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

Model Number	1014651
Medical Device Problem Codes	Material Separation (1562); Component Misassembled (4004)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Embolism/Embolus (4438)
Date of Event	03/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem 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 or Problem Description
Additional information: the extended hospital stay was not related to the issue with the dragonfly.No additional information was provided.
Additional 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.
Additional 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
• Common Device Name: 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
• Report Number: 2024168-2022-03432
• Device Sequence Number: 11664906
• Product Code: DQO
• UDI-Device Identifier: 05415067031129
• UDI-Public: 05415067031129
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K192019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/09/2022
• Supplement Date Received by Manufacturer: 03/30/2022; 05/27/2022
• Initial Report FDA Received Date: 04/01/2022
• Supplement Report FDA Received Date: 04/05/2022; 06/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown