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

Catalog Number CXI-2.6-18-90-P-NS-ANG

Device Problems Melted (1385); Difficult to Remove (1528)

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

Event Date 03/16/2015

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 cxi was used with a cook micropuncture device and a wire guide from another manufacturer.When the physician tried to take out the wire, it was not possible even with much force.The cxi tore and the physician had to take out all of the products together.It was noted that all 3 products were melted together.However, nothing was lost in the patient's vessel.The investigation further noted that the dilator was melted onto the cxi.There were no reported adverse effects to the patient or additional procedures as a result of this product problem.

• 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: 6990481
• MDR Text Key: 91927818
• Report Number: 1820334-2017-03403
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00827002500020
• UDI-Public: (01)00827002500020(17)171224(10)5541791
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: CXI-2.6-18-90-P-NS-ANG
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2017
• Initial Date FDA Received: 10/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/24/2014
• 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