(b)(4).
During processing of this complaint, attempts were made to obtain complete event, patient and device information.
(b)(4).
The device was received.
Investigation is not yet completed.
A follow up report will be submitted with all additional relevant information.
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It was reported that the procedure was to treat a mildly tortuous and moderately calcified right carotid artery in the carotid siphon area.
A 6.
0 x 20 mm viatrac plus peripheral dilatation catheter was used; however, a kink in the shaft was noted during unpacking.
Therefore, the device failed to cross the lesion and was replaced with a 4.
0 x 20 mm trek balloon dilatation catheter to successfully complete the procedure.
There were no adverse patient effects and no clinically significant delay in the procedure.
No additional information was provided.
Returned device analysis revealed that there was a white foreign material on the skive/bayonet of the device.
Follow-up was performed regarding the white foreign material; however, the hospital stated the foreign material was not noticed.
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