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 03/09/2022

Event Type  malfunction  

Event Description

It was reported that the dragonfly opstar was in the patient anatomy when there appeared to be four markers on the dragonfly opstar catheter found under fluoroscopy; therefore, this was not used for the procedure.When the device was removed and inspected, there was a loose extra marker band on the outside of the shaft of the device.Another dragonfly opstar was used to complete the procedure without issue.There were no adverse patient effects.No additional information was provided.

Manufacturer Narrative

Visual, fourier transform infrared (ftir) spectroscopy, and scanning electron microscopy (sem) analysis was performed on the returned device.The reported component misassembled was confirmed.There was no fourth marker present on the device as reported; however, the proximal marker on the dragonfly catheter had moved from its original position.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.Based on the reported information and analysis of the returned unit, the movement of the proximal marker on the dragonfly catheter from its original position 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.

Event Description

N/a.

Manufacturer Narrative

On march 30th, 2022 abbott vascular decided to initiate a voluntary field action for specific lots of dragonfly opstar imaging catheters.Abbott vascular submitted medwatch # 2024168-2022-03432 on april 5, 2022 with notification of the voluntary recall in h7, (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

Subsequent to the previously filed report, sterile/unused dragonfly opstar catheters with the same lot number were returned.Two of the returned catheters were found to have a proximal marker band that moved distally.

Manufacturer Narrative

The two additional dragonfly opstar catheters referenced in b5 are filed under separate medwatch report numbers.

• 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: 13971657
• MDR Text Key: 288373790
• Report Number: 2024168-2022-03427
• 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,Followup
• Report Date: 06/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/02/2023
• Device Model Number: 1014651
• Device Catalogue Number: 1014651
• Device Lot Number: 8220673
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2021
• 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