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Model Number 38270 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/12/2020 |
Event Type
Injury
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Event Description
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It was reported that tip detachment occurred.A 5fr imager ii angiographic catheter was selected for a splenic artery embolization procedure.A femoral approach was used to access the mildly calcified eccentrically shaped lesion.The anatomy was not tortuous.During the procedure, the tip of the catheter detached inside the patient.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
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Event Description
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It was reported that tip detachment occurred.A 5fr imager ii angiographic catheter was selected for a splenic artery embolization procedure.A femoral approach was used to access the mildly calcified eccentrically shaped lesion.The anatomy was not tortuous.During the procedure, the tip of the catheter detached inside the patient.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.It was further reported that the imager was being introduced through a 6f sheath at the time of the tip detachment.Approximately 3-5cm of the tip detached.The tip was retrieved with a snare.There were no patient complications.
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Manufacturer Narrative
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Updated: adverse event/product problem, outcomes attributed to adv event, describe event or problem, type of reportable event.
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Search Alerts/Recalls
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