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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during an unspecified procedure involving left pedal access to target the anterior tibial artery, the tip of a cxi support catheter separated.The device was flushed and wiped down with heparinized saline.The catheter was advanced over another manufacturer's 0.018-inch wire guide; however, before the catheter entered the sheath or the patient, the tip kinked and separated.The procedure was successfully completed with another device of the same type.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Initial reporter occupation = lead tech.Device evaluated by mfg = other (81) - 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 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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, during an unspecified procedure involving left pedal access to target the anterior tibial artery, the tip of a cxi support catheter separated.The device was flushed and wiped down with heparinized saline.The catheter was advanced over another manufacturer's 0.018-inch wire guide; however, before the catheter entered the sheath or the patient, the tip kinked and separated.The procedure was successfully completed with another device of the same type.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Corrected information: h6 (annex g).Investigation evaluation: reviews of the complaint history, device history record, drawings, instructions for use (ifu), 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.Approximately four millimeters of the tip remained on the catheter.The separated portion of the tip was not returned.A document-based investigation evaluation was performed.No related non-conformances were found, and there have been no other reported complaints for this lot number.The instructions for use states "activate hydrophilic coating by wetting the catheter with heparinized saline solution or sterile water.To ensure hydrophilic activation, wet entire surface of catheter." it further states "upon removal from package, inspect the product to ensure no damage has occurred." cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the returned product indicates the device was manufactured out of specification.However, a review of the dmr, ifu, and dhr does not show evidence of additional nonconforming product in house or in the field.Based on the available information and results of the investigation, cook has concluded that a manufacturing deficiency 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: 16920061
• Report Number: 1820334-2023-00591
• Device Sequence Number: 6805224
• Product Code: KRA
• UDI-Device Identifier: 00827002565531
• UDI-Public: (01)00827002565531(17)250103(10)14448655
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2023

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 Expiration Date: 01/03/2025
• Device Model Number: G56553
• Device Catalogue Number: CXI-2.6-18-150-ANG
• Device Lot Number: 14448655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/24/2023
• Supplement Date Received by Manufacturer: 07/26/2023
• Initial Report FDA Received Date: 05/12/2023
• Supplement Report FDA Received Date: 08/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2022
• 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: ABBOTT COMMAND 0.018 WIRE
• Patient Age: 78 YR
• Patient Sex: Female