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

Model Number	DUO
Medical Device Problem Codes	No Display/Image (1183); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was performed in the 85% stenosed lesion in the left anterior descending artery.During pullback, no image was displayed and slight resistance was felt with the anatomy during removal.The procedure was successfully completed with a new dragonfly catheter.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual analysis and optical fiber testing were performed on the returned device.The reported imaging loss was unable to be confirmed due to the condition of the returned device as the dried contrast prevented functional testing.However, an optical fiber test was performed which revealed an optical fiber fracture at the lens region.Meanwhile, the reported difficulty to remove could not be replicated in a testing environment as it was based on operational circumstances.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 complaints reported from this lot.The investigation determined that the reported imaging loss was likely related to the circumstances of the procedure.Based on the evaluation of the returned device, the difficulty appears to be due to the noted optical fiber fracture.It is likely that during positioning within the anatomy, damage to the optical fiber occurred.Meanwhile, it may be possible the anatomical condition caused the reported difficulty to remove; 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.

• Brand Name: DRAGONFLY¿ DUO IMAGING CATHETER
• Common Device Name: INTRAVASCULAR IMAGING 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: 16087695
• Report Number: 2024168-2023-00015
• Device Sequence Number: 2044965
• Product Code: NQQ
• UDI-Device Identifier: 00183739000708
• UDI-Public: 00183739000708
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K093857
• 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,Followup
• Report Date (Section B): 02/13/2023

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: 01/21/2024
• Device Model Number: DUO
• Device Catalogue Number: C408644
• Device Lot Number: 8282019
• 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: 12/12/2022
• Supplement Date Received by Manufacturer: 02/03/2023
• Initial Report FDA Received Date: 01/03/2023
• Supplement Report FDA Received Date: 02/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2022
• 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