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 Code	No Patient Involvement (2645)
Date of Event	04/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Pma / 510(k)# : k122796.This event is currently under investigation.
Event or Problem Description
It was reported that the tip of the cxi support catheter broke off "without any massiv(e) push" before a procedure.There was reportedly no patient involved with the event.
Additional Manufacturer Narrative
A review of the complaint history, dimensional verification, device history record, instructions for use (ifu), quality control, and visual inspection of the returned device was conducted during the investigation.One used and damaged cxi support catheter (finished goods lot 6766174) was returned for evaluation.Device measurements for length, diameter, and distal hole met specification requirements.In the devices returned condition, the distal tip length measurement was out of specification.Review of device history record shows one nonconforming event related to this failure mode.No other reported complaints for this lot number 6766174 were identified.Based on the information provided,and the results of our 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: 6563216
• Report Number: 1820334-2017-01030
• Device Sequence Number: 16163568
• Product Code: KRA
• UDI-Device Identifier: 00827002565517
• UDI-Public: (01)00827002565517(17)190226(10)6766174
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• 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): 06/23/2017

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-2.6-18-90-ANG
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/20/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/12/2017
• Supplement Report FDA Received Date: 06/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1