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

Catalog Number	CXI-2.6-18-150-P-NS-0
Medical Device Problem Code	Physical Property Issue (3008)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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
It was reported, that during an unspecified procedure, the cxi support catheter became stuck at the hub of the catheter and could not be advanced further.Another manufacturer's wire guide was advanced into the complaint device from the proximal end when it became lodged in the hub.Another manufacturer's catheter was used instead and the procedure was successfully completed without any patient adverse effects.Upon receipt of the complaint device by the manufacturer, it was noted the catheter had skive damage (thin layers cut off) which ran almost the full length of the device leaving the braided wire of the shaft exposed approximately 28.1cm from the distal tip.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the dimensional verification, complaint history, device history record, instructions for use (ifu), quality control, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed the presence of what appeared to be skive damage.This damage was noticed on the full length of the outside of the shaft of the device.Measuring from the strain relief, a kink was visible at a distance of 146.2 cm.There was tip damaged and out of round, and it looked jagged (but not sharp).A sample 0.018 wire guide was used to check for any blockages in the cxi; however, the wire guide could not be inserted into the hub.An attempt was made to insert the wire guide into the distal tip, and the wire stopped at a distance of 47.5 cm from the distal tip of the device.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, the examination of the returned product, and the results of our investigation, the root cause was determined to be related to the device manufacturing process.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.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 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: 7558532
• Report Number: 1820334-2018-01636
• Device Sequence Number: 1899255
• Product Code: KRA
• UDI-Device Identifier: 00827002500013
• UDI-Public: (01)00827002500013(17)201116(10)8379378
• Combination Product (Y/N): N
• 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): 09/11/2018

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 Catalogue Number: CXI-2.6-18-150-P-NS-0
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/18/2018
• Supplement Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 05/31/2018
• Supplement Report FDA Received Date: 09/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COMMAND WIRE GUIDE 0.014INCH/ABBOTT