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

Catalog Number	C408645
Medical Device Problem Codes	Break (1069); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual analysis was performed on the returned device.The reported connection issue was unable to be confirmed due to the condition of the returned unit.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 indication of a lot specific product quality issue.The investigation was unable to determine a cause for the reported connection issue.It may be possible that damage to the optical fiber occurred during use causing the reported connection issue and error message; however, this could not be confirmed.The observed separation of the window tube was not reported and likely occurred during post-use handling/packing for return.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 that the procedure was performed in the 80% stenosed lesion in the left anterior descending artery.The dragonfly catheter could not connect to the system.Error message "the device cannot be connected.Replace the device" was noted.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 returned device analysis identified that the window tub material was separated 33cm proximal to the distal tip but remained intact to the torque wire.Follow-up with the account confirmed that this damage was not observed during the procedure.No additional information was provided.

• 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: 18445357
• Report Number: 2024168-2024-00162
• Device Sequence Number: 17832910
• 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): 01/04/2024

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: 05/22/2025
• Device Catalogue Number: C408645
• Device Lot Number: 9048355
• 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: 12/13/2023
• Initial Report FDA Received Date: 01/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ILLUMIEN OPTIS MOBILE
• Patient Sex: Unknown