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

Model Number	G23160
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, a small piece of the distal tip of a cxi support catheter separated prior to being used in the patient.The user had difficulty advancing the device onto the wire when they noticed the separated tip.The device did not make patient contact.The procedure was successfully completed with a replacement device.No unintended section of the device remained inside of the patient's body.No additional procedures were required due to the occurrence.No adverse effects were reported due to the occurrence.
Additional Manufacturer Narrative
Initial reporter occupation: respiratory therapist.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Additional Manufacturer Narrative
Summary of event: as reported, a small piece of the distal tip of a cxi support catheter separated prior to being used in the patient.The user had difficulty advancing the device onto the wire when they noticed the separated tip.The device did not make patient contact.The procedure was successfully completed with a replacement device.No unintended section of the device remained inside of the patient's body.No additional procedures were required due to the occurrence.No adverse effects were reported due to the occurrence.Investigation evaluation: reviews of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, and quality control procedures were conducted during the investigation.A visual inspection of the complaint device was also conducted.The complaint device was returned to cook for investigation.The separated section of the tip was four millimeters, and the portion still attached to the catheter was five millimeters.A document-based investigation evaluation was performed.No related non-conformances were found, and there have been no other reported complaints for this lot number.The product ifu states, ¿upon removal from package, inspect product to ensure no damage has occurred.¿ the information provided upon review of the dmr, dhr, ifu, and investigation of the returned device suggests that there is evidence the device was manufactured out of specification; however, there is no evidence of additional non-conforming devices in-house or in the field.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the information provided and the results of the investigation, cook has concluded that a manufacturing/quality control deficiency contributed to this incident.The risk analysis for this failure mode was reviewed and no additional escalation was required.The appropriate personnel have been notified and cook will continue to monitor for similar events.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No additional information has been received since the last report was submitted.

• Brand Name: CXI SUPPORT CATHETER
• Common Device Name: KRA CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC.; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 15008470
• Report Number: 1820334-2022-01203
• Device Sequence Number: 6857043
• Product Code: KRA
• UDI-Device Identifier: 00827002231603
• UDI-Public: (01)00827002231603(17)250501(10)14700322
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K122796
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2022

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 Expiration Date: 05/01/2025
• Device Model Number: G23160
• Device Catalogue Number: CXI-2.3-14-135-0
• Device Lot Number: 14700322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/28/2022
• Supplement Date Received by Manufacturer: 10/05/2022
• Initial Report FDA Received Date: 07/13/2022
• Supplement Report FDA Received Date: 10/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown