A subcutaneous leak was not found during the evaluation of the sample returned.
Hydraulic testing of the catheter showed it to be occluded with a crystallized material.
The product implicated is a 9.
5 fr dual lumen cv catheter.
Returned is one assembled catheter that measures 21.
6" in length.
A blue monofilament suture is tied to the catheter just proximal to the cuff.
Tissue and blood residue is found on the cuff.
A blood residue is seen imbedded in the cuff.
A clear crystallized material is found throughout the catheter tubing.
A chr review of lot#36hj0110 shows no other product complaints of similar nature.
According to the incident questionnaire, the catheter was placed in 2001.
The next day, as chemotherapy was started, pt experienced severe neck pain with swelling.
Was returned to interventional radiology where the catheter was removed and found to have crack above level of the vein.
During decontamination, the catheter failed to infuse from both the distal and proximal lumens.
Upon further evaluation, patency could not be established due to the catheter being occluded.
A comparison tactile exam was done between the sample received and a catheter from the bas lab.
The catheter returned by the complainant shows the tubing proximal to the vitacuff not as pliant as the catheter from the bas lab.
The catheter was placed under 10x magnification.
A comparison of the two catheters reveals a dramatic difference in tubing clarity.
A clear crystallized material is found in both the proximal and distal lumens (see photo).
The crystallized material found inside the catheter tubing is highly reflective in magnified light.
This material is found along the length of the catheter with a higher concentration found between the bifurcation and vitacuff.
Since a confirmation of a leak site could be confirmed hydraulically, a microscopic exam was done to the entire length of the catheter.
No splits or gaping holes in the catheter were found however, a palpable impression in the tubing is found 0.
9" proximal to the distal tip (see photo).
A vein pick was used to probe this impression in the tubing.
There is no breaching of the outer tubing wall.
A subcutaneous leak was not found during the evaluation of the sample returned.
Hydraulic testing of the catheter showed it to be occluded with a crystallized material.
A visual and microscopic exam of the catheter tubing showed no sources of a leaks site.
However, an impression in the tubing was found just proximal to the distal tip.
This may have been done by the user during removal of the catheter or during placement.
A tactile exam showed the catheter not as pliant in the areas of the concentrated crystallized material.
This complaint is inconclusive due to the condition of the sample returned.
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