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

Model Number	1014651
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was performed in the left anterior descending (lad) artery with 85% stenosis.The dragonfly optis imaging was advanced without resistance but the push rod of the proximal section of the catheter broke remaining in one piece.There was no resistance during removal.Another dragonfly optis was used to complete the procedure.There was no adverse patient effect and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional Manufacturer Narrative
A visual inspection and dimensional analysis were performed on the returned device.The reported break was able to be confirmed (nitinol tube and optical fiber separation).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 break appears to be related to circumstances of the procedure.The catheter was returned with a kink to the black sheath, which caused the reported break (nitinol tube and optical fiber separation.In this case, it is likely that the kink and resulting separations were caused by excess angulation of the catheter¿s strain relief/proximal region.The damaged and proximal displaced marker band is consistent with being damaged during use, as well as the window tube stretching which was observed.The distal marker band separation is consistent with being damaged after use, as the catheter would be unable to inserted onto the guidewire, and it was confirmed the device was in one piece during use; therefore, the proximal marker band damage and displacement from manufactured location and the distal marker band separation occurred after use and are unrelated to the reported break of the nitinol tube.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
Returned device analysis identified that there was separation of the catheter distal tip, including the distal marker band.The tip was severed, with an unknown length of blue tip and the distal marker not returned.The account confirmed the device only had a break remaining in one piece and intact upon removal from the anatomy.Nothing separated in the anatomy.The account was not aware of the separation.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: 23848698
• Report Number: 2024168-2025-12170
• Device Sequence Number: 18631679
• Product Code: DQO
• UDI-Device Identifier: 05415067031129
• UDI-Public: (01)05415067031129(17)260912(10)10499742
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2026

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 Expiration Date: 09/12/2026
• Device Model Number: 1014651
• Device Catalogue Number: 1014651
• Device Lot Number: 10499742
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2025
• Supplement Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2024
• 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