It was reported the catheter was placed successfully with the use of vps and a blue bullseye was obtained.Upon removal, slight resistance was met when retracting the biosensor from the picc.When the biosensor was completely out, the very tip appeared to be damaged with the wire separated from the sensor but remained intact.There was no patient death or complications reported.
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(b)(4).It was reported the catheter was placed successfully with the use of vps and a blue bullseye was obtained.Upon removal, slight resistance was met when retracting the biosensor from the picc.When the biosensor was completely out, the very tip appeared to be damaged with the wire separated from the sensor but remained intact.The issue was confirmed.One vps biosensor stylet was returned.Visual examination at 20x magnification revealed that the transducer was missing from the end of the stylet.It appears that the transducer had been properly attached and was separated by excessive force.The stylet graphic specifies the outside diameter of the transducer encapsulation at.0185 /.0195 inches.No measurement could be made because of the condition of the returned stylet.The instruction booklet provided with the bedside kit, states that arrow vps stylets are designed to be used with catheters with a minimum inner lumen diameter of.021 inches.It was reported that the vps stylet was being used with a double-lumen bioflo picc.Information on the angiodynamics directions for use indicate that their bioflo picc catheters have a maximum other remarks: guidewire compatibility of.018 inches.It appears that the bioflo catheter used in the procedure may not be suitable for use with a vps stylet.A device history record review was performed on the stylet and did not reveal any manufacturing related issues.Use error caused or contributed to this event.A customer in-service has been initiated for this issue.
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