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

Model Number G18371

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/20/2019

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) number = k122796.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 angiography and possible stenting of the tibial arteries, foreign matter was found upon flushing a cxi support catheter.The device was opened and flushed and then threaded over another manufacturer's 0.014 inch, 300 centimeter, hydrophilic-coated, stainless steel wire guide with a nitinol tip; however, the catheter would not track over the wire.The catheter was removed from the wire and flushed again, at which time "some green colored matter" came out of the catheter.Per the reporter, there was no apparent damage to the wire guide.The complaint device was discarded and another device of the same type was used to complete the procedure, using the original wire guide.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

Initial report: as reported, during angiography and possible stenting of the tibial arteries, foreign matter was found upon flushing a cxi support catheter.The device was opened and flushed and then threaded over another manufacturer's 0.014 inch, 300 centimeter, hydrophilic-coated, stainless steel wire guide with a nitinol tip; however, the catheter would not track over the wire.The catheter was removed from the wire and flushed again, at which time "some green colored matter" came out of the catheter.Per the reporter, there was no apparent damage to the wire guide.The complaint device was discarded and another device of the same type was used to complete the procedure, using the original wire guide.Investigation - evaluation.Reviews of the complaint history, device history record, documentation, instructions for use (ifu), manufacturer¿s instructions, quality control procedures, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned package confirms that one prior to use cxi support catheter was returned for investigation.The device was not damaged.The device was flushed with water, and no green matter was noted exiting the catheter.No issues were identified with the device during the analysis.Additionally, a document-based investigation evaluation was performed.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should also be noted there were no other reported complaints for this lot number.Furthermore, reviews of the manufacturer¿s instructions and quality control procedures were conducted, and no gaps were discovered.Given this information, there is no evidence to suggest that non-conforming product from this lot exists in house or in the field.An ifu is provided with this device, which states ¿upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the information provided and the examination of the returned product, investigation has concluded that a cause for the failure could not be determined at this time.It is possible that the reported green matter may have been the coating on the other manufacturer¿s wire guide.The complaint rate aligns with current risk documentation, and no further escalation is required at this time.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.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 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: 9139515
• MDR Text Key: 176588065
• Report Number: 1820334-2019-02464
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00827002183711
• UDI-Public: (01)00827002183711(17)220328(10)9625560
• 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: 04/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2022
• Device Model Number: G18371
• Device Catalogue Number: CXI-2.3-14-90-0
• Device Lot Number: 9625560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2019
• Date Manufacturer Received: 04/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ABBOTT WIRE GUIDE