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

Catalog Number	C408645
Medical Device Problem Codes	Poor Quality Image (1408); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was performed in the 80% stenosed lesion in the left anterior descending artery.The dragonfly catheter was connected normally and a second pullback was performed.However, the device did not display a normal image.The procedure was successfully completed with a new dragonfly catheter.There were no adverse patient effects and no clinically significant delay in the procedure.The return device analysis identified that there were multiple tears noted throughout the window tube at approximately 37mm proximal to the distal end.No additional information was provided.
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) which prevented functional testing.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.Based on the information provided and analysis of the returned device, the reported poor imaging results were due to operational context.It is likely that the observed optical fiber break caused the reported imaging issue.It could be that the patient¿s anatomical condition(s) or the use technique(s) employed by the user caused the observed optical fiber damage; however, this could not be confirmed.There were multiple tears throughout the window tube of the sheath, and at the site of bends/kinks.The tears would have occurred outside the patient and during post procedure handling/removal, as the device would not have been able to function as expected if the damage was present during use.The damage was determined to be unrelated to the reported imaging issue and observed optical fiber break and was due to post-use conditions/handling.It should be noted that there were five (5) 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.Na.

• 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: 18437398
• Report Number: 2024168-2024-00072
• Device Sequence Number: 20748488
• Product Code: DQO
• UDI-Device Identifier: 00183739000647
• UDI-Public: 00183739000647
• 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): 01/03/2024

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: 05/17/2024
• Device Catalogue Number: C408645
• Device Lot Number: 8465405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2023
• Initial Report FDA Received Date: 01/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2022
• 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