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

Catalog Number	CXI-4.0-35-135-P-NS-0
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/16/2018
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, the cxi support catheter was being utilized for a procedure to open an occlusion in the patient's femoral artery via ipsalateral approach.While advancing the cxi support catheter along the wire guide, it became lodged and would not advance.Upon removal, the middle section was found to be compressed.Because only one cxi support catheter had been prepared, the procedure could not be completed.It is not known when it will be rescheduled.During follow up with the complainant, it was reported the complaint device had been flushed prior to placement in the vessel.The device flushed normally; the compressed section was not observed.The patient's anatomy presented with tortuosity and calcification with an artery occlusion of 0.5 centimeters.The patient outcome has been reported as "normal".A section of the device did not remain inside the patient¿s body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation ¿ evaluation.A review of the device history record, complaint history, dimensional verification, documentation, drawing, instructions for use, quality control, manufacturing instructions, a visual inspection and functional test of the returned device were conducted during the investigation.The device failure analysis revealed damage to the shaft in the form of flattening and kinks.Two sections of the device were fattened, the first flattened section was 74.5 cm from the proximal hub to 76 cm, the second was 79 cm from the proximal hub to 80cm.The two kinks were noted at 84 cm and 85.5 cm.During the wire guide test, the wire passed the proximal hub to the first flattened section but would not advance further.While advancing from the distal tip, the wire guide went passed the two kinks, but would not advance beyond the second flattened section.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 patient's condition.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: 7678190
• Report Number: 1820334-2018-02020
• Device Sequence Number: 10924027
• Product Code: KRA
• UDI-Device Identifier: 00827002525429
• UDI-Public: (01)00827002525429(17)190118(10)6529572
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K072724
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other Caregivers
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/18/2019
• Device Catalogue Number: CXI-4.0-35-135-P-NS-0
• Device Lot Number: 6529572
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/20/2018
• Supplement Date Received by Manufacturer: 10/01/2018
• Initial Report FDA Received Date: 07/11/2018
• Supplement Report FDA Received Date: 10/08/2018
• 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: UNSPECIFIED WIRE GUIDE; UNSPECIFIED WIRE GUIDE
• Outcome Attributed to Adverse Event: Other
• Patient Age: 78 YR