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

Model Number	G18373
Medical Device Problem Codes	Break (1069); Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter occupation: occupation = inventory manager.Pma/510(k) number = although the exact rpn is unknown, the possible 510(k)s are k122796 or k160884.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
As reported, during an unknown procedure, a cxi support catheter separated prior to use.The user attempted to flush the device, however, the catheter would not flush.The user advanced a wire to clear the device, and a residue reportedly came out of the catheter, which then separated.Another cxi of the same type was used to finish the procedure, with no further complications.There have been no adverse effects to the patient reported.
Event or Problem Description
Information was available and inadvertently omitted from the previous report.Upon return and evaluation of the device, the catheter was not separated as originally reported.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, during an unknown procedure, a cxi support catheter separated prior to use.The user attempted to flush the device, however, the catheter would not flush.The user advanced a wire to clear the device, and a residue reportedly came out of the catheter, which then separated.Another cxi of the same type was used to finish the procedure, with no further complications.There have been no adverse effects to the patient reported.Investigation evaluation: reviews of the complaint history, device history record, drawing, instructions for use (ifu), and quality control procedures were conducted during the investigation.A visual inspection, dimensional verification, and functional test of the complaint device was also conducted.The complaint device was returned to cook.The device was not separated as originally reported; however, the device was unable to be flushed.A wire guide was unable to advance past the hub of the device.Additional testing was performed, using underwater ultrasound, at which point a wire was able to be passed through from the hub to the distal tip of the catheter, dislodging green material.The device was then able to be flushed.A document-based investigation evaluation was performed.There have been no other reported complaints for this lot number.One relevant non-conformance was noted on a subassembly lot; however, all affected product was scrapped, and 100% inspections are in place to identify the non-conformance.The product ifu states, ¿upon removal from package, inspect the product to ensure no damage has occurred.¿ the information provided upon review of the dmr, dhr, ifu, and investigation of the returned device suggests that there is evidence the device was manufactured out of specification; however, as there have been no additional complaints from the field, all non-conforming product was scrapped, and 100% inspections are in place, there is no evidence of additional non-conforming devices in-house or in the field.Cook has 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 a manufacturing/quality control deficiency contributed to this event.Defect awareness training has been completed by the responsible personnel.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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: d4, d9, d10, g4, h3 h3: 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 information regarding the patient or event has been received since the last report was submitted.

• 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: 13968978
• Report Number: 1820334-2022-00506
• Device Sequence Number: 4911384
• Product Code: KRA
• UDI-Device Identifier: 00827002183735
• UDI-Public: (01)00827002183735(17)241007(10)14261189
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/11/2022

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: 10/07/2024
• Device Model Number: G18373
• Device Catalogue Number: CXI-2.3-14-150-0
• Device Lot Number: 14261189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/23/2022
• Supplement Date Received by Manufacturer: 04/01/2022; 07/25/2022
• Initial Report FDA Received Date: 03/31/2022
• Supplement Report FDA Received Date: 04/26/2022; 08/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2021
• 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 .014X300CM
• Patient Sex: Unknown