Cordis vista brite tip

A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint. One non sterile cordis brite tip 6f. The luer hub was found to be cracked and separated in two pieces; one part remained attached to the y connector also received in the same plastic bag.

The hub was cracked at the partition line. The distal brite tip of the catheter was retrieved inside lumen. The received 6f. No other visual anomaly was found on the received unit. The catheter id was measured at different sections and results were found within specification. The hub of the returned unit was submitted for sem scanning electron microscope analysis and the results revealed that the crack in the hub had spread entirely through the wall thickness of the hub.

The external surface of the hub presented no anomalies. Some of the fracture surfaces for the hub exhibit areas that are brittle in appearance. No visual evidence of any chemical degradation or cutting in the material was noted.

Functional analysis to introduce any device throughout catheter lumen could not be performed due to retrieved inside lumen condition of brite tip of the received unit. Tga thermogravimetrical analysis analysis performed revealed differences in thermal properties of the complaint sample potentially related to additives or changes in the formulation.

In addition it was demonstrated that fracture was induced by the brittleness of the material itself, and not by apply an overload on the hub. Dhr review could not be performed since lot number was not provided by the customer. Resistance friction may be caused by inadequate flushing of the guide catheter or crystallization of contrast media within the device or on the balloon catheter. The catheter id measurements were found within specification, so this event is not considered manufacturing related of the product.

This compliant will be included in the scope of a capa. It is not possible to determine the exact cause of the difficulty experienced by the customer; however, based on information available for review, multiple inflations and the angulation of the renal artery may have contributed to the withdrawal difficulty reported. Neither the dhr nor the event description suggests that the withdrawal difficulty could be related to the manufacturing process of the device; therefore, no corrective action will be taken.

As reported by an affiliate, friction was felt with an aviator plus while being removed from the patient. The aviator plus became got stuck near the distal end portion of a 6f vista brite tip lot unknown guide catheter.

The aviator plus was removed intact with the gc. Therefore, a different bc was used with a different non-cordis guiding catheter. The procedure was finished successfully. A contralateral approach was used. Initially, approach was made from the right femoral artery with the 6f guidecatheter and it was engaged to the ostium of the target lesion. The lesion was crossed with a crice guidewire and pre-dilation was conducted with a bc aviatorplus. Then, the aviator plus was delivered for additional dilation and it was inflated at the lesion at 8atm.

It was not indicated if there was difficulty tracking through the vasculature. It is unknown if the vasculature preceding the target lesion was tortuous. The target lesion was the left renal artery. It is unknown if the lesion was a de novo, but was not calcified. Open the catalog to page 7. Open the catalog to page 8. Open the catalog to page 9.

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