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

Model Number	N/A
Medical Device Problem Codes	Material Separation (1562); Difficult to Advance (2920)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) # : k122796.The reported device has been received, an evaluation is in progress.
Event or Problem Description
It was reported, the cxi support catheter was noticed to be sticky after being loaded onto the wire.The catheter was removed and the marker band tip of the catheter came off and remained stuck on the wire.This occurred before patient contact.No additional information has been received.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable or unchanged.Investigation - evaluation a review of the complaint history, drawings, dimensional verification, device history record, trends, quality control and visual inspection of the returned device was conducted during the investigation.The device history record was reviewed and two non-conformances were noted.Neither non-conformance was related to the problem reported.The complaint history was reviewed and indicated this is the only complaint of this nature on this specific lot.The visual inspection of the returned device reported the four required marker bands are present and secure.In the devices' current state, the distal tip measured 4mm in length.The alleged separated tip segment was not submitted for evaluation.No assignable cause and/or anomalies associated at manufacturing and packaging processes of the product which could contribute and/or be related with reported incident were identified.A definitive root cause could not be determined.No evidence was found indicating that the device was manufactured outside of cook inc.Specifications.There were no adverse effects to the patient reported due to this occurrence.We will continue to monitor for similar complaints.Per the 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: 6383650
• Report Number: 1820334-2017-00440
• Device Sequence Number: 41716
• Product Code: KRA
• UDI-Device Identifier: 00827002183711
• UDI-Public: (01)00827002183711(17)191206(10)7493575
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2017

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: No Information
• Device Model Number: N/A
• Device Catalogue Number: CXI-2.3-14-90-0
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/06/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/07/2017
• Supplement Report FDA Received Date: 05/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1