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Model Number 2104 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Embolism/Embolus (4438); Swelling/ Edema (4577)
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Event Date 08/07/2023 |
Event Type
Injury
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Event Description
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A barostim system was implanted on (b)(6) 2023.The patient reported swelling in their arm beginning on (b)(6) 2023.A follow-up appointment occurred on (b)(6) 2023, and the physician scheduled an echo of the patient's arm.The echo showed a clot, and the patient was placed on blood thinners for a few weeks.In the opinion of the physician, the root cause of the clot and swelling was due to the arterial-line.As of (b)(6) 2023, the patient was feeling better.
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Manufacturer Narrative
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While analysis was unable to be performed as the device was not returned, per the opinion of the physician, the root cause of the event was due to the arterial line used during the barostim implant procedure.The device history and sterilization record for this device serial number has been reviewed.No issues or discrepancies were noted during this review that would have contributed to the reported event.The device met material, assembly, and quality control requirements.Cvrx id# (b)(4).
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Search Alerts/Recalls
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