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

Model Number 1014651

Device Problems Material Separation (1562); Component Misassembled (4004)

Patient Problems Foreign Body In Patient (2687); Embolism/Embolus (4438)

Event Date 03/08/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that on (b)(6) 2022 a dragonfly opstar oct catheter was used in the left anterior descending (lad) coronary artery for pre-treatment imaging.A stent was implanted in the lad.A new dragonfly opstar oct catheter was used for post treatment imaging in the lad without incident.The physician noticed what appeared to be an extra marker on the dragonfly opstar.During removal, the suspected extra marker identified on fluoroscopy had become a loose marker and caught on the guide catheter.The loose marker then detached and embolized down the left circumflex coronary artery.The left circumflex was stented, but not in the area of the foreign body.No attempt was made to remove the foreign body.The patient was stable post procedure and was discharged from the hospital on (b)(6) 2022.No additional information was provided.

Event Description

Additional information: the extended hospital stay was not related to the issue with the dragonfly.No additional information was provided.

Manufacturer Narrative

Abbott is initiating a field action for specific lots of dragonfly opstar imaging catheters.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.Na.

Manufacturer Narrative

Visual analysis was performed on the returned devices.The reported component misassembled and material separation 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.The reported patient effect of embolism is listed in the dragonfly opstar instruction for use as a known complication that may occur as a consequence of intravascular imaging and catheterization procedures.Based on the reported information and analysis of the returned unit, the dislodgement of the proximal marker on the dragonfly catheter resulting in embolism, foreign body in patient and unexpected medical intervention appears to be related to a potential product quality issue.On march 30th, 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 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.

• 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: 13972130
• MDR Text Key: 288356679
• Report Number: 2024168-2022-03432
• 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

• Is this an Adverse Event Report?: Yes
• 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: 8220672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/09/2022
• Initial Date FDA Received: 04/01/2022
• Supplement Dates Manufacturer Received: 03/30/2022; 05/27/2022
• Supplement Dates FDA Received: 04/05/2022; 06/07/2022
• 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
• Patient Outcome(s): Other