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	11/11/2024
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 an error code (395).Therefore, the imaging catheter was removed from the patient, and the procedure was completed with another dragonfly optis.There were no adverse patient effects and no clinically significant delay in the procedure.Returned device analysis identified a tear was observed in the exit notch.The account was not aware of the tear during the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection and additional testing methods were performed on the returned device.The reported communication 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 communication problem appears to be related to operational context.The optical fiber break is consistent with the reported communication issue.In this case, it is likely that the optical fiber break occurred due to the use or handling techniques employed.It should be noted that there was one connection (load) and one pullback recorded on the returned device¿which indicates that the catheter was able to successfully connect, calibrate, and perform one pullback for the user prior to the optical fiber break and being returned.The stretched and torn guidewire exit notch is consistent with the catheter being inserted onto a guidewire but is also 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.

• 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: 21061045
• Report Number: 2024168-2025-00061
• Device Sequence Number: 18181030
• Product Code: DQO
• UDI-Device Identifier: 00183739000647
• UDI-Public: (01)00183739000647(17)260110(10)10141283
• 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): 01/02/2025

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: 01/10/2026
• Device Model Number: C408645
• Device Catalogue Number: C408645
• Device Lot Number: 10141283
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/17/2024
• Initial Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2024
• 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