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

Model Number G23160

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/12/2021

Event Type  malfunction  

Manufacturer Narrative

This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

As reported, during a procedure involving peripheral revascularization of the tibial arteries via contralateral groin access, an unknown string-like substance was pulled from a cxi support catheter.The anatomy was tortuous and calcified.The device was advanced over another manufacturer's 0.014" wire into the distal tibial plateau.The wire was removed, and the user attempted to flush the device with contrast using a syringe, but the catheter would not flush through the hub.The user then attempted to reintroduce the 0.014" wire, but it would not exit through the catheter.The wire and catheter were removed, and a string was pulled from the inside of the catheter.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

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Correction: d9 event summary as reported, during a procedure involving peripheral revascularization of the tibial arteries via contralateral groin access, an unknown string-like substance was pulled from a cxi support catheter.The anatomy was tortuous and calcified.The device was advanced over another manufacturer's 0.014" wire into the distal tibial plateau.The wire was removed, and the user attempted to flush the device with contrast using a syringe, but the catheter would not flush through the hub.The user then attempted to reintroduce the 0.014" wire, but it would not exit through the catheter.The wire and catheter were removed, and a string was pulled from the inside of the catheter.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.Investigation - evaluation reviews of the complaint history, device history record, instructions for use, drawing, and quality control procedures of the device were conducted during the investigation.No device was returned for investigation.A photo of the device was provided by the user which shows a fiber-like material inside the plastic package alongside the spiral holder.A document-based investigation evaluation was performed.No related non-conformances were recorded, and there have been no other reported complaints for this lot number.There is no evidence of additional nonconforming devices from the complaint lot in house or in the field.The device is provided instructions for use which state, ¿store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the available information, cook has concluded that a manufacturing and quality control deficiency contributed to the observed foreign matter.Cook will continue monitoring of similar complaints and has notified the appropriate personnel of this event.Per the quality engineering risk assessment, no further action is required.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
• 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: 12365432
• MDR Text Key: 268064253
• Report Number: 1820334-2021-02049
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00827002231603
• UDI-Public: (01)00827002231603(17)240126(10)13717259
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122796
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/07/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 01/26/2024
• Device Model Number: G23160
• Device Catalogue Number: CXI-2.3-14-135-0
• Device Lot Number: 13717259
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/12/2021
• Initial Date FDA Received: 08/25/2021
• Supplement Dates Manufacturer Received: 01/03/2022
• Supplement Dates FDA Received: 01/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BOSTON ROTABLADER ATHERECTOMY DEVICE; CHOICE 014 PT EXTRA SUPPORT WIRE; COOK 6 FR ANSEL 45CM SHEATH; ROTA WIRE; BOSTON ROTABLADER ATHERECTOMY DEVICE; CHOICE 014 PT EXTRA SUPPORT WIRE; COOK 6 FR ANSEL 45CM SHEATH; ROTA WIRE