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

Model Number	C408645
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6- medical device problem code 2017: incorrect prep.Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that when the dragonfly optis imaging catheter was being prepared for the procedure, when the syringe was retracted, the air was unable to be completely evacuated from the catheter at the luer fitting.The syringe was confirmed to be secured to the catheter luer fitting.However, small bubbles were found in the catheter luer fitting, while preparing the contrast agent.Therefore, the device was not used in the patient and the procedure was completed with another dragonfly.There was no patient involvement and no clinically significant delay in the procedure.No additional information was provided.
Event or Problem Description
Subsequent to the initially filed report, follow up was received that the device was loaded onto the guide wire that entered the patient vessel.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection and functional testing were performed on the returned device.The reported air/gas in the device was not able to be confirmed.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot specific issue.Information from the field stated the plunger of the syringe was withdrawn while connected to the imaging catheter during preparation for use.The opstar instruction for use (ifu) instructs ¿the 3 ml syringe should be left attached to the sidearm to allow repeated purging throughout the imaging procedure and maintain a static pressure to prevent backflow.¿ in this case, it was determined that the failure to maintain static or positive pressure (retracting the syringe plunger) while preparing the catheter for use directly caused the reported air/gas to occur the device.Based on the reported information and the observations from the returned analysis, the investigation determined that the reported air/gas in device (bubbles in the sidearm when the syringe is retracted during purging) appears to be related to user error.The returned device was able to purge successfully and as expected, without any bubbles or air/liquid leaks noted.In this case, it was determined that the failure to maintain static or positive pressure (retracting the syringe plunger) while preparing the catheter for use directly caused the reported air/gas to occur the device.Based on the results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.H6 correction: health effect, impact code updated to 2199.

• Brand Name: DRAGONFLY¿ OPTIS¿
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): LIGHTLAB IMAGING, INC.; 4 robbins rd.; westford MA 01886
• Manufacturer (Section G): ABBOTT MEDICAL REG#3009600098; 4 robbins rd; westford MA 01886
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 23662067
• Report Number: 2024168-2025-11781
• Device Sequence Number: 10216356
• Product Code: DQO
• UDI-Device Identifier: 00183739000647
• UDI-Public: (01)00183739000647(17)260611(10)10367918
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K141769
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/11/2026
• Device Model Number: C408645
• Device Catalogue Number: C408645
• Device Lot Number: 10367918
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown