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

Model Number	1014651
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Difficult to Advance (2920)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the dragonfly opstar imaging catheter was intended to be used in a moderately calcified, moderately tortuous right coronary artery (rca) lesion.The imaging catheter met resistance during advancement with the anatomy and was not tracking right.Therefore, the catheter was removed, however during removal resistance was felt with the tortuous lesion and precarious guide and guide liner engagement.Once removed it was noted that a maker was missing.Angiogram was performed and found that a marker remained free floating in the patient distal pda, intervention was not performed.The procedure was completed with another dragonfly.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional Manufacturer Narrative
A visual inspection and dimensional analysis were performed on the returned device.The reported material separation was able to be confirmed; however, the difficulty to advance and remove the imaging catheter 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.Based on the reported information and the observations from the returned analysis, the investigation determined that the reported the difficulty to advance, remove the imaging catheter, and material separation appear to be related to circumstances of the procedure.The catheter was returned stretched and torn, which resulted in separation of the distal tip including the distal marker band which resulted in a foreign body in the patient.In this case, it is likely that patient¿s anatomical conditions caused the difficulty to advance and remove the imaging catheter.The continued withdrawal attempt of the imaging catheter against resistance, instead of removing the catheter and guidewire as a unit once the imaging catheter was stuck, caused the material separation which resulted in the foreign body in the patient.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.

• Brand Name: DRAGONFLY OPSTAR¿
• 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: 23805086
• Report Number: 2024168-2025-12029
• Device Sequence Number: 9389449
• Product Code: DQO
• UDI-Device Identifier: 05415067031129
• UDI-Public: (01)05415067031129(17)270611(10)10891985
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K230411
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1014651
• Device Catalogue Number: 1014651
• Device Lot Number: 10891985
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 01/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2025
• 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
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 100 KG
• Patient Race: Black Or African American