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

Catalog Number 1014651

Device Problem Difficult to Remove (1528)

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

Event Date 11/09/2023

Event Type  malfunction  

Event Description

It was reported the dragonfly opstar imaging catheter was to be used in unspecified lesion.However, the imaging catheter got stuck on the interventional wire near the end of the case and both the catheter and the wire had to be removed prematurely.Therefore, the imaging catheter was removed due to inability to remove the catheter from the interventional wire and it is unknown how the procedure completed.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.Attachment medwatch report #mw5148197.

Manufacturer Narrative

The device was not returned for evaluation.The lot history record and exception reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot specific issue.In this case it is possible that the guidewire being used became damaged or the patient anatomical conditions affected the ability to remove the catheter; however, this could not be confirmed.Based on the reported information and results of the complaint investigation there is no indication that the reported difficulty to remove is related to a product quality issue with respect to the design, manufacture, or labeling of the device.D9 - device available for evaluation updated to ¿no¿.

• 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: 18378952
• MDR Text Key: 331370657
• Report Number: 2024168-2023-14346
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 05415067031129
• UDI-Public: (01)05415067031129(17)250813(10)9189420
• 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: User Facility,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1014651
• Device Lot Number: 9189420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/14/2023
• 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