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

Model Number 1014651

Device Problems Premature Activation (1484); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/27/2022

Event Type  malfunction  

Event Description

It was reported this was a procedure to treat a left anterior descending st-elevated myocardial infarction (stemi).A dragonfly opstar catheter was inserted and advanced; however, prior to injecting contrast, the automatic pullback was triggered prematurely.The catheter was attempted to be removed but was caught on the guidewire.Therefore, both devices were removed together.A new dragonfly opstar catheter was inserted.Again, a premature pullback occurred.This time the catheter was able to be removed without issues.There were no adverse patient effects and no clinically significant delay during the procedure.The physician admitted he was advancing the dragonfly's in live mode.No additional information was provided.

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.(b)(4).

Manufacturer Narrative

Visual and dimensional analysis was performed on the returned device.The reported difficulty removing was unable to be confirmed due to the device condition.Damage to the dragonfly catheter was confirmed which is consistent with the occurrence of withdrawal difficulty.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 identified no other complaints reported from this lot.In this event, it was reported that catheter was advanced or positioned while in ¿live-view¿ mode.The instruction for use (ifu) for opstar imaging catheter caution the user to ¿ensure that the dragonfly imaging catheter is not rotating while the sterile operator is loading, inserting, or positioning the catheter¿.In this case, the catheter being in ¿live-view¿ denotes that the catheter was rotating, and the user is already aware of the error made.The investigation determined that the difficulties were likely related to circumstances of the procedure.The observed guidewire exit port damage is consistent with, and likely from, force applied by the physician/user during attempted removal of the catheter, or from the separation of the catheter from the guidewire after both were removed from the patient¿s anatomy.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: DRAGONFLY OPSTAR¿ IMAGING CATHETER
• Type of Device: DIAGNOSTIC 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: 13908414
• MDR Text Key: 288036764
• Report Number: 2024168-2022-03127
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 05415067031129
• UDI-Public: 05415067031129
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/24/2023
• Device Model Number: 1014651
• Device Catalogue Number: 1014651
• Device Lot Number: 8147186
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2021
• 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
• Treatment: GUIDE WIRE: ASAHI PROWATER.