MAUDE Adverse Event Report: COOK INC CXI SUPPORT CATHETER; KRA CATHETER, CONTINUOUS FLUSH

Catalog Number	CXI-2.3-14-150-0
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/30/2015
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.

• Brand Name: CXI SUPPORT CATHETER
• Common Device Name: KRA CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6991450
• Report Number: 1820334-2017-03411
• Device Sequence Number: 1293117
• Product Code: KRA
• UDI-Device Identifier: 00827002183735
• UDI-Public: (01)00827002183735(17)180615(10)5957254
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: CXI-2.3-14-150-0
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2017
• Initial Report FDA Received Date: 10/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1