(b)(4).
On march 14, 2017, abbott vascular decided to initiate a voluntary field action for some sizes and lots of the nc trek family of dilatation catheters for difficulty to remove sheath which may lead to inflation or deflation issues, [medwatch # 2024168-2017-02310].
The device was received.
Investigation is not yet complete.
A follow up report will be submitted with all relevant information.
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It was reported that 3.
25 x 20 mm nc trek dilatation catheter was advanced, over an unspecified guide wire, into the patient anatomy to perform post-dilatation of an unspecified stent.
The guide wire was not wiped prior to advancement of the nc trek, and there was some resistance between the two devices during advancement; however, the nc trek was able to advance to the target lesion.
An attempt was made to reposition the balloon within the stent; however, it was noted that the device shaft broke in the mid-section of the device, while in the guide catheter.
A 3.
0 non-abbott dilatation catheter was advanced into the guide catheter and inflated in order to trap the separated device.
All devices were then removed as a single unit, including all segments of the separated device.
The procedure continued with use of a non-abbott dilatation catheter.
There was no adverse patient effect.
A delay in procedure was reported, due to the device separation; however, it was not clinically significant.
No additional information was provided.
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(b)(4).
Evaluation summary: visual and functional inspections were performed on the returned device.
The shaft separation was confirmed.
The difficulty positioning the guide wire was not confirmed.
The investigation determined the reported difficulties appear to be related to circumstances of the procedure.
A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.
Additionally, a review of the complaint history identified no other similar incidents from this lot.
There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
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