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

Model Number	G56553
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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, during a right lower extremity angiogram, the tip of a cxi support catheter separated as the catheter was pushed down the superficial femoral artery (sfa).Per the reporter, the tip broke off within the proximal sfa, before reaching the lesion.The separated fragment was stented against the vessel wall and remains in the patient.Per the reporter, the patient is "doing well".The patient did not require any additional procedures or experience any adverse effects due to this event.Additional information has been requested.
Additional Manufacturer Narrative
Additional information: b3, b5, d10.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
Additional information was received 19aug2025.Access was obtained in the left common femoral artery for a contralateral approach.Resistance was not encountered during insertion or advancement of the catheter through another manufacturer¿s sheath and over another manufacturer¿s wire.Two-to-three centimeters of the catheter tip separated.Per the reporter, the catheter did not reach the calcified and stenosed lesion within the distal superficial femoral and popliteal arteries prior to tip separation.A power injector was not used.The procedure was completed successfully.
Additional Manufacturer Narrative
Summary of event: as reported, during a right lower extremity angiogram, the tip of a cxi support catheter separated as the catheter was pushed down the superficial femoral artery (sfa).Per the reporter, the tip broke off within the proximal sfa, before reaching the lesion.The separated fragment was stented against the vessel wall and remains in the patient.Per the reporter, the patient is "doing well".The patient did not require any additional procedures or experience any adverse effects due to this event.Additional information was received 19aug2025.Access was obtained in the left common femoral artery for a contralateral approach.Resistance was not encountered during insertion or advancement of the catheter through another manufacturer¿s sheath and over another manufacturer¿s wire.Two-to-three centimeters of the catheter tip separated.Per the reporter, the catheter did not reach the calcified and stenosed lesion within the distal superficial femoral and popliteal arteries prior to tip separation.A power injector was not used.The procedure was completed successfully.Corrected information: d4 (udi).Investigation evaluation: reviews of the complaint history, device history record (dhr), instructions for use (ifu), drawing, 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 catheter tip was separated.No other damage was noted.A document-based investigation evaluation was performed.A review of the device history record and complaint history found no discrepancies or additional relevant complaints on the final or sub-assembly lots.The product ifu instructs the user not to advance the catheter through an area of resistance unless the source of resistance is identified by fluoroscopy and appropriate steps are taken to reduce or remove the obstruction.The ifu cautions that the catheter should not be advanced into a vessel having a reference vessel diameter smaller than the outer diameter of the catheter.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 a component failure, unrelated to manufacturing or design deficiencies, contributed to this event.Resistance was not encountered during insertion or advancement of the catheter through another manufacturer¿s sheath and over another manufacturer¿s wire.The tip broke off within the proximal sfa, before reaching the calcified and stenosed lesion within the distal superficial femoral and popliteal arteries.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: 22841119
• Report Number: 1820334-2025-01019
• Device Sequence Number: 11993625
• Product Code: KRA
• UDI-Device Identifier: 00827002565531
• UDI-Public: (01)00827002565531(17)270830(10)16231062
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 01/14/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: G56553
• Device Catalogue Number: CXI-2.6-18-150-ANG
• Device Lot Number: 16231062
• 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: 08/13/2025
• Supplement Date Received by Manufacturer: 08/19/2025; 12/22/2025
• Initial Report FDA Received Date: 08/19/2025
• Supplement Report FDA Received Date: 08/21/2025; 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2024
• 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: 0.014 TERUMO GLIDEWIRE ADVANTAGE.; 6X55 TERUMO DESTINATION SHEATH.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown