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

Model Number	G18371
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, while placing a cxi support catheter over a wire the radiopaque tip of the support catheter separated from the rest of the device.The target access site was the groin, and we were using a hydro st.The marker separated while on the wire.The device did not make patient contact.When the user noticed the issue, they removed the catheter and replaced with another device of the same type.No unintended section of the device remained inside of the patient's body.No additional procedures were required due to the occurrence.No adverse effects were reported due to the occurrence.
Additional Manufacturer Narrative
Occupation: lead tech.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
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, while placing a cxi support catheter over a wire the radiopaque tip of the support catheter separated from the rest of the device.The target access site was the groin, and we were using a hydro st.The marker separated while on the wire.The device did not make patient contact.When the user noticed the issue, they removed the catheter and replaced with another device of the same type.No unintended section of the device remained inside of the patient's body.No additional procedures were required due to the occurrence.No adverse effects were reported due to the occurrence.Corrected information: h6 (annex a and g).Investigation evaluation: reviews of the complaint history, device history record, drawings, instructions for use (ifu), personnel interviews, and quality control procedures were conducted during the investigation.A visual inspection and dimensional verification of the complaint device was also conducted.The complainant returned one cxi support catheter to cook for investigation.The tip of the catheter was frayed and measured 4 mm.Cook completed a review of the device history record (dhr).The dhr for the reported lot found no relevant non-conformances.Cook complete a document review.The document review confirmed that adequate manufacturing specifications, operation parameters, and the design verification testing of the device are in place to identify and prevent this failure mode prior to distribution.The instructions for use (ifu) provides the following information to the user related to the reported failure mode: how supplied upon removal from package, inspect the product to ensure no damage has occurred.Examination of the returned device, as well as communication with production, suggests that it is possible that the complaint device was manufactured out of specification.Cook has concluded that a manufacturing deficiency at the subassembly level likely contributed to this incident.The applicable operators were retrained to the applicable steps to prevent this failure from occurring again in the future.The appropriate personnel have been notified and cook will continue to monitor for similar events.Per the quality engineering risk assessment, no further action is required.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: 13713910
• Report Number: 1820334-2022-00371
• Device Sequence Number: 20322800
• Product Code: KRA
• UDI-Device Identifier: 00827002183711
• UDI-Public: (01)00827002183711(17)230827(10)13393414
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K122796
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2022

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: 08/27/2023
• Device Model Number: G18371
• Device Catalogue Number: CXI-2.3-14-90-0
• Device Lot Number: 13393414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2022
• Supplement Date Received by Manufacturer: 04/15/2022
• Initial Report FDA Received Date: 03/09/2022
• Supplement Report FDA Received Date: 04/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2020
• 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
• Patient Sex: Unknown