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

Catalog Number	C408645
Medical Device Problem Codes	No Display/Image (1183); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2021
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 the dragonfly optis catheter did not display an image during the procedure.Therefore, the catheter was removed and a replacement device was used to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.The device return analysis revealed that the window tube material was stretched distal to the lens marker band for approximately 8 inches.The tip along with the sheath marker band was separated.No additional information was provided.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Visual analysis and additional testing were performed on the returned device.The imaging issue was unable to be confirmed due to the condition of the returned device (dried contrast within the sheath and catheter sheath damage) which prevented functional testing; however, the separation of the distal tip was able to be confirmed upon visual inspection.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.A query of the complaint handling database for the reported lot was performed and revealed there is no indication of a lot level quality product issue.The investigation was unable to determine a root cause for the reported imaging loss and tip separation.It is possible the reported loss of imaging was caused by either the patient anatomical condition(s) or a system issue; however, this could not be confirmed.The optical fiber of the catheter was confirmed to have remained intact.There was stretching in the window tube resulting in a separation of the distal tip of the catheter, which resulted in the distal edge of the guidewire exit notch being the most distal part of the returned device.The distal portion of the catheter separation was not returned and was most likely due to the use technique/angle of removal when the catheter was being removed from the guidewire once outside of the guide catheter.The separation would have likely occurred outside the patient or during post procedure handling/removal and was unrelated to the reported imaging issue.It should be noted that there were two successful pullbacks recorded on the returned device.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: 17898275
• Report Number: 2024168-2023-11077
• Device Sequence Number: 3366981
• Product Code: DQO
• UDI-Device Identifier: 00183739000647
• UDI-Public: 00183739000647
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 12/20/2023

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: 12/14/2022
• Device Catalogue Number: C408645
• Device Lot Number: 7761886
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/15/2023
• Supplement Date Received by Manufacturer: 12/06/2023
• Initial Report FDA Received Date: 10/09/2023
• Supplement Report FDA Received Date: 12/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2020
• 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