The product implicated is a catheter repair kit.
Returned for eval is a repaired catheter.
The catheter measures 11.
7" in length.
The catheter has been cut 2.
2" distal to the repair site.
The distal end of the catheter was not returned for eval.
A blood residue is found on the exterior of the catheter.
A brown residue is found inside the crevices of the occlusion clamp.
A complaint history review cannot be done due to no mfg lot number was given.
Initial complaint is the connector for inside the connection was moved after restoration by the repair kit.
The user in this complaint may be referring to the stent moved after the catheter repair was completed.
During decontamination, the catheter was found patent to infusion.
Upon further eval the distal tip was manually occluded and a 12-cc syringe filled with water was attached.
The catheter was hydraulically pressurized with a 12-cc syringe filled with water.
No leaks were observed.
The catheter was observed under 10x magnification.
The repair site shows a complete adhesive bond between the catheter and the distal end of the repair oversleeve.
The proximal end shows a void between the catheter and repair oversleeve.
Observing the proximal end of the catheter, shows it to be jagged and irregular.
The instructions for use recommends the user to cut the damaged catheter at a 90-degree angle just distal to the damaged area.
This will facilitate a proper connection bond.
Next, an incision was made to the tubing at the distal end.
The stent has migrated 1.
5" distal to the repair site.
The user does not indicate in this file the size syringe that was used to access this catheter.
The tubing was split in half to expose the repair stent.
The stent was removed from the catheter and its "od" was measured.
The stents "od" is within specifications.
A tactile exam shows no silicone adhesive adhering to the metal stent.
The repair site was split in half to have a cross sectional view of the repair site.
No silicone adhesive is found between the repair lumen and the proximal end of the catheter.
The ifu states, "use syringe to apply adhesive onto the outside of the catheter around the spliced joint, covering an area about 1 inch in overall length.
Slide the splicing sleeve down and center it over the joint.
Inject adhesive underneath each end of the splicing sleeve.
Roll the splicing sleeve between fingers to distribute and extrude excess adhesive.
Wipe away excess adhesive.
" this complaint is confirmed and should be recorded as user related.
The repair is incomplete and shows adhesive voids between the repair oversleeve and catheer tubing.
The stent has migrated from the repair site.
This may have occurred after the catheter was repaired and pressurized.
This appears to be a user technique issue.
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