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

Catalog Number	CXI-4.0-35-90-P-NS-DAV
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/01/2023
Type of Reportable Event	Serious Injury
Additional 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, 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 fenestrated endovascular repair procedure, a cxi support catheter separated.The catheter was reportedly inserted into an aortic graft that was already in situ, resulting in separation of the distal portion of the catheter, which was retained in the patient.The patient was sent to interventional radiology for further surgery at a later time, where the catheter was successfully removed with a snare.Additional information has been requested.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, during a fenestrated endovascular repair procedure, a cxi support catheter separated.The catheter was reportedly inserted into an aortic graft that was already in situ, resulting in separation of the distal portion of the catheter, which was retained in the patient.The patient was sent to interventional radiology for further surgery at a later time, where the catheter was successfully removed with a snare.Investigation evaluation: reviews of the complaint history, device history record, instructions for use (ifu), and quality control procedures were conducted during the investigation.The complaint device was not returned to cook for investigation.A document-based investigation evaluation was performed.A review of the device history record found no non-conformances on the lot.A review of complaint history found no additional complaints for this lot number.The product ifu states ¿the catheter should not be advanced through an area of resistance unless the source of the resistance is identified under fluoroscopy and appropriate steps are taken to reduce or remove the obstruction.¿ the ifu also states ¿the catheter should not be advanced into a vessel having a reference vessel diameter smaller than the catheter outer diameter.¿ the information provided upon review of the dmr, dhr, and ifu 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.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the information provided and the results of the investigation, cook has concluded that procedural issues contributed to this event.Per the reporter, insertion of the catheter into a pre-existing aortic graft resulted in separation of the distal portion of the catheter.It is possible that the catheter became caught on or in the graft material, leading to separation; however, this cannot be confirmed.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: 17641863
• Report Number: 1820334-2023-01166
• Device Sequence Number: 20231677
• Product Code: KRA
• UDI-Device Identifier: 00827002525474
• UDI-Public: (01)00827002525474(17)260301(10)15247998
• Combination Product (Y/N): N
• PMA/510(K) Number: K160884
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2023

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 Expiration Date: 03/01/2026
• Device Catalogue Number: CXI-4.0-35-90-P-NS-DAV
• Device Lot Number: 15247998
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/14/2023
• Supplement Date Received by Manufacturer: 11/10/2023
• Initial Report FDA Received Date: 08/29/2023
• Supplement Report FDA Received Date: 12/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown