Estimated date.The udi number is "ni" as the part number was not provided.The device is not returning for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional patient effects, malfunctions, and devices referenced in the report are captured under separate medwatch report numbers.Literature attachment titled ¿post market clinical follow-up evaluation report peripheral dilatation catheter family¿.
|
The post-market clinical follow-up (pmcf) report, titled ¿post market clinical follow-up evaluation report peripheral dilatation catheter family¿ evaluated the safety and performance of the viatrac 14 plus, armada 14, armada 14xt, armada 18, armada 35, and the armada 35 ll.It was reported through a pmcf report that the armada 14 xt may be related to unsuccessful dilatation of a vessel, stent, and/or chronic total occlusion, unsuccessful delivery, inflation, and/or deflation, twisting of the balloon when used twice, embolism, dissection, perforation, limb amputation, total occlusion, abrupt closure, arrhythmia, renal failure, and thrombosis, occlusion, venous hypertension, aneurysm, pseudoaneurysm, hematoma, and hemorrhagic events.Although the above events were noted, in conclusion, the overall analyses from this study demonstrates that the use of the abbott dilatation catheters met the safety and performance criteria and perform similarly to competitive state of the art devices.
|
B3: estimated date.D4: the udi# is unknown because the part and lot numbers were not provided.D4 and h4: the device expiration and manufacturing dates could not be provided as the device lot number was not provided and the device was not returned.The device was not returned for analysis.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot and part number were not provided.A definitive cause of the reported thrombosis, embolism, perforation, dissection, occlusion, renal failure, hypertension, pseudoaneurysm, aneurysm, arrhythmia, hematoma, hemorrhage and the relationship to the product, if any cannot be determined.The reported treatment appears to be related to operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
|