Model Number 1014651 |
Device Problem
Component Misassembled (4004)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/12/2022 |
Event Type
malfunction
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Event Description
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Hold for mj 06/09
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.Sterile/unused dragonfly opstar catheters were returned.Two of the returned catheters were found to have a proximal marker band that moved distally.No patient involvement.
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Manufacturer Narrative
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The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.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 (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.The two additional dragonfly opstar devices referenced are filed under separate medwatch report numbers.
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Manufacturer Narrative
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Visual and functional analysis was performed on the returned device.The reported component misassembled was confirmed.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.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.D9: date returned to mfg.
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Event Description
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N/a.
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Search Alerts/Recalls
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