Note: product reference 4430893 is not cleared for sales in the usa, but it is similar to the product reference 5433750 cleared under #510k130576.Batch history review: the manufacturing file was reviewed.It is compliant with the specifications and no abnormality was detected during production.No other complaint has been reported on this access port batch sold since august 2017.Investigation: the device was not returned for evaluation.The xray pictures are inconclusive for the root cause of the catheter rupture.Conclusion: without device, no conclusion can drawn on the root cause of the incident.As a rare incident, no corrective action is envisaged.
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At the time of the injection by the nurse, no venous return detected.Injection performed and immediate pain and edema noticed above the access port.Explantation of the access port.During this explantation, the catheter migrated and required the patient's transfer to another hospital for ablation.
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