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

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

Device Problems Contamination (1120); Contamination /Decontamination Problem (2895)

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

Event Date 08/09/2023

Event Type  malfunction  

Event Description

As originally reported, during a procedure to open an arterial occlusion in the left leg, a wire was difficult to insert/advance through a cxi support catheter after the catheter was inserted into the patient, despite multiple attempts to pass the wire through the catheter.The device was replaced with a new catheter, and the procedure was continued.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.Upon return and evaluation of the device, foreign matter was noted, coming out through the distal catheter tip.

Manufacturer Narrative

E1: customer name and address: (b)(6).Phone: (b)(6).H3: device evaluated by mfg: other (81)- 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.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.

Manufacturer Narrative

Corrected information: h6 (annex a) summary of event: as originally reported, during a procedure to open an arterial occlusion in the left leg, a wire was difficult to insert/advance through a cxi support catheter after the catheter was inserted into the patient, despite multiple attempts to pass the wire through the catheter.The device was replaced with a new catheter, and the procedure was continued.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.Upon return and evaluation of the device, foreign matter was noted, coming out through the distal catheter tip.Investigation evaluation: reviews of the complaint history, device history record (dhr), manufacturing instructions, and quality control procedures were conducted during the investigation.A visual inspection of the complaint device was also conducted.The complaint device was returned to cook for investigation.Testing confirmed the presence of both biological matter and foreign material in the device.The floppy end of a sample 0.018-inch wire guide would not pass through the catheter hub before or after placing the catheter in an ultrasound bath to remove biological matter from the hub.The stiffened end of the wire was inserted into the hub, meeting heavy resistance; however, the wire would not pass through the catheter body.Clear, plastic-like foreign material was noted, coming out of the distal catheter tip.A document-based investigation evaluation was performed.A review of the device history record found no relevant non-conformances on the lot.A review of complaint history found no additional relevant complaints for this lot number.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The information provided upon review of the dmr, dhr, and investigation of the returned device suggests that there is evidence the device was manufactured to specification.There is no evidence of non-conforming devices in-house or in the field.Based on the information provided and the results of the investigation, cook has concluded that a component failure, unrelated to the design or manufacturing of the complaint device, contributed to this event.Although foreign material was noted, due to the amount of biological matter and catheter damage sustained from the procedure, the origin of the foreign material could not be determined.Discussions with qualified manufacturing personnel determined that the issue was not caused by a manufacturing deficiency.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: 17777152
• MDR Text Key: 323767889
• Report Number: 1820334-2023-01261
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• PMA/PMN Number: K160884
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/28/2024

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: 15142929
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/29/2023
• Initial Date FDA Received: 09/19/2023
• Supplement Dates Manufacturer Received: 02/19/2024
• Supplement Dates FDA Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/03/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 52 KG