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

Model Number	G56552
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported, during an unspecified procedure, the tip of a cxi support catheter separated.Another manufacturer's wire was placed via femoral access for a contralateral approach; however, the wire would not advance, and therefore the physician removed the wire and obtained pedal access.The user then removed the complaint device from the package to place it over the wire guide; however, the tip of the catheter separated prior to making patient contact.There have been no adverse effects to the patient reported.
Additional Manufacturer Narrative
Event summary: as reported, during an unspecified procedure, the tip of a cxi support catheter separated.Another manufacturer's wire was placed via femoral access for a contralateral approach; however, the wire would not advance, and therefore the physician removed the wire and obtained pedal access.The user then removed the complaint device from the package to place it over the wire guide; however, the tip of the catheter separated prior to making patient contact.There have been no adverse effects to the patient reported.Investigation ¿ evaluation: a visual inspection of the returned device was conducted.A document-based investigation was also performed including a review of complaint history, device history record (dhr), the instructions for use, drawing, dimensional verification, and quality control data.The complainant returned one cxi support catheter to cook for investigation.Physical examination of the device revealed the tip on the returned device measured 5mm in length, which is within the 8mm plus or minus 3mm outlined in the specification.The damage to the device tip was unable to be seen under normal examination.The dino cam re-examination revealed the damage to the tip including the exposed fibers.Retraining of the responsible parties was completed on 21mar2022 as a result of this investigation.Cook reviewed the dhr.The dhr for the lot records no nonconformances.The subassembly lot records no relevant nonconformances.A database search for complaints reported related to the complaint lot reveals no additional complaints at this time.Therefore, cook determined that no nonconforming product exists in house or in the field.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.¿ cook concluded that a manufacturing deficiency was the cause of the failure reported.The complaint lot was placed on stop ship and a field action was assessed for the tip failure.No field action was warranted as there is no increase in occurrence.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.
Event or Problem Description
No new patient or event information 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 ; 8128294891
• MDR Report Key: 13017440
• Report Number: 1820334-2021-02692
• Device Sequence Number: 17440298
• Product Code: KRA
• UDI-Device Identifier: 00827002565524
• UDI-Public: (01)00827002565524(17)240430(10)13930321
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 03/31/2022

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: 04/30/2024
• Device Model Number: G56552
• Device Catalogue Number: CXI-2.6-18-150-0
• Device Lot Number: 13930321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2021
• Supplement Date Received by Manufacturer: 03/22/2022
• Initial Report FDA Received Date: 12/16/2021
• Supplement Report FDA Received Date: 03/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2021
• 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