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

Model Number	N/A
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, prior to use for an unknown procedure, a few millimeters of a cxi support catheter's tip separated during preparation of the device.Another cxi catheter was used to successfully complete the procedure.The patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.E1: name and address: phone, postal code: (b)(6).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
Corrected information: h6 (annex a) summary of event: as reported, prior to use for an unknown procedure, a few millimeters of a cxi support catheter's tip separated during preparation of the device.Another cxi catheter was used to successfully complete the procedure.The patient did not experience any adverse effects or require any additional procedures due to this occurrence.Investigation evaluation: reviews of the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions, and quality control procedures were conducted during the investigation.A visual inspection and dimensional verification of the complaint device was also conducted.The complaint device was returned to cook for investigation.The tip was separated.The separated tip measured 4-millimeters and the remaining tip, still attached to the catheter, also measured 4-millimeters.Two kinks were also noted on the catheter.A document-based investigation evaluation was performed.A review of the device history record found no relevant non-conformances on the final lot.Four relevant non-conformances were noted on sub-assembly lots, on four devices; however, all affected product was scrapped.A review of complaint history found no additional relevant complaints for this lot number.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.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.Although four relevant non-conformances were noted on sub-assembly lots, all non-conforming product was scrapped, there are 100% inspections in place to capture this non-conformance, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot-related complaints have been received from the field.Therefore, it was concluded that there is no evidence that additional non-conforming product exists in-house or in the field.Based on the information provided and the results of the investigation, cook has concluded that a manufacturing deficiency contributed to this event.Responsible personnel were notified.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 regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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: 18495849
• Report Number: 1820334-2024-00062
• Device Sequence Number: 3690677
• Product Code: KRA
• UDI-Device Identifier: 00827002231634
• UDI-Public: (01)00827002231634(17)260907(10)15644021
• Combination Product (Y/N): N
• 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
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2024

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: 09/07/2026
• Device Model Number: N/A
• Device Catalogue Number: CXI-2.6-18-135-ANG
• Device Lot Number: 15644021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/19/2023
• Supplement Date Received by Manufacturer: 03/28/2024
• Initial Report FDA Received Date: 01/11/2024
• Supplement Report FDA Received Date: 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2023
• 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