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

Model Number	1014651
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2025
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.The additional device referenced in b5 and d10 is captured under a separate medwatch number.
Event or Problem Description
It was reported that the procedure was to treat the first obtuse marginal (om1) and left anterior descending (lad) coronary arteries with 85-95% stenosis and calcification.Left radial access was gained and a 6fr 4.5 guide catheter was advanced and seated coaxially in the ostium of the left main (lm).The blance middleweight (bmw) guide wire was inserted and advanced without difficulty to the distal om1.A 2.5x15 mm trek balloon was used for pre-dilatation and the dragonfly opstar imaging catheter was advanced.One run was successfully imaged.Upon removal of the dragonfly, there was a lot of resistance.The guide wire and dragonfly had to be removed together as a unit.Once outside the anatomy, the wire was found to be frayed and coiled like a ribbon.The anatomy was imaged again with fluoro and a piece of wire was seen in the vessel.A snare was unsuccessful.A 2.75x28 mm xience skypoint stent delivery system (sds) was attempted to be advanced to embed the wire piece into the vessel wall; however, it could not cross.A 2.5 mm trek balloon was ultimately used to tack the wire piece to the vessel wall and a non-abbott stent was implanted.A final oct run was performed with a new dragonfly opstar.Everything looked good at this point.The physician then decided to switch to the lad and finish the procedure.This was successful using two more runs of oct to image the lad.The 2.75 x 28 xience skypoint sds was used on this vessel and crossed with ease.The patient remained stable throughout the procedure.The patient was discharged the next day with no issues.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.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 difficulty to remove appears to be related to circumstances of the procedure.The catheter was returned with a stretched and torn guidewire exit notch, which is consistent with the imaging catheter being inserted onto a guidewire and with force being used to withdraw the imaging catheter on the guidewire.In this case, it is likely that the condition of the guidewire (¿frayed and coiled like a ribbon¿) caused the reported difficulty to remove the imaging catheter and the stretched/torn guidewire exit notch.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: 23844697
• Report Number: 2024168-2025-12165
• Device Sequence Number: 9958553
• Product Code: DQO
• UDI-Device Identifier: 05415067031129
• UDI-Public: (01)05415067031129(17)270528(10)10862410
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 02/04/2026

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: 10862410
• 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: 12/04/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BMW GUIDE WIRE
• Patient Sex: Unknown