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

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

Device Problem Tip breakage (1638)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

The customer had an issue with the cxi support catheter.No date given.Customer stated "the other day" so this happened prior to (b)(6) 2014.Customer was unable to remove the cxi support catheter from the wire and in the process of removing it, the tip came adrift.The tip stayed on the wire and was safely removed from the patient's artery.No additional information has been provided by the reporter.

Manufacturer Narrative

Event evaluation: still under investigation.

• Brand Name: CXI SUPPORT CATHETER
• Manufacturer (Section D): COOK, INC.; bloomington IN 47402
• Manufacturer Contact: rita harden, dir ; 750 daniels way; bloomington, IN 47404 ; 23392235
• MDR Report Key: 3818810
• MDR Text Key: 4498401
• Report Number: 1820334-2014-00039
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K072724
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: CXI-2.6-18-150-P-NS-0
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 01/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1