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

Model Number	1014651
Medical Device Problem Codes	Poor Quality Image (1408); Difficult to Remove (1528); Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that the procedure was performed in the heavily tortuous and moderately calcified de novo lesion in the left circumflex artery.The dragonfly catheter was being used; however, the image was not clear.Resistance with the anatomy was felt when removing the catheter from the patient anatomy.The procedure was successfully completed with the deployment of an unspecified drug eluting stent.There were no adverse patient effects and no clinically significant delay in the procedure.The device return analysis identified that the proximal marker band was shifted distally approximately 1 millimeter.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection, dimensional analysis, and additional testing methods were performed on the returned device.The reported poor imaging results and difficulty to remove 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 poor imaging results and difficulty to remove the catheter appear to be related to circumstances of the procedure.The catheter was received with a nitinol tube and optical fiber separation, which caused the reported poor imaging results.There were no damages nor dimensional anomalies noted to the catheter which could be directly attributed as a cause to the reported difficulty to remove.In this case, it is likely that the catheter underwent excess angulation (bending) to the strain relief which resulted in the observed nitinol tube and optical fiber separations.It is also likely that the patient¿s anatomical conditions or use techniques employed caused the observed catheter damage and reported difficulty to remove the catheter.Additional sem lab testing confirmed that the manufacturing witness marks/indications were all present and as expected¿which indicates that the marker band met manufacturing specifications.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.H6: correction medical device problem code 4004 was removed.

• Brand Name: DRAGONFLY OPSTAR¿
• 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: 23127300
• Report Number: 2024168-2025-10215
• Device Sequence Number: 15302264
• Product Code: DQO
• UDI-Device Identifier: 05415067031129
• UDI-Public: (01)05415067031129(17)260116(10)10139303
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K230411
• 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,Followup
• Report Date (Section B): 10/24/2025

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: 01/16/2026
• Device Model Number: 1014651
• Device Catalogue Number: 1014651
• Device Lot Number: 10139303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2025
• Supplement Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 09/23/2025
• Supplement Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: INTRODUCER: RADIFOCUS OF TERUMO (7 FR).
• Patient Sex: Unknown