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

Catalog Number	C408646
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Calibration Problem (2890)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the two dragonfly optis imaging catheters (9059464 and 8204330) were to be used in the left anterior descending (lad) lesion.However, the imaging catheters displayed an error "connection failure (395).The imaging catheter could not be connected" message displayed prior to calibration; therefore, the imaging catheters were removed and the procedure completed without using oct.It was noted that the second imaging catheter (8204330) was used after the expiration date.There were no adverse patient effects 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.H6: 2017 device code clarifier- use after expiration.
Additional Manufacturer Narrative
Visual analysis and additional testing were performed on the returned device.The reported calibration issue was not able to be confirmed due to the returned condition of the device (dried contrast within sheath) which prevented functional testing.The investigation was not able to determine the cause for the reported calibration issue.The optical fiber of the returned catheter was verified to be intact.Further, there were two successful pullbacks recorded on the returned device--suggesting two successful calibrations took place prior to the pullback activation.There was a kink observed to the catheter; however, this was determined to be unrelated to the reported event.It was determined that the returned dragonfly optis was used after expiration.The event date was (b)(6) 2023 and it was determined that the device expiration date was (b)(6) 2023.Therefore, the device was used approximately 3 weeks after the labelled product expiration date.The expiration date of the product is important for the sterility, efficacy, and performance of the device.The dragonfly optis instruction for use (ifu) lists a ¿use by¿ icon which indicates that the device is to be used prior to the expiration date on the product label.It could not be determined if using the device after the expiration date contributed to the difficulties and the returned device analysis found no issues with the 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: 18798462
• Report Number: 2024168-2024-02486
• Device Sequence Number: 7189425
• Product Code: DQO
• UDI-Device Identifier: 00183739000654
• UDI-Public: 00183739000654
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Followup
• Report Date (Section B): 03/20/2024

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: 11/07/2023
• Device Catalogue Number: C408646
• Device Lot Number: 8204330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/08/2024
• Supplement Date Received by Manufacturer: 03/18/2024
• Initial Report FDA Received Date: 02/28/2024
• Supplement Report FDA Received Date: 03/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2021
• 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