As reported by angiodynamics' distributor in poland, a hospital removed a smart port one year after implantation.The removed catheter exhibited a hole in the tubing.No patient complications were reported.No product is being returned to angiodynamics, however a photograph was provided.
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The reporting facility did not indicate the lot/batch of the affected product.Therefore no device history records review was conducted.A shipping history lot review was not performed as the item number of the device was also unknown.The (b)(6) 2017 angiodynamics complaint report was reviewed for the smartport product family and the failure mode "catheter fractured." no adverse trend was indicated.Although a device sample was not returned to angiodynamics, the hospital did provide a picture of the reported defect.Based on the photo supplied, the complaint of "hole/slice" is deemed confirmed.The hole/slice was approximately 9cm from the port.The hole in the catheter is observed to be a longitudinal slice.Without receiving product for evaluation, however, we are unable to definitively determine a root cause for this incident.Potential root cause of this failure is "pinch off syndrome" or over-pressurization of the port device.The directions for use supplied with the device instructs the physician/clinician on how to properly implant the catheter/port, and cautions against certain handling techniques to avoid "pinch-off syndrome" and over-pressurization of the port device.(b)(4).
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