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

Catalog Number 1014651

Device Problems Difficult to Insert (1316); Difficult to Remove (1528)

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

Event Date 11/09/2023

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.Attachment: medwatch report #mw5148195.

Event Description

It was reported during preparation with the dragonfly opstar imaging catheter, the imaging catheter got stuck on the interventional wire and both the catheter and the wire had to be removed prematurely.It was also noted the imaging catheter failed to load onto the wire.A new dragonfly opstar imaging catheter was used to complete the procedure.There were no reported adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned for evaluation.Device history record (dhr) 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, the distal marker band on the catheter became damaged, or the guidewire was inadequately lubricated (wet) 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 and difficulty to insert are related to a product quality issue with respect to the design, manufacture, or labeling of the device.Correction: d9 - device available for evaluation updated from ¿yes¿ to ¿no¿ correction: h6 - health effect - impact code 2645 was removed and code 2199 was added.

• 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: 18400224
• MDR Text Key: 331414808
• Report Number: 2024168-2023-14485
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 05415067031129
• UDI-Public: (01)05415067031129(17)250802(10)9163070
• 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
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• 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: 9163070
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/03/2023
• 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