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

Model Number	C408645
Medical Device Problem Codes	Calibration Problem (2890); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, that during the procedure the dragonfly optis imaging catheter was intended to be used in the left circumflex artery (lcx) lesion.However, the imaging catheter displayed error code 122.Therefore, the imaging catheter was removed from the patient, and the procedure was completed with another dragonfly.There were no adverse patient effects and no clinically significant delay in the procedure.Based on the results of the device analysis, the guidewire exchange minirail was torn approximately 4 millimeters (mm) distally from the exit notch.Torn material has the potential to result in foreign material in the patient and is reportable.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection and additional testing methods were performed on the returned device.The window tube was noted to be bent, and there was a tear noted on the distal edge of the guidewire exit notch.The reported calibration problem 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 calibration problem appears to be related to circumstances of the procedure.The optical fiber of the catheter was damaged, which caused the reported calibration problem.In this case, it is likely that the optical fiber damage was caused by the use or handling techniques employed.The torn guidewire exit notch is consistent with the catheter being inserted onto a guidewire and forcefully removed from the guidewire; however, the damage cannot be directly attributed as a cause for the reported event nor the optical fiber break.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¿ 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: 23950422
• Report Number: 2024168-2026-00049
• Device Sequence Number: 21522102
• Product Code: DQO
• UDI-Device Identifier: 00183739000647
• UDI-Public: (01)00183739000647(17)260415(10)10289561
• 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: Physician
• Type of Report: Initial
• 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/15/2026
• Device Model Number: C408645
• Device Catalogue Number: C408645
• Device Lot Number: 10289561
• 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: 12/16/2025
• Initial Report FDA Received Date: 01/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2024
• 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