As reported by angiodynamics' distributor in (b)(4), "the radiologist advised: patient with breast cancer.Port (smart port) placed at time of breast surgery (approximately 2-3 months ago).Catheter sheared off between 1st rib and clavicle - about 8cm-9cm from where the catheter attaches to the port.Distal end ended up in right ventricle/pulmonary artery.The issue was noticed under fluoro, the patient's oncologist was informed and the oncologist then arranged for an interventional radiologist to removed the distal end." the radiologist mentioned "pinch-off" as the likely cause of the catheter fracture.The implant and explant dates of the port are unknown (port still may be insitu with the retrieved portion of the catheter discarded) as is the upn and lot number of the port.
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No device history records review was conducted since there was no reported lot # and a ship history lot review was not performed since item # is unknown.The september 2018 angiodynamics complaint report was reviewed for the smartport product family and the failure mode "catheter fractures/migrated." no adverse trend was indicated.The reported complaint description of "catheter fractured " is not confirmed, nor can an exact root cause be determined, as no sample was returned for evaluation.Based on the reported information that the catheter had sheared between the 1st rib and the clavicle (approx.8-9cm from where the catheter attaches to the port) , a potential root cause for the catheter fracture is "pinch off syndrome".The hospital radiologist also mentioned "pinch-off" as a possible cause.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".(b)(4).
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