MAUDE Adverse Event Report: COOK INCORPORATED CXI; CATHETER, CONTINUOUS FLUSH

Model Number	G50003
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/07/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Cxi support cath ref g5003.When trying to dilate a vessel in the leg the catheter broke inside about a 3-4 inch piece.It was able to be retrieved.It is a cook medical product.The package and the device were saved.

• Brand Name: CXI
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7629004
• Report Number: 7629004
• Device Sequence Number: 1899301
• Product Code: KRA
• UDI-Device Identifier: 00827002500037
• UDI-Public: (01)00827002500037(17)200410(10)7815407
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/18/2018
• Report Date (Section F): 06/18/2018

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: Physician
• Device Expiration Date: 04/10/2020
• Device Model Number: G50003
• Device Catalogue Number: CXI-2.6-18-150-P-NS-ANG
• Device Lot Number: 7815407
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 06/18/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 87 YR
• Patient Weight: 63
• Date Report Sent to FDA: 06/18/2018