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

Model Number 1014651

Device Problem Component Misassembled (4004)

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

Event Date 03/22/2022

Event Type  malfunction  

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.On (b)(6) 2022 abbott vascular decided to initiate a voluntary field action for specific lots of dragonfly opstartm imaging catheters.Abbott vascular submitted medwatch # 2024168-2022-03432 on april 5, 2022 with notification of the voluntary recall, (remedial action initiated).This action is being taken due to the proximal marker on devices from these lots may separate from the device.A dislodged marker may require additional intervention, including unplanned additional coronary intervention, or surgery.While no long-term adverse patient effects have been associated with this issue, marker embolization has occurred.Potential risks include cardiovascular injury and myocardial ischemia.

Event Description

It was reported that the dragonfly opstar imaging catheter was used during the procedure to treat a target lesion in the left anterior descending artery.The first pullback was performed successfully; however, when performing the second pullback, it was noted that the proximal marker moved distally on the catheter.The marker remained on the catheter when removed.There was no adverse patient effect or clinically significant delay.A second dragonfly opstar was used without issue.No additional information was provided.

Manufacturer Narrative

Visual analysis was performed on the returned devices.The reported movement of the proximal marker was confirmed.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 similar complaints reported from this lot.Based on the reported information and analysis of the returned unit, the movement of the proximal marker appears to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.

• 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: 14078831
• MDR Text Key: 289188623
• Report Number: 2024168-2022-03891
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/24/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 12/04/2023
• Device Model Number: 1014651
• Device Catalogue Number: 1014651
• Device Lot Number: 8220675
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2022
• Initial Date FDA Received: 04/11/2022
• Supplement Dates Manufacturer Received: 05/12/2022
• Supplement Dates FDA Received: 05/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2021
• 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