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

Model Number	C408645
Medical Device Problem Codes	No Display/Image (1183); Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual inspection and additional testing methods were performed on the returned device.The material separation was able to be confirmed; however, the reported difficulty to remove the catheter and imaging loss were 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 imaging loss, difficulty to remove the catheter, and material separation appear to be related to circumstances of the procedure.The catheter was returned with multiple bends, kinks, stretches, fraying, separation, and an optical fiber break which resulted in the reported material separation and imaging loss.In this case, it is likely that the difficulty to remove the catheter from the y-valve was caused by the valve not being fully opened, which resulted in the difficulty to remove and reported/observed catheter damage.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 the dragonfly optis imaging catheter was to be used in the right coronary artery (rca).However, the imaging catheter failed to image.Therefore, the imaging catheter was removed and another dragonfly optis imaging catheter was used to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.Returned device analysis identified the black sheath was separated from the window tube that includes the distal marker band and catheter distal tip.The account confirmed the separation occurred during removal from the y valve when the contrast agent in the catheter got stuck to the valve.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: 22366275
• Report Number: 2024168-2025-06740
• Device Sequence Number: 9582263
• Product Code: DQO
• UDI-Device Identifier: 00183739000647
• UDI-Public: (01)00183739000647(17)260507(10)10314190
• 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): 06/30/2025

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: 05/07/2026
• Device Model Number: C408645
• Device Catalogue Number: C408645
• Device Lot Number: 10314190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2024
• 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