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

Catalog Number	CXI-2.6-18-150-P-NS-0
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/05/2015
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.Six similar complaints found within the scope of (b)(4), including this one, were identified and compared.These six complaints do not share consistent commonalities; the individual investigations did not include material analysis of the components or returned particulate matter; and the returned devices were not retained.Patient factors were ruled out as a contributing element.No similar complaints were found in the database after may 2016.Refer to similar mdrs submitted as part of (b)(4): 1820334-2017-03405, 1820334-2017-03407, 1820334-2017-03408, 1820334-2017-03392, and 1820334-2017-03844.
Event or Problem Description
Approach was gained from the common femoral artery (cfa) contralaterally.The device was advanced with the aid of another manufacturer's wire guide to pass through the lesion, but torque applied to the wire guide would not transmit.The physician removed the devices and applied torque to the wire guide at proximal site to test the torque transmission, but the wire guide tip still would not respond.Moreover, when the catheter was flushed after the issue, metal-like substances came out from inner lumen.Another catheter was used to finish the procedure, and there were no patient injuries reported.

• 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: 7006740
• Report Number: 1820334-2017-03843
• Device Sequence Number: 977275
• Product Code: KRA
• UDI-Device Identifier: 00827002500013
• UDI-Public: (01)00827002500013(17)180622(10)5974939
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/07/2017

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-2.6-18-150-P-NS-0
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2017
• Initial Report FDA Received Date: 11/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1