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

Model Number	G56550
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: phone number: (b)(6).H3: device evaluation anticipated, but not yet begun.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 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
As reported, prior to a percutaneous transluminal angioplasty (pta), the cxi support catheter's package was discovered to be unsealed when the user attempted to open it.The user utilized a new same type of device to 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, unchanged, or unavailable.Summary of event: as reported, prior to a percutaneous transluminal angioplasty (pta), the cxi support catheter's package was discovered to be unsealed when the user attempted to open it.The user utilized a new same type of device to 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), 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 package was unsealed.A document-based investigation evaluation was performed.A review of the device history record found no relevant non-conformances on the lot.A review of complaint history found no additional 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, and investigation of the returned device suggests that there is evidence the device was manufactured out of specification; however, 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 and quality control deficiency contributed to this event.The 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.

• 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: 22068944
• Report Number: 1820334-2025-00580
• Device Sequence Number: 8712147
• Product Code: KRA
• UDI-Device Identifier: 00827002565500
• UDI-Public: (01)00827002565500(17)280303(10)16489664
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2025

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: G56550
• Device Catalogue Number: CXI-2.6-18-90-0
• Device Lot Number: 16489664
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2025
• Supplement Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2025
• 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