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

Model Number	G50001
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) number = k160884.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.
Event or Problem Description
As originally reported, during an unknown procedure to treat peripheral arterial occlusive disease, involving a patient of unknown age and gender, two (other manufacturer's) wire guides were not successfully introduced into a cxi support catheter.The device was reportedly flushed prior to wire insertion.Upon analysis of the returned complaint device on (b)(6) 2019, investigators encountered resistance upon attempted wire guide insertion, and observed green material being ejected from the catheter along with the wire.What appeared to be part of the inner lumen of the catheter was also protruding from the distal tip of the device.There has been no report that any part of the device remained in the patient's body, that the patient required any additional procedures, or that the patient experienced any adverse effects due to this event.
Additional Manufacturer Narrative
Original description of event: as originally reported, during an unknown procedure to treat peripheral arterial occlusive disease, involving a patient of unknown age and gender, two (other manufacturer's) wire guides were not successfully introduced into a cxi support catheter.The device was reportedly flushed prior to wire insertion.Upon analysis of the returned complaint device on 07jun2019, investigators encountered resistance upon attempted wire guide insertion, and observed green material being ejected from the catheter along with the wire.What appeared to be part of the inner lumen of the catheter was also protruding from the distal tip of the device.There has been no report that any part of the device remained in the patient's body, that the patient required any additional procedures, or that the patient experienced any adverse effects due to this event.Investigation ¿ evaluation: a review of the complaint history, device history record, instructions for use, quality control, and manufacturing instructions, as well as a visual inspection and functional test of the complaint device was conducted during the investigation.The visual inspection of the complaint device confirmed that one used cxi-2.6-18-150-p-ns-0 catheter was returned.A.018" wire was inserted, and resistance was met.When wire was removed there was an unknown (possibly green) substance on the wire.There was also a clear unknown substance on the tip of the catheter that was able to be removed.The wire could be inserted into the endhole (distal tip) but rested in the opening and would not advance.The wire was able to be inserted through the proximal hub to the tip of catheter but would not exit the tip.The unknown material was evaluated under amplified camera imaging and was found to be a grey color and had a shaved appearance.Based on the evaluation, the shaved unknown material was likely from a wire guide scraping while the attempt was made to pass the wire guide through the hub.Also, of note, the sample wire guide used had a floppy proximal end, which could not be advanced into the hub.The stiff distal end could be inserted into the hub.A document-based investigation evaluation was performed.One nonconformance was noted; however, the device was scrapped and not replaced.Two other complaint were found for this lot number; however, they were not related to this failure mode.Review of manufacturing and quality control instructions revealed that there is no evidence to suggest a gap in the manufacturing process.The ifu for this device states: ¿under fluoroscopic guidance, introduce the catheter into the vascular system using standard techniques¿ and ¿upon removal from package, inspect the product to ensure no damage has occurred¿.Based on inspection of the complaint device and results of the investigation, investigation has concluded that a root cause for this event cannot be determined; although, it is possible that the event is the result of user handling during insertion of the initial wire guide into the catheter.Per the quality engineering risk assessment, no further action is required.Cook will continue to monitor for similar complaints.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 or Problem 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
• Common Device Name: KRA CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8684219
• Report Number: 1820334-2019-01325
• Device Sequence Number: 2260237
• Product Code: KRA
• UDI-Device Identifier: 00827002500013
• UDI-Public: (01)00827002500013(17)210803(10)9067069
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/03/2021
• Device Model Number: G50001
• Device Catalogue Number: CXI-2.6-18-150-P-NS-0
• Device Lot Number: 9067069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 03/30/2020
• Initial Report FDA Received Date: 06/10/2019
• Supplement Report FDA Received Date: 04/06/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2 ASAHI WIRES- 0.014 INCH; 2 ASAHI WIRES- 0.014 INCH