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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2021
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, upon opening the package of a cxi support catheter, the tip of the catheter separated after the device was pulled from the holder and a finger was ran along the tip.The device was not intended to be used during any procedure and did not make contact with any patient.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: e1, e3.E3: occupation= lab manager.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.
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 unchanged, unknown, or unavailable.Event summary as reported, upon opening the package of a cxi support catheter, the tip of the catheter separated after the device was pulled from the holder and a finger was ran along the tip.The device was not intended to be used during any procedure and did not make contact with any patient.Investigation - evaluation a document-based investigation was performed including a review of complaint history, device history record (dhr), drawing, manufacturing instructions, quality control data, and the instructions for use (ifu).Interviews with personnel were also conducted.The complainant did not return the complaint device associated with this incident to cook for investigation, therefore, no physical examinations could be performed.In response to this incident, cook completed a review of the dhr.Complaint device lot, which records no non-conformances, was manufactured with a subassembly lot.The subassembly lot records one relevant non-conformance for "npbx out of tolerance" in 1 device, which was scrapped.A data base search showed that the subassembly lot was applied to 3 other final lots, none of which have relevant non-conformances or complaints from the field.A database search for complaints on the reported lot found 2 additional related complaints from the field reported for the same failure mode by the same user facility.At this time, cook concluded that no non-conforming product from this lot exists in house or in the field.At this time, cook concluded that the recorded non-conformance on subassembly lot was likely related to this incident.Communication with production revealed that incorrect tolerance or placement of the distal npbx and nytt materials during lamination prep can lead to insufficient overlap or gaps between the pieces, which weakens the tip integrity and can result in bends or breakage.In response to this conclusion, the complaint lot was placed on containment, and the applicable operators were retrained to the applicable steps on 16nov2021.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.¿ a clinical assessment was completed and concluded: separation of catheter segments into the vascular system during a procedure can result in migration of the segment to a vital structure or organ, resulting in reduced blood flow to the affected area and requiring additional intervention(s) to prevent permanent harm.In this case, the separation occurred prior to patient contact, upon opening the package.With current information, the cause for this event could possibly be traced to manufacturing or shipping/transport/storage/handling issues.Cook has concluded that a manufacturing deficiency at the subassembly level likely contributed to this incident.Per the quality engineering risk assessment, no further action is warranted.Cook medical will continue to monitor this device via the complaints database for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or 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 ; 8128294891
• MDR Report Key: 12180154
• Report Number: 1820334-2021-01823
• Device Sequence Number: 3298731
• Product Code: KRA
• UDI-Device Identifier: 00827002565531
• UDI-Public: (01)00827002565531(17)240415(10)13895156
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 12/15/2021

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: Other
• 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?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/02/2021
• Supplement Date Received by Manufacturer: 08/03/2021; 12/14/2021
• Initial Report FDA Received Date: 07/16/2021
• Supplement Report FDA Received Date: 08/19/2021; 12/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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