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

Model Number	N/A
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.
Event or Problem Description
A cxi support catheter was used during multiple procedures.Per a voluntary medwatch (# (b)(4)), it was reported that upon removal of the catheter over an amplatz wire, the luer-lock hub broke off of the device.Additional information has been requested, but has not yet been received.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, drawings, device history record, documentation, manufacturing instructions, and quality control was conducted during the investigation.The complaint device was not returned; therefore, no physical examination could be performed.However, a document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record shows three non-conforming events; however all non-conforming product was scrapped or re-worked prior to completion of the final lot.Based on no product returned, the results of our investigation, and without additional information; a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• 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: 6872010
• Report Number: 1820334-2017-02916
• Device Sequence Number: 19138051
• Product Code: KRA
• UDI-Device Identifier: 00827002525443
• UDI-Public: (01)00827002525443(17)190914(10)7272183
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K072724
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2018

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CXI-4.0-35-150-P-NS-0
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/12/2017
• Supplement Date Received by Manufacturer: 12/28/2017
• Initial Report FDA Received Date: 09/18/2017
• Supplement Report FDA Received Date: 01/11/2018
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 121