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

Model Number	C408645
Medical Device Problem Codes	Communication or Transmission Problem (2896); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual inspection and additional testing methods were performed on the returned device.The reported communication problem was unable 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 communication problem appears to be related to operational context.There was an optical fiber break noted to the returned catheter, which caused the reported communication failure.In this case, it is likely the use or handling techniques employed caused the optical fiber break.The observed torn guidewire exit notch is consistent with the catheter being inserted onto a guidewire and with force being used to withdraw the imaging catheter on the guidewire; however, is unrelated to the reported communication problem.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.
Event or Problem Description
It was reported that the procedure was performed in the left anterior descending (lad) artery with 80% stenosis.The dragonfly optis imaging catheter did not work normally and displayed error code 395.Another dragonfly optis was used to complete the procedure.There was no adverse patient effect and there was no clinically significant delay in the procedure.Returned device analysis identified a longitudinal tear observed in the window tube region over a length of 2.5 millimeters distally from the exit notch.No additional information was provided.

• 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: 24109181
• Report Number: 2024168-2026-00302
• Device Sequence Number: 5879256
• Product Code: DQO
• UDI-Device Identifier: 00183739000647
• UDI-Public: (01)00183739000647(17)260328(10)10251528
• 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): 01/19/2026

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: 03/28/2026
• Device Model Number: C408645
• Device Catalogue Number: C408645
• Device Lot Number: 10251528
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 01/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/28/2024
• 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