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

Model Number	G23861
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.H3: device evaluated by mfg - device evaluation has begun; however, a conclusion is not yet available.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.
Event or Problem Description
As reported, during an angioplasty of the tibial arteries via contralateral access in the common femoral artery, a cxi support catheter separated.The catheter was advanced through a cook 5-french, 90-centimeter ansel sheath, over another manufacturer¿s 0.014-inch wire guide.The anatomy was not stenosed, tortuous, or calcified.Resistance was not encountered upon insertion or advancement of the catheter.Toward the end of the procedure, the catheter separated between the hub and catheter.A power injector was not used with the device.The user reportedly then cut the catheter with a blade to maintain wire access, and the catheter was replaced with another catheter to successfully complete the procedure.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.The device was returned to cook on 10feb2025.Photos show that the device was separated just below the hub.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, during an angioplasty of the tibial arteries via contralateral access in the common femoral artery, a cxi support catheter separated.The catheter was advanced through a cook 5-french, 90-centimeter ansel sheath, over another manufacturer¿s 0.014-inch wire guide.The anatomy was not stenosed, tortuous, or calcified.Resistance was not encountered upon insertion or advancement of the catheter.Toward the end of the procedure, the catheter separated between the hub and catheter.A power injector was not used with the device.The user reportedly then cut the catheter with a blade to maintain wire access, and the catheter was replaced with another catheter to successfully complete the procedure.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.The device was returned to cook on 10feb2025.Photos show that the device was separated just below the hub.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 of the complaint device was conducted as well.The complaint device was returned to cook for investigation.There were kinks through the length of the device and the catheter tubing was separated at the strain relief.A document-based investigation evaluation was performed.A review of the device history record found one relevant non-conformance on four devices for the final lot and one relevant non-conformance on two devices for the catheter component lot; however, all non-conforming product was scrapped prior to release and there are 100% inspections in place to capture the non-conformance.A review of complaint history found no additional relevant complaints for this lot number.The relevant component lot was used in one other final lot.A complaint history search on this lot found no relevant complaints.The product ifu was reviewed, and the customer followed all relevant instructions related to this failure.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 to specification.Although there were relevant non-conformances found in the final lot, and component lots, all non-conforming product was scrapped prior to release and there are 100% inspections in place to capture this non-conformance.No other lot related complaints have been received from the field.Adequate inspection activities have been established.At this time, cook has concluded that no non-conforming product from this lot exists in house or in the field.Based on the information provided and the results of the investigation, cook has concluded that component failure, unrelated to manufacturing or design deficiencies, 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.

• 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: 21423630
• Report Number: 1820334-2025-00155
• Device Sequence Number: 20829783
• Product Code: KRA
• UDI-Device Identifier: 00827002238619
• UDI-Public: (01)00827002238619(17)271113(10)16338289
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2025

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: G23861
• Device Catalogue Number: CXI-2.3-14-150-ANG2
• Device Lot Number: 16338289
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2025
• Supplement Date Received by Manufacturer: 05/22/2025
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2024
• 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: "SERENITY"; 014" GLIDEWIRE ADVANTAGE
• Patient Sex: Unknown