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

Model Number N/A

Device Problems Break (1069); Difficult to Advance (2920); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.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 or that a death or serious injury occurred; nor is it admission 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 Description

It was reported that during a lower extremity angiography procedure, a cxi support catheter separated.The physician had obtained left pedal and right groin access.The cxi catheter was then advanced in pedal sheath over another manufacturer's.014 wire and the physician was able to cross the calcified chronic total occlusion of the superficial femoral artery (sfa) with resistance requiring a torque device.However, when the physician attempted to pull out the catheter, it completely separated over the wire.The catheter stayed on the wire and was removed causing no harm to the patient.No additional procedure was needed to treat the lesion.A section of the device did not remain inside the patient.The patient did not require any additional procedures or experience any adverse effects due to the occurrence.

Manufacturer Narrative

Summary of event: it was reported that during a lower extremity angiography procedure, a cxi support catheter separated.The physician had obtained left pedal and right groin access.The cxi catheter was then advanced in pedal sheath over another manufacturer's.014 wire and the physician was able to cross the calcified chronic total occlusion of the superficial femoral artery (sfa) with resistance requiring a torque device.However, when the physician attempted to pull out the catheter, it completely separated over the wire.The catheter stayed on the wire and was removed causing no harm to the patient.No additional procedure was needed to treat the lesion.A section of the device did not remain inside the patient.The patient did not require any additional procedures or experience any adverse effects due to the occurrence.Investigation evaluation: reviews of the instructions for use (ifu) and quality control procedures were conducted during the investigation.A visual inspection was conducted as well.The complaint device was returned to cook for investigation.The returned device showed the catheter was separated into two sections.The first section 83.7cm from the proximal end, and the second section was 67.0cm from the distal end.The shaft separated at approximately 83.7cm from the distal end of the strain relief.Due to the way the catheter was received, several kinks were noted on both sections.A document-based investigation evaluation was performed.Cook could not complete a review of the device history record (dhr) due to lack of lot information from the user facility.A global shipment search for all devices the reporting customer has bought in the past 3 years was performed but could not definitively determine the lot number of the complaint device.At this time, cook could not conclude that nonconforming product from the affected lot exists in house or in the field.Cook also reviewed the product labeling, including the instructions for use (ifu).The customer followed all relevant instructions in the ifu 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 ifu, returned device, and complaint file suggests that there is evidence the device was manufactured to specification.There is no evidence of non-conforming devices in-house or in the field.Based on the information provided and the results of the investigation, cook has concluded that patient anatomy caused 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.

Event 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
• Type of Device: 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: 18783191
• MDR Text Key: 337072192
• Report Number: 1820334-2024-00269
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122796
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/20/2024

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CXI-2.3-14-150-0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2024
• Initial Date FDA Received: 02/26/2024
• Supplement Dates Manufacturer Received: 04/29/2024
• Supplement Dates FDA Received: 05/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: .014 GLIDE ADVANTAGE WIRE