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 recent angiodynamics complaint report was reviewed for the smartport product family and the failure mode "catheter fractured." 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 tubing was placed in the subclavian vein and fracture was located ~11 cm from port, a potential root cause for the catheter fracture is "pinch off syndrome".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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