The implicated product is a 9.
5 fr.
Dual lumen catheter with tissue ingrowth cuff in a peel-apart introducer sys.
The product rec'd for eval is a 9.
5 fr.
Dual lumen catheter measuring 23.
65 inches long.
A clean, residue-free tissue ingrowth cuff is found 14.
0 inches from the proximal end.
The strain relief proximal to the bifurcation is buckeled at its mid-section.
A lot history review reveals no mfg issues and no other complaints for this lot.
Tactual examination of the catheter reveals an annular ring with exaggeration of a small slit 17.
4 inches from the proximal end (2.
8 inches distal to the cuff).
Patency of both lumens is demonstrated by flushing and aspirating water through each with a 12cc syringe.
No leaks or aspiration of air is noted.
However, when occluding the catheter's distal tip and attempting to hydraulically pressurize each lumen to sustained pressures greater than 25 psi, a single, steady stream of water flows from the small slit located at the annular ring (17.
4 inches from the proximal end).
The leak occurs during flushing of the proximal lumen only.
No leaks are noted when flushing the distal lumen.
Under 10x magnification the slit is observed to be situated perpendicularly and is less than 0.
1 inch in length.
Each edge is well-defined and even, however, one edge has a slight half-moon shape while the opposing edge is straight.
The slits walls are realatively smooth with no striations or other descriptive landmarks but do occur at near-90 degree angles.
The proximal or straight edge has a faint impression in the outer diameter leading up to the slit.
Immediately opposite this slit, a second, smaller, non-penetrating slit is found.
This slit is also situated perpendicularly with even edges and flat, non-descript walls.
No other associated damage is noted around either slit.
The complaint of a subcutaneous leak is confirmed.
It should be recorded as user-related.
Both the penetrating and non-penetrating damage are found within the width of an annular ring suggesting the slits were caused by mechanical manipulation and may have occurred simultaneously.
The product instructions for use warns the user to exercise caution when implanting catheters to avoid mechanical damage to the material of the catheter.
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