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/08/2022
Event Location Hospital
Date Report to Manufacturer07/15/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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