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

Model Number	1014651
Medical Device Problem Codes	No Display/Image (1183); Deformation Due to Compressive Stress (2889); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2025
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 the dragonfly opstar imaging catheter was to be used in the left anterior descending (lad) lesion.However, there was lens damage, and a kink was noticed.An error message "manually unload the catheter" was displayed.Therefore, the imaging catheter was removed and another dragonfly opstar imaging catheter was used to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.Returned device analysis found there was a longitudinal tear in the catheter distal tip from the exit notch to the distal tip.The distal sheath marker was not present.The distal tip was frayed and torn.The tip of the catheter, including the distal sheath marker, was separated from the main body of the catheter.The separated components were not returned.The account confirmed the tear was noted during the procedure as the guide wire got snatched during the post pull back and while separating the wire, the distal part got torn.
Additional Manufacturer Narrative
A visual inspection, dimensional analysis, and additional testing methods were performed on the returned device.The reported tear was able to be confirmed; however, the reported kink 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, kink, and torn material appear to be related to circumstances of the procedure.The catheter was returned with the distal tip stretched to the point of a tear resulting in separation of the distal sheath marker band and distal portion of the guidewire exchange rail¿which are consistent with the reported material tear.The catheter was also returned with an optical fiber break, which caused the reported imaging loss but is unrelated to the observed catheter sheath damage.There were no kinks, bends, nor damage noted to the returned device which could be directly attributed to the reported kinked sheath.In this case, it is likely that the optical fiber break and catheter sheath damage which resulted in separation were caused by the use/handling techniques employed or the condition of the employed guidewire.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 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: 24039825
• Report Number: 2024168-2026-00217
• Device Sequence Number: 10546852
• Product Code: DQO
• UDI-Device Identifier: 05415067031129
• UDI-Public: (01)05415067031129(17)261028(10)10574320
• 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): 02/04/2026

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 Model Number: 1014651
• Device Catalogue Number: 1014651
• Device Lot Number: 10574320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2024
• 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