Event was reported to angiodynamics via an email from the (b)(4) in the (b)(6) (report # (b)(4)): details of incident / nature of device defect: port-a-cath found to have come apart whilst in-situ.Linogram used to examine on the presence of symptoms (unable to aspirate and swelling noted), showing that the hub section had come apart from the tubing.The blue cuff which connects the hub to the tubing still connected to the hub, so appears that the line has come away from inside this cuff.Details of injury (to patient, carer or healthcare professional): initial symptoms (unable to aspirate port and swelling).The line had migrated to lie in the svc and right atrium, creating a high risk.Unplanned surgery required under anaesthetic to remove the line from the heart.Patient has severe anxiety issues, which were aggravated by this incident.Action taken (includes any action by patient, carer or healthcare professional, or by the manufacturer or supplier): consultant informed of findings.Linogram halted, original planned procedure cancelled.Port-a-cath and line removed under anaesthetic by the interventional radiology team.Note from team regarding the removal: "after the intravascular tubing had been retrieved from the heart and svc by the adult intervention radiology team the chest was x-ray screened and confirmed to contain no residual tubing or wire with the portacath remaining on the right side of the chest wall externally.The previous right sided port scar was excised and the port removed by dissecting it out of its fibrin sheath and removing any visible traces of the three prolene sutures which were still fixing it to the chest wall.The blue silastic appearing cuff which normally fits over the junction of the white intravascular tubing to the metallic hub was still in situ and was removed with the hub.The wound was closed with 3/0 and 5/0 vicryl and steristrips.A total of 10ml 0.25% bupivacaine was infiltrated around the port-removal site." angiodynamics has contacted the user hospital, and the device from the reported incident will be returned for evaluation.
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A review of the device history records was performed for the indicated packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly and performance specifications.The (b)(6) 2018 angiodynamics complaint report was reviewed for the smartport product family and the failure mode "catheter fractured/migrated." no adverse trend was identified.Returned for evaluation was one smartport with the blue strain relief attached to the port outlet.The catheter tubing was detached / fractured approximately 1 cm away from the proximal end of the tubing where the catheter is attached to the port outlet tube.Dimensional check: the catheter was measured (id and od) and found to be within specification.The port outlet tube was measured (od) and found to be within specification.The lock was measured (id) and found to be within specification.Although a definitive root cause for the catheter tubing fracture could not be determined, it does not appear to be a manufacturing-related issue.It was found the that the blue strain relief was assembled backwards on the port.The catheter and blue strain relief mechanism are provided as separate components with the port assembly kit.The end user attaches the catheter tubing and blue strain relief mechanism to the port during the implantation procedure.Having the blue strain relief assembled backwards onto the port outlet tube/catheter connection and/or flexing of the catheter tubing at this location are potential contributing factors to the tubing fracture.The directions for use (dfu) packaged with the port contains the following instructions regarding the blue strain relief mechanism: " slide the blue strain relief mechanism over the end of the catheter.The tapered end of the blue strain relief mechanism should point away from the proximal end of the catheter.For optimal results, the proximal end of the catheter should be dry.Slide the trimmed end of the catheter tip onto the stem until the catheter is flush with the stem flanges.Slide the strain relief mechanism over the catheter and onto the stem until it contacts the port body." ((b)(4)).
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