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

Catalog Number CXI-2.6-18-150-0

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/20/2019

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) number: k122796.A follow-up report will be submitted should additional relevant information become available.

Event Description

As reported, during an unknown procedure via pedal access, involving a patient of unknown age and gender, a cxi support catheter split in half.An unknown pedal access kit was used to access the tibial vessel.Upon advancement to the target site, through "very calcified" anatomy, the middle of the device split.The device was over a wire and was removed without further intervention.The procedure was completed with another device and the patient's outcome was reported as good.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Investigation evaluation: reviews of the drawing, instructions for use (ifu), manufacturing instructions, and quality control were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.The lot number of the device is not known; accordingly, a review of the device history record could not be conducted.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: "the catheter should not be advanced through an area of resistance unless the source of resistance is identified by fluoroscopy and appropriate steps are taken to reduce or remove the obstruction." a review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.The device, nor any representative devices, images, lot number, or additional information was provided for investigation.Therefore, a device failure analysis, review of the device history record, and search for related complaints could not be completed.Also, a search for other complaints in the same lot with similar occurrences could not be utilized for this complaint event.The complaint has been confirmed based on the customer's testimony.Also, based on the customer testimony, a possible reason that the failure took place could be due to patient anatomy (ie tip getting lodged in calcified anatomy) and user handling during the procedure.Per the quality engineering risk assessment, no further action is warranted.Cook medical has notified the appropriate personnel and 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 Description

No additional patient or event information has been received since the previous report was submitted on 06sep2019.

• Brand Name: CXI SUPPORT CATHETER
• Type of Device: KRA CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8969313
• MDR Text Key: 156758022
• Report Number: 1820334-2019-02240
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CXI-2.6-18-150-0
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1