It was reported that the port device was implanted in (b)(6) 2017 for adjuvant systemic antineoplastic therapy for colon cancer, with a high risk of recurrence.Chemotherapy completed in (b)(6) 2017, device kept in place since then and regularly subjected to maintenance washings during the five years of fluorouracil.In (b)(6) 2022 (last visit), removal was requested due to the malfunction and after 5 years from the installation.During the removal procedure, evidence of cvc dislocation from the body was noted, requiring removal with an angiographic procedure.
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Other, other text: additional information added to h6 and h10.This remediation mdr was generated under protocol (b)(4), as a result of warning letter (b)(4).No problems or issues were identified during this device history record review.A product sample was received for evaluation.Visual and functional testing were performed.Visual observation using the unaided eye as well as 5x to 20x microscopy found the catheter had multiple small longitudinal splitting about itself at the distal end of the attached catheter as well as the distal end of the unattached length which coincided with the maximum diameter of the outlet tube bulb.The root cause of the reported issue was found to be most likely been implanted for an extended period of time.No actions were taken.
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