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

Catalog Number	CXI-2.6-18-150-P-NS-ANG
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 dilation of a chronic total obstruction (cto) of a moderately calcified superficial femoral artery (sfa), a cxi support catheter was found to be broken and separated upon removal from the patient (refer to medwatch 1820334-2018-01530).A second cxi support catheter was used and it, too, was found to be broken and separated upon removal from the patient (refer to this report).During the procedure, another manufacturer's 0.018 inch wire guide was advanced contralaterally from the right femoral artery (fa) past the cto lesion (10cm in length) in the left sfa.The cxi support catheter (refer to medwatch 1820334-2018-01530) was advanced over the wire guide past the target lesion.Upon removal of the complaint device, the physician reportedly felt resistance and applied torque pulling on it forcefully.The cxi support catheter was successfully removed; however, it was observed to be broken and separated at that time.No section of this complaint device remained in the patient's anatomy.A second cxi support catheter (refer to this report) was advanced over the same wire guide and again, resistance was felt upon removal.The physician applied torque and pulled forcefully in order to successfully remove this second complaint device.This cxi support catheter was also successfully removed and found to be broken and separated.This second complaint device and the wire guide were removed as a unit.No section of the device remained in the patient's anatomy.To complete the procedure, a 0.035 inch wire guide was instead advanced past the lesion and balloon dilation of the target lesion was successful.According to the initial reporter, the patient did not require any additional procedures due to this occurrence, and did not experience any adverse effects.
Additional Manufacturer Narrative
A review of the dimensional verification, complaint history, device history record, documentation, drawing, instructions for use (ifu), manufacturing instructions, quality control, specifications, and a visual inspection and functional evaluation of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the device was separated in two sections.The strain relief was pulled down, and no kinks were noted.Measuring from the strain relief, the proximal section measured 83.0 cm in length.A curve was noted at 57.0 cm, and a second curve was noted a distance of 68.0 cm from the strain relief.A sample 0.018" wire guide was used to pass the wire through the full length of the proximal section, and it exited at of the point of separation.A slight resistance was felt when exiting the point of separation, but the wire passed through completely.The distal tip was in good shape with no visible damage.The length from the distal tip to the point of separation was 67.6 cm.Measuring from the distal tip, a curve was noted at 64.8 cm.Upon trying to pass the wire through the distal section, going through the distal tip, the wire stopped at a distance of 41.4 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 the lot was released meeting all finished goods release criteria.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, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the risk assessment, no further action is required.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.Refer to section for investigational findings.

• 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: 7550265
• Report Number: 1820334-2018-01536
• Device Sequence Number: 284473
• Product Code: KRA
• UDI-Device Identifier: 00827002500037
• UDI-Public: (01)00827002500037(17)200609(10)7979428
• Combination Product (Y/N): N
• PMA/510(K) Number: K072724
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2018

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-ANG
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/17/2018
• Supplement Date Received by Manufacturer: 06/28/2018
• Initial Report FDA Received Date: 05/29/2018
• Supplement Report FDA Received Date: 07/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1