The report rec'd from the field indicated that the 55 y/o male was undergoing a percutaneous transluminal coronary angioplasty procedure.
The catheter sheath introducer was inserted into the right femoral vein.
An 8fr catheter sheath introducer was inserted in the right femoral artery.
Upon completion of the procedure, the catheter sheath introducer (6fr) was withdrawn by the nurse while maintaining groin pressure, following removal of the 8fr catheter sheath introducer.
Inspection of the catheter sheath introducer revealed that the distal portion of the catheter sheath introducer had remained in vivo in the right common femoral vein.
During attempts to recover the distal portion of the catheter sheath introducer with a snare, it migrated to the inferior right pulmonary artery.
The catheter sheath introducer portion was successfully retrieved using a snare with no report of pt injury or complications.
The following analysis has been performed on the returned product: visual examination: the catheter sheath introducer was within a plastic bag.
The distal most 6.
5cm of the cannula had torn off leaving the remaining 4.
5cm attached to the sheath's hub.
Light optical examination: examination revealed the fractured ends to be frayed and elongated.
This condition was duplicated in the product performance lab by slightly bending the cannula and inserting and forcing a vessel dilator through the cannula wall.
The distal end of the cannula was held with one hand while pulling onto the catheter sheath introducer with the other.
The cannula separated and exhibited a condition very similar to the returned product.
It is hypothesized that, upon insertion of the sheath into the groin, the cannula kinked and folded back onto itself.
During attempts to insert a vessel dialator through the sheath, the dilator tip punctured the cannula wall.
Upon insertion, the catheter guidewire tip went through the puncture that had previously been created by the vessel dialator.
As the catheter was being withdrawn, the folded distal portion of the catheter sheath introducer fractured and remained inside the groin.
Device history lot: this is the first complaint rec'd for this lot number.
No device defect or malfunction has been identified.
The clinical event has been attributed to user error.
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