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

Catalog Number CXI-2.6-18-150-P-NS-0

Device Problem Separation Problem (4043)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/11/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant products: additional devices used includes a micropuncture to gain access and likely other catheters which were unspecified.Occupation: lab manager.Pma/510(k): k160884.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported that the hub of a cxi support catheter separated from the shaft of a catheter during a procedure.The access site for the wire was the femoral artery, but the target location remains unknown.While trying to cross an occlusion, there was a "heavy amount of torqueing and twisting".The shaft of the catheter then separated from the hub and the physician decided to remove the device.Another device was used to complete the procedure, and it was reported that this device also separated and had to be removed from the patient.The separation of the second device is reported in another mdr with patient ref number: (b)(6).A micropuncture was used to gain access, and other catheters were also used during the procedure.It is unknown if the patient's anatomy was tortuous or calcified.It was reported there were no adverse effects to the patient.

Manufacturer Narrative

Summary of event: it was reported that the hub of a cxi support catheter separated from the shaft of a catheter during a procedure.The access site for the wire was the femoral artery, but the target location remains unknown.While trying to cross an occlusion, there was a "heavy amount of torqueing and twisting".The shaft of the catheter then separated from the hub and the physician decided to remove the device.Another device was used to complete the procedure, and it was reported that this device also separated and had to be removed from the patient.The separation of the second device is reported in another mdr with patient ref number: (b)(4).A micropuncture was used to gain access, and other catheters were also used during the procedure.It is unknown if the patient's anatomy was tortuous or calcified.It was reported there were no adverse effects to the patient.Investigation evaluation: a review of the documentation, instructions for use (ifu), manufacturing instructions, and quality control was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.A document-based investigation evaluation was performed.The lot number of the device is not known; accordingly, a review of the device history record could not be conducted.The product ifu states: ¿the cxi support catheter is intended for use in small vessel or superselective anatomy for diagnostic and interventional procedures, including peripheral use.¿ ¿this product is intended for use by physicians trained and experienced in small vessel access and interventional procedures.Standard techniques for placement of percutaneous catheters should be employed.¿ ¿catheter manipulation should only occur under fluoroscopy.¿ ¿the catheter should not be advanced into a vessel having a reference vessel diameter smaller than the catheter outer diameter.¿ ¿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.¿ ¿upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the findings of the investigation, there is no evidence to suggest that the device was manufactured out of specification.No gaps have been found in the manufacturing and quality control process.Investigation has concluded that the cause for this event could not be determined; although, possible reasons for the failure could be related to the patient's anatomy, handling of the device during the procedure, and/or the nature of the procedure itself.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.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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: 9823760
• MDR Text Key: 183352589
• Report Number: 1820334-2020-00598
• 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: 04/15/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: CXI-2.6-18-150-P-NS-0
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/27/2020
• Initial Date FDA Received: 03/12/2020
• Supplement Dates Manufacturer Received: 04/02/2020
• Supplement Dates FDA Received: 04/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1