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

Catalog Number C408646

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Angina (1710); Ischemia (1942)

Event Date 09/29/2023

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis.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 similar complaints.A definitive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The medical intervention appears to be related to circumstances of the procedure.The reported patient effect of angina (unstable angina) is listed in the dragonfly optis instructions for use as known potential complications which may be encountered during the procedure.In this case, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

Event Description

It was reported that the optis mobile next system (ultreon software) was successfully connected to a dragonfly imaging catheter and used in a de novo lesion in the left anterior descending (lad) artery with mild calcification and mild tortuosity.It was noted that the patient had an ischemia causing lesion.Reportedly, the physician misunderstood what was on the optical coherence tomography (oct) image display due to only having prior experience with aptiview software.When using the ultreon software, the physician thought the portion of the image on the proximal side (in the guide catheter) was actually the distal portion of the pullback.And mistook this part of the image to be blood swirl.Therefore, a second dragonfly imaging catheter was used.After two successful consecutive pullbacks, the patient experienced chest pain possibly due to induced ischemia.The ischemia was possibly exacerbated by the use of contrast during the oct procedure, but this could not be confirmed.This resulted in a clinically significant delay in the procedure.The patient was treated with fentanyl, ending the procedure.A system issue was initially suspected and a field service was requested before the physician realized this was not an issue with the system or a device, but this was a misunderstanding of the images instead.No additional information was provided.

• Brand Name: DRAGONFLY¿ OPTIS¿ IMAGING CATHETER
• Type of Device: 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: 18000063
• MDR Text Key: 326446176
• Report Number: 2024168-2023-11830
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00183739000654
• UDI-Public: 00183739000654
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K141769
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: C408646
• Device Lot Number: 9087791
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention