Catalog Number CXI-2.3-14-150-0 |
Device Problems
Break (1069); Difficult to Remove (1528); Failure to Advance (2524)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 07/30/2015 |
Event Type
malfunction
|
Manufacturer Narrative
|
This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
|
|
Event Description
|
The following information was reported: an arteriogram on the right leg with left groin access was being performed.The physician was placing the vertebral catheter (vert) through a 6f sheath that was placed up and over the aortic bifurcation and got into position.The cxi support catheter was placed through the vertebral catheter when resistance was met.It was thought that the resistance was at the tip where the vert takes an angle.The physician had to pull the vert back over the bifurcation and put the cxi all the way down, then advance the vert over the cxi (an extra step because the cxi wouldn't advance through the vert).The physician then attempted to take the wire (cto wire) out of the cxi and it would not remove from the cxi.He tried to back the cxi off the wire to take it out feeling the cxi was the issue and it wouldn't come out.He pulled so much that the cxi broke.The cxi and wire had to be removed together.This caused the physician to lose his wire access down the leg and he opted to stick from the foot to treat the patient.It was further noted that the catheter was severed in two places (3 mm from the hub and 18.5 cm from the first separation).The procedure was completed through pedal access.No sections of the device remained inside the patient's body and the patient did not require any additional procedures as a result of the product problem.
|
|
Search Alerts/Recalls
|