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

Catalog Number G52544

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 08/10/2017

Event Type  malfunction  

Event Description

A cxi support catheter 150cm in length got stuck going over an 0.035" amplatz wire, so stuck, the luer-lock hub from one end of the catheter broke off trying to remove it over-the-wire.

• Brand Name: CXI SUPPORT CATHETER
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): COOK, INC.; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6841403
• MDR Text Key: 84640584
• Report Number: 6841403
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/17/2017

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: Physician
• Device Catalogue Number: G52544
• Device Lot Number: 7272183
• Other Device ID Number: CXI-4.0-35-150-P-NS-0
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/17/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 08/17/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: A CXI SUPPORT CATHETER 150CM IN LENGTH GOT STUCK G
• Patient Age: 68 YR
• Patient Weight: 121