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

Catalog Number	CXI-2.6-18-90-P-NS-ANG
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/16/2015
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 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
• Common Device Name: KRA CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6990481
• Report Number: 1820334-2017-03403
• Device Sequence Number: 1353380
• Product Code: KRA
• UDI-Device Identifier: 00827002500020
• UDI-Public: (01)00827002500020(17)171224(10)5541791
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 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-2.6-18-90-P-NS-ANG
• 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