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

Model Number	1014651
Medical Device Problem Codes	Material Separation (1562); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2025
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 dragonfly opstar catheter was unable to cross due to the challenging anatomy in the heavily calcified left anterior descending coronary artery.After the catheter was removed from the patient, it was noted that the tip of the catheter had separated and remained on the back end of the guidewire, outside the patient.There were no adverse patient effects.After a non-abbott guide extension was advanced, another dragonfly opstar was used with the optis mobile next to complete the procedure.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 failure to advance was not able to be confirmed; however, the reported material separation was visually 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 failure to advance and material separation appear to be related to circumstances of the procedure.The catheter was returned with stretching, tearing, and separation of the catheter¿s sheath (distal tip and distal sheath marker band) which caused the proximal marker band to break from the bonded position and shift distal on the sheath.In this case, while the account states that no resistance was felt during imaging catheter withdrawal, the state of the returned catheter (stretched window tube and torn guidewire exit notch/distal tip) indicates that there was likely resistance during withdrawal of the imaging catheter¿which was caused by the patient¿s anatomical conditions (heavy calcification).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
Subsequent to the previously filed report, additional information was received that there was no resistance during removal of the dragonfly opstar catheter from the patient.No additional information was provided.

• 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: 23915482
• Report Number: 2024168-2025-12268
• Device Sequence Number: 9932635
• Product Code: DQO
• UDI-Device Identifier: 05415067031129
• UDI-Public: (01)05415067031129(17)261010(10)10533514
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2026

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: 10533514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2024
• 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