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

Model Number	G18373
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.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, while attempting to cross a chronic total occlusion in the anterior tibial artery, a cxi support catheter separated in half upon removal of the device.The cxi catheter was advanced through another cook catheter and 5-french sheath, over a cook wire, via an ipsilateral approach.The anatomy was calcified, and resistance was encountered during advancement of the catheter, as the chronic total occlusion (cto) was ¿challenging¿ to cross.A power injector was not used.The separated catheter fragment was removed manually from the patient, and balloons and an intravascular lithotripsy device were used to treat the lesion.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures or experience any adverse effects due to this event.
Additional Manufacturer Narrative
Summary of event: as reported, while attempting to cross a chronic total occlusion in the anterior tibial artery, a cxi support catheter separated in half upon removal of the device.The cxi catheter was advanced through another cook catheter and 5-french sheath, over a cook wire, via an ipsilateral approach.The anatomy was calcified, and resistance was encountered during advancement of the catheter, as the chronic total occlusion (cto) was ¿challenging¿ to cross.A power injector was not used.The separated catheter fragment was removed manually from the patient, and balloons and an intravascular lithotripsy device were used to treat the lesion.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures or experience any adverse effects due to this event.Corrected information: d4 (udi).Investigation evaluation: reviews of the complaint history, device history record (dhr), instructions for use (ifu), 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 catheter was separated into two sections.The catheter separated approximately 57.9-centimeters from the strain relief.The second segment measured approximately 94-centimeters in length.A document-based investigation evaluation was performed.A review of the device history record and complaint history found no relevant discrepancies or additional complaints on the lot.The product ifu cautions ¿the catheter should not be advanced through an area of resistance unless source of resistance is identified by fluoroscopy and appropriate steps are taken to reduce or remove the obstruction.¿ 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 to specification.Based on the information provided and the results of the investigation, cook has concluded that the patient¿s calcified anatomy contributed to this event.Reportedly, the user encountered resistance during advancement of the device, and the chronic total occlusion was ¿challenging¿ to cross.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: 23357706
• Report Number: 1820334-2025-01292
• Device Sequence Number: 8871583
• Product Code: KRA
• UDI-Device Identifier: 00827002183735
• UDI-Public: (01)00827002183735(17)280808(10)16732660
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2026

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: G18373
• Device Catalogue Number: CXI-2.3-14-150-0
• Device Lot Number: 16732660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2025
• Supplement Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: COOK 5FR X 45CM FLEXOR ANSEL SHEATH.; COOK APPROACH HYDRO ST WIRE.; COOK KMP CATHETER.; SERENITY BALLOONS.; SHOCKWAVE DEVICE.
• Patient Sex: Male