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

Model Number	C408645
Medical Device Problem Codes	Communication or Transmission Problem (2896); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual analysis and additional testing methods were performed on the returned device.The reported communication issue was unable to be confirmed due to the returned condition of the device (dried contrast within the sheath) which prevented functional testing.Lot history record (lhr) and corrective and preventive 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.The investigation determined the cause for the reported communication issue was operational context.The optical fiber of the returned catheter was observed to be broken and was the cause for the reported and observed communication failure.In this case, the optical fiber break was likely due the use or handling techniques employed during prep or attempted connection.It should be noted that there was one successful pullback recorded and one successful pullback recorded on the returned device¿which indicates that the catheter was able to connect, calibrate, and perform a pullback for the user prior to the optical fiber break.The guidewire exit notch tear is consistent with aggressively withdrawing (excess force applied) the catheter from the engaged guidewire; however, the guidewire exit tear is unrelated to the reported communication problem.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported the dragonfly optis imaging catheter was to be used in the left anterior descending (lad) lesion.However, the imaging catheter failed to connect.An error "connection failure(395)" message displayed.Therefore, the imaging catheter was removed and another dragonfly optis imaging catheter was used to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.Based on the device analysis, the exit guidewire notch was torn.No additional information was provided.

• 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: 20305198
• Report Number: 2024168-2024-11317
• Device Sequence Number: 15384928
• Product Code: DQO
• UDI-Device Identifier: 00183739000647
• UDI-Public: (01)00183739000647(17)251113(10)10059856
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/25/2024

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: 11/13/2025
• Device Model Number: C408645
• Device Catalogue Number: C408645
• Device Lot Number: 10059856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/15/2023
• 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