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

Model Number	C408646
Medical Device Problem Codes	No Display/Image (1183); Poor Quality Image (1408); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat the interventricular coronary artery with no tortuosity or calcification.During use of the dragonfly optis imaging catheter, after entering the anatomy when trying to connect to the ilumin optis system, an artifact image occurred and it was not possible to display an image without an error message that said 'probe not connected'.An attempt was made to reset by disconnecting and reconnecting the catheter and another error message was displayed.A new catheter was used to complete the procedure.There were no adverse patient effects and there was no clinically significant delay in the procedure.Returned device analysis identified that there was a tear on the window tube and the window tube was separated from the black sheath but held together by the torque wire.The account was not aware of the damage.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection and additional testing methods were performed on the returned device.The reported poor imaging and imaging loss were 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 poor imaging and imaging loss appears to be related to operational context.The optical fiber of the catheter was broken, which resulted in the reported poor imaging and imaging loss.The guidewire exit notch of the catheter was observed to be stretched and torn, which is consistent with use (inserted and removed from guidewire) but was determined to be unrelated to the reported poor imaging or imaging loss or the optical fiber break.In this case, it is likely that the use techniques employed caused 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: 22023059
• Report Number: 2024168-2025-05085
• Device Sequence Number: 9483574
• Product Code: DQO
• UDI-Device Identifier: 00183739000654
• UDI-Public: (01)00183739000654(17)250620(10)9096504
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/14/2025

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: 06/20/2025
• Device Model Number: C408646
• Device Catalogue Number: C408646
• Device Lot Number: 9096504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2025
• Initial Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/21/2023
• 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