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

Model Number G18371

Device Problems Material Puncture/Hole (1504); Appropriate Term/Code Not Available (3191)

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

Event Date 08/17/2021

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfg = device evaluation has begun; however, a conclusion is not yet available.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 below-the-knee treatment procedure via ipsilateral approach from the right femoral artery, another manufacturer's wire would not advance through the hub of a cxi support catheter.The tip of the wire was inserted through the hub, but the wire would not pass.The wire guide tip was altered by the user prior to insertion into the catheter.A wire inserter was not used.Another cxi device of a different size was used to complete the procedure.The anatomy was not tortuous or calcified.There were no adverse effects to the patient.Upon investigation of the returned device, a hole was noted in the shaft of the catheter, and an unknown blue and green substance was flushed from the hub of the device.

Event Description

No additional information has been received since the last report was submitted.

Manufacturer Narrative

Summary of event: as reported, during a below-the-knee treatment procedure via ipsilateral approach from the right femoral artery, another manufacturer's wire would not advance through the hub of a cxi support catheter.The tip of the wire was inserted through the hub, but the wire would not pass.The wire guide tip was altered by the user prior to insertion into the catheter.A wire inserter was not used.Another cxi device of a different size was used to complete the procedure.The anatomy was not tortuous or calcified.There were no adverse effects to the patient.Upon investigation of the returned device, a hole was noted in the shaft of the catheter, and an unknown blue and green substance was flushed from the hub of the device.Investigation evaluation: a review of the complaint history, device history record, documentation, drawing, instructions for use (ifu), and quality control procedures was conducted during the investigation.A visual inspection and functional test of the complaint device was also conducted.One device was received in prior to use condition.A sample 0.014-inch wire guide would not pass through the hub of the device.The strain relief was pulled, and an obstruction was noticed in the hub.The hub was soaked in warm water and the hub was able to be cleared.The obstruction was observed to be a small piece of green and blue material.Once the hub was cleared of debris the wire guide was able to advance through the hub.The wire then encountered resistance at the first marker band from the proximal end of the catheter.There was also an exterior defect noticed approximately 35cm from the strain relief.The device was confirmed to be out of specification.A document-based investigation evaluation was performed.One relevant nonconformance was found; however, affected product was scrapped and not replaced.A database search noted one other complaint on the lot for difficult advancement of a wire guide.Five additional devices from this device lot were pulled and inspected for similar issues.A sample 0.0014¿ wire guide was inserted through the hub and advanced throughout the length of the catheters, until it exited the distal tip.On all five catheters, no exterior damage was noted, the wire guide was able to be inserted into the hub without difficulties, and the wire guide was able to be advanced throughout the catheter without resistance.From the information provided upon review of the customer testimony, dmr, dhr, ifu, and inspection of returned device, cook has concluded that the complaint device was not manufactured to specification.The inspection of the five additional unused catheters leads cook to conclude that no additional nonconforming product from this lot exists in-house or in the field.The product ifu states ¿upon removal from package, inspect the product to ensure no damage has occurred.¿ cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the information provided and the results of the investigation, cook has concluded that a quality control deficiency contributed to this incident.The appropriate personnel were retrained on 25oct2021.The risk analysis for this failure mode was reviewed and no additional escalation was required.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.

• 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: 12646785
• MDR Text Key: 277496294
• Report Number: 1820334-2021-02342
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00827002183711
• UDI-Public: (01)00827002183711(17)240503(10)13935224
• Combination Product (y/n): N
• PMA/PMN Number: K122796
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/24/2022

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: 05/03/2024
• Device Model Number: G18371
• Device Catalogue Number: CXI-2.3-14-90-0
• Device Lot Number: 13935224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/01/2021
• Initial Date FDA Received: 10/18/2021
• Supplement Dates Manufacturer Received: 01/07/2022
• Supplement Dates FDA Received: 01/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2021
• 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: GLADIUS AHAHI INTECC 0.014IN HYDROPHILIC ANGLE; MEDIKIT 3FR 45CM PARENT PLUS 30