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

Model Number	C408646
Medical Device Problem Codes	No Display/Image (1183); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the dragonfly optis imaging catheter did not provide an image prior to use.Therefore, the device was not used in the patient and the procedure was completed with another dragonfly.There was no patient involvement and no clinically significant delay in the procedure.Return analysis revealed the black sheath was punctured at 19 centimeters (cm) and torn at 103 and 112 cm from the proximal end of the outer shell.No additional information was provided.Hold i.P 03052025.
Additional Manufacturer Narrative
A visual inspection and additional testing methods were performed on the returned device.The reported imaging loss was not able to be confirmed.The black sheath was punctured at 19 centimeters (cm) and torn at 103 and 112 cm from the proximal end of the outer shell.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 appears to be related to circumstances of the procedure.The catheter was noted to be damaged (kinked) which resulted in the observed optical fiber break and the reported imaging loss.In this case, it is likely that the catheter was damaged due to the use or handling techniques employed.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¿ OPTIS¿
• 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: 21518630
• Report Number: 2024168-2025-02311
• Device Sequence Number: 9696184
• Product Code: DQO
• UDI-Device Identifier: 00183739000654
• UDI-Public: (01)00183739000654(17)250208(10)8867965
• Combination Product (Y/N): N
• Initial Reporter Country: QA
• PMA/510(K) Number: K141769
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/04/2025

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 Expiration Date: 02/08/2025
• Device Model Number: C408646
• Device Catalogue Number: C408646
• Device Lot Number: 8867965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/19/2025
• Initial Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/09/2023
• 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