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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR DRAGONFLY OPSTAR¿ IMAGING CATHETER; DIAGNOSTIC IMAGING CATHETER Back to Search Results
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.
 
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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 Key13972130
MDR Text Key288356679
Report Number2024168-2022-03432
Device Sequence Number1
Product Code DQO
UDI-Device Identifier05415067031129
UDI-Public05415067031129
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K192019
Number of Events Reported1
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 Received04/01/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/02/2023
Device Model Number1014651
Device Catalogue Number1014651
Device Lot Number8220672
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/21/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/27/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/02/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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