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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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, the tip of a cxi support catheter separated.Additional information has been requested.
Event or Problem Description
Additional information was received.The device did not make patient contact.The tip separated as the device was being loaded over a wire guide.The patient did not require any additional procedures and did not experience any adverse effects due to the event.
Additional Manufacturer Narrative
Additional information: b5, h6 (annex e, f, g).Summary of event: as reported, during an unknown procedure, the tip of a cxi support catheter separated.The device did not make patient contact.The tip separated as the device was being loaded over a wire guide.The patient did not require any additional procedures and did not experience any adverse effects due to the event.Investigation evaluation: reviews of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, and quality control procedures were conducted during the investigation.A visual inspection of the complaint device and unused product was also conducted.The complainant returned one prior to use device and nine sealed, unused devices to cook for investigation.The catheter that was opened had a tip length that measured below specification.On the sealed devices, the tip length measured within specification.The sealed devices were loaded on a sample 0.018" wire via the distal tip and again via proximal hub.No tip breakage was noted.A document-based investigation evaluation was performed.One relevant subassembly nonconformance was noted; however, the affected device was scrapped.There have been two additional related complaints on the lot for the same failure mode, reported by the same user facility.The instructions for use (ifu) instructs, ¿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 return device suggests that it is possible that the device was manufactured out of specification and that there are non-conforming devices in-house or in the field.However, due to the nature of the manufacturing process, it is unlikely that the tip deficiency affected the entire lot.Based on the information provided and the results of the investigation, cook has concluded that a manufacturing deficiency at the subassembly level likely contributed to the failure mode.The complaint lot was placed on stop ship and scrapped.Re-training of appropriate personnel has been completed.The risk analysis for the failure mode was reviewed, and it was determined that no escalation actions were 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: 12178209
• Report Number: 1820334-2021-01821
• Device Sequence Number: 13674884
• Product Code: KRA
• UDI-Device Identifier: 00827002565531
• UDI-Public: (01)00827002565531(17)240415(10)13895156
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 01/05/2022

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: 04/15/2024
• Device Model Number: N/A
• Device Catalogue Number: CXI-2.6-18-150-ANG
• Device Lot Number: 13895156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2021
• Supplement Date Received by Manufacturer: 12/16/2021
• Initial Report FDA Received Date: 07/15/2021
• Supplement Report FDA Received Date: 01/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2021
• 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
• Patient Sex: Unknown