MAUDE Adverse Event Report: ABBOTT VASCULAR DRAGONFLY¿ OPTIS¿ IMAGING CATHETER; DIAGNOSTIC INTRAVASCULAR CATHETER

Catalog 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	11/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the dragonfly optis imaging catheter was to be used during the procedure; however, while flushing the catheter, contrast flowed from a hole in the catheter approximately 1.5cm from the tip.Therefore, the device was not used in the patient.The procedure was completed using another dragonfly catheter.There was no patient involvement and 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.
Event or Problem Description
Subsequent to the initially filed report, additional information was received.Return device analysis noted a steady stream of liquid was observed exiting the purge port, and no other locations.There was no fluid observed leaking anywhere on the device with the purge port plugged, suggesting that the reported leak from the tip was actually the purge port purging proximal to the distal tip.No additional information was provided.
Additional Manufacturer Narrative
Visual analysis and functional testing were performed on the returned device.The reported leak and ¿a hole at the tip of the device¿ were unable to be confirmed, as the returned device was able to be purged as expected with purged liquid exiting the designated purge hole.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history revealed no other similar complaints reported from this lot.The investigation determined that the cause for reported leak and ¿a hole at the tip of the device¿ were unable to be confirmed.The catheter side arm luer was connected to a syringe filled with liquid, and a liquid purge test was performed to check for a leak, as reported.A steady stream of liquid was observed exiting the purge port, and no other locations.There was no damage/hole noted to the catheter distal tip, and liquid exited proximally from the distal tip and through the dedicated purge hole.It should be noted that optis and opstar model catheters have a dedicated purge hole located proximal to the guidewire exchange minirail, on the distal portion of the sheath.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: DRAGONFLY¿ OPTIS¿ IMAGING CATHETER
• Common Device Name: DIAGNOSTIC INTRAVASCULAR CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 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: 18445482
• Report Number: 2024168-2024-00168
• Device Sequence Number: 20539650
• Product Code: DQO
• UDI-Device Identifier: 00183739000654
• UDI-Public: 00183739000654
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 03/05/2024

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 Catalogue Number: C408646
• Device Lot Number: 9096504
• 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: 12/14/2023
• Supplement Date Received by Manufacturer: 02/12/2024
• Initial Report FDA Received Date: 01/04/2024
• Supplement Report FDA Received Date: 03/05/2024
• 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