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

Model Number G23162

Device Problem Material Separation (1562)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/30/2020

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, prior to use during a below-the-knee procedure for peripheral artery disease, the tip of a cxi support catheter was found to have separated from the device.This observation was made prior to patient contact.Another device of the same type was opened and used to complete the procedure successfully.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, unchanged, or unavailable.Description of event: as reported, prior to use during a below-the-knee procedure for peripheral artery disease, the tip of a cxi support catheter was found to have separated from the device.This observation was made prior to patient contact.Another device of the same type was opened and used to complete the procedure successfully.Investigation ¿ evaluation a document based investigation was performed including a review of complaint history, device history record, documentation, the instructions for use, manufacturing instructions, and quality control data.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 made out of specification.A search of cook¿s inventory determined that all products from the reported lot were already out of cook¿s control and thus a representative device from the lot could not be examined.A review of the device history record found no non-conformances related to the reported failure mode.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.A review of complaint history records shows no other complaints associated with the complaint device lot.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: intended use: ¿the cxi support catheter is intended for use in small vessel or super selective anatomy for diagnostic and interventional procedures, including peripheral use.¿ precautions: ¿ 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.¿ instructions for use: ¿2.Activate the hydrophilic coating by wetting the catheter with heparinized saline solution or sterile water.To ensure hydrophilic activation, wet the entire surface of the catheter.Note: the surface of the catheter may become dry if not used immediately after activation.Additional wetting with heparinized saline solution or sterile water will reactivate the hydrophilic coating.3.Under fluoroscopic guidance, introduce the catheter into the vascular system using standard techniques.¿ how supplied: ¿upon removal from package, inspect the product to ensure no damage has occurred.¿ 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.With current information, it is likely that the device was damaged during either shipping or during unpackaging of the device at the facility.Per the quality engineering risk assessment, no further action is warranted.Cook 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 new patient or event information to report.

• 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: 11207093
• MDR Text Key: 229641416
• Report Number: 1820334-2021-00136
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00827002231627
• UDI-Public: (01)00827002231627(17)230820(10)13379813
• Combination Product (y/n): N
• PMA/PMN Number: K122796
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 05/03/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 08/20/2023
• Device Model Number: G23162
• Device Catalogue Number: CXI-2.3-14-135-ANG
• Device Lot Number: 13379813
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/11/2021
• Initial Date FDA Received: 01/21/2021
• Supplement Dates Manufacturer Received: 04/07/2021
• Supplement Dates FDA Received: 05/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1