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 Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/06/2018
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 an unspecified procedure, the cxi support catheter hub fell off during contralateral advancement of the catheter from the left femoral artery to the severely stenosed lesion.Another cxi support catheter of the same lot was utilized to successfully complete the procedure.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Per information received on 14mar2018, the catheter was advanced from the left femoral artery to the common iliac artery (cia) with severe chronic total occlusion (cto) by retrograde contralateral approach.The physician stated that he may have applied too much torque to the device.Pre-existing conditions: cto in the cia.This report includes information known at this time. a follow-up report will be submitted should additional relevant information become available.
Additional Manufacturer Narrative
Investigation ¿ evaluation.A review of the dimensional verification, complaint history, device history record, documentation, drawing, 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 proximal fitting (hub) was separated from the shaft of the catheter.The strain relief was removed from the hub for further examination, and it was discovered that a small fragment of the catheter material was retained in the hub.The proximal separated end of the catheter was twisted, which prevented the advancement of a test guide wire.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, 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.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.Investigation ¿ evaluation.A review of the dimensional verification, complaint history, device history record, documentation, drawing, 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 proximal fitting (hub) was separated from the shaft of the catheter.The strain relief was removed from the hub for further examination, and it was discovered that a small fragment of the catheter material was retained in the hub.The proximal separated end of the catheter was twisted, which prevented the advancement of a test guide wire.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, 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.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.

• 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: 7330927
• Report Number: 1820334-2018-00668
• Device Sequence Number: 13854371
• Product Code: KRA
• UDI-Device Identifier: 00827002500037
• UDI-Public: (01)00827002500037(17)201103(10)8345933
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K072724
• 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,Followup
• Report Date (Section B): 05/11/2018

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-ANG
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/06/2018
• Supplement Date Received by Manufacturer: 03/14/2018; 05/02/2018
• Initial Report FDA Received Date: 03/12/2018
• Supplement Report FDA Received Date: 03/14/2018; 05/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1