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

Model Number	1014651
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2025
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.H6: medical device problem code 2017: failure to follow steps / instructions.
Event or Problem Description
It was reported the dragonfly opstar imaging catheter was to be used in the right coronary artery (rca).However, the imaging catheter became stuck on the non-abbott guidewire.Force was applied to remove the imaging catheter off the guidewire and the tip of the imaging catheter separated and remained on the guidewire.Both were removed in one piece.The procedure completed without using a replacement.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection and dimensional analysis were performed on the returned device.The reported difficulty to remove was not able to be confirmed, but the reported material separation was 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.Information from the field stated that continued removal force was used during the imaging catheter¿s withdrawal upon experiencing resistance during the imaging catheter¿s attempted removal.The opstar instruction for use (ifu) warns that ¿if resistance is noted during withdrawal of the dragonfly opstar imaging catheter¿ to first ¿stop manipulation and evaluate under fluoroscopy¿ and ¿if the cause of resistance cannot be determined or mitigated, carefully remove the dragonfly opstar imaging catheter and guide wire as a unit from the patient¿.In this case, it was determined that the user continuing to attempt imaging catheter removal against resistance and not removing the guidewire and imaging catheter as a unit upon resistance, caused the reported and confirmed material separation.Based on the reported information and the observations from the returned analysis, the investigation determined that the reported difficulty to remove which resulted in separation of the distal tip appears to be related to user error.The catheter was returned with torn guidewire exit notch and exchange rail which resulted in a separation, which are consistent with the reported material separation as well as effects of the reported difficulty to remove.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: 23651221
• Report Number: 2024168-2025-11763
• Device Sequence Number: 4823919
• Product Code: DQO
• UDI-Device Identifier: 05415067031129
• UDI-Public: (01)05415067031129(17)270612(10)10902330
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 12/17/2025

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 Model Number: 1014651
• Device Catalogue Number: 1014651
• Device Lot Number: 10902330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2025
• Supplement Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2025
• 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