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

Model Number	C408646
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2024
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.
Event or Problem Description
It was reported that during preparation, the dragonfly optis imaging catheter was purged and a hole was noted.There was a leak on the distal side of the imaging catheter.Therefore, the imaging catheter was not used in the patient and an unknown device was used to complete the procedure.There was no patient involvement and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection, dimensional analysis, and functional testing were performed on the returned device.The reported leak and anomalous hole were not able to be confirmed, as the device was able to purge liquid through the purge hole, without any leaks.There were no holes nor tears to the returned catheter sheath.Based on the information provided and analysis of the returned device, the cause for the reported leak and anomalous hole was unable to be determined.The returned device was able to purge as expected, and without error or leaks.It should be noted that optis and opstar model catheters are equipped with a dedicated purge hole, located proximal to the guidewire exit notch.In this case, it is likely that the user was unaware or forgot that the optis and opstar model catheters have dedicated purge exit holes; however, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
Subsequent to the initial mdr report, the following information was provided: after device analysis, it has been confirmed there was no hole on the device other than the expected purge hole.Therefore, based on the analysis, there is no issue with this device and this would not be reportable, however, since a report has already been filed, this will remain reportable.

• Brand Name: DRAGONFLY¿ OPTIS¿
• Common Device Name: DIAGNOSTIC INTRAVASCULAR CATHETER
• Manufacturer (Section D): LIGHTLAB IMAGING, INC.; 4 robbins rd.; westford MA 01886 4628
• 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: 19323970
• Report Number: 2024168-2024-05914
• Device Sequence Number: 2608000
• Product Code: DQO
• UDI-Device Identifier: 00183739000654
• UDI-Public: (01)00183739000654(17)250620(10)9096505
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 06/28/2024

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: 06/20/2025
• Device Model Number: C408646
• Device Catalogue Number: C408646
• Device Lot Number: 9096505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2024
• Supplement Date Received by Manufacturer: 06/18/2024
• Initial Report FDA Received Date: 05/15/2024
• Supplement Report FDA Received Date: 06/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2023
• 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