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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Date of Event	03/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Pma/510(k) #: k122796.The device has been requested and not yet received.The event is currently under investigation.
Event or Problem Description
It was reported that during a below the knee (btk) procedure using a cxi support catheter, while introducing the catheter over the wire prior to patient contact, the tip of the cxi catheter broke.The patient was unharmed as this event occurred prior to patient contact.
Additional Manufacturer Narrative
Investigation - evaluation a review of the complaint history, drawings, dimensional verification, device history record, instructions for use (ifu), manufacturing instructions, trends, quality control, and visual inspection of the returned device was conducted during the investigation.One cxi support catheter was returned for evaluation.Kinks were located at 16.7cm, 36.5cm, and 66.8cm from the proximal end and a portion of the distal tip was separated.The attached distal tip measured 4.0mm.The strain relief was attached and secure.The catheter and separated tip were tested with 0.014 inch wire guide and no occlusions were noted.A document-based investigation was also performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows one nonconforming event related to tip damage.It should be noted there were no other reported complaints for this lot number.The device is shipped with an instruction for use (ifu) that describes the intended use, contraindications warnings, and precautions: precautions: this product is intended for use by physicians trained and experienced in small vessel access and interventional procedures.Standard techniques for placement of percutaneous catheters should be employed.Catheter manipulation should only occur under fluoroscopy.This catheter is designed and intended for one time use only.Do not re-sterilize and/or reuse.Based on the information provided and the results of the investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• 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: 6486127
• Report Number: 1820334-2017-00515
• Device Sequence Number: 16465994
• Product Code: KRA
• UDI-Device Identifier: 00827002231627
• UDI-Public: (01)00827002231627(17)191207(10)7498218
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2017

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 Model Number: N/A
• Device Catalogue Number: CXI-2.3-14-135-ANG
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 03/15/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/15/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/12/2017
• Supplement Report FDA Received Date: 06/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1