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

Catalog Number CXI-2.6-18-150-P-NS-0

Device Problem Sticking (1597)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/19/2015

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 device was advanced through a 6fr sheath to the lesion of the popliteal artery by contralateral approach.First, the wire guide was advanced through the lesion, then, the cxi advanced over the wire guide, however, the cxi and wire guide got stuck.Therefore, cxi and wire guide were removed together from the patient body, and it was replaced with the same lot # of cxi.No adverse effect to the patient reported.Of note device imaging revealed stretching of the catheter.

• Brand Name: CXI SUPPORT CATHETER
• Type of Device: KRA CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 6987071
• MDR Text Key: 91215967
• Report Number: 1820334-2017-03390
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00827002500013
• UDI-Public: (01)00827002500013(17)180721(10)6048794
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/30/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: CXI-2.6-18-150-P-NS-0
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/27/2017
• Initial Date FDA Received: 10/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1