(b)(4).
Device evaluation: the report that the catheter was difficult to insert through the sheath, which resulted in a punctured myocardium was not confirmed.
One edwards swan ganz cco/mbo/vip 1.
5 ml cap 746f8 catheter inserted through a cath-gard contamination shield was returned.
The psi sheath involved in the incident was not returned.
During microscopic inspection of the catheter, the balloon appeared to be intact; however, it would not inflate.
The catheter body was measured at 2.
76 mm.
The edwards website indicates that the catheter is 8 fr.
Per the lidstock, the arrow sheath/cath-gard is designed for use with 7.
5 - 8 fr catheters.
The catheter was removed from the cath-gard and reinserted with some resistance encountered at the cath-gard hubs.
A device history record review was performed and did not reveal any manufacturing related issues.
A risk evaluation was completed for this complaint.
The probable cause of this issue could not be performed based on the information provided and without a complete sample.
No further action will be taken.
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