MAUDE Adverse Event Report: COOK INC Cook Spectrum; FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number	G50819
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/14/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device name- cook spectrum minocycline/rifampin impregnated double lumen central venous catheter tray.This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
Event or Problem Description
The customer reported that while placing a central line in a patient, they encountered resistance while advancing the guidewire through the catheter.They weren¿t sure if the wire was being obstructed in the catheter or the patient, but when they tried to remove the wire, it caught again and began stretching.They then removed the guidewire and catheter together, and the procedure was completed with a different device.The reporter also checked the complaint device after the procedure and alleged that lumen of the catheter was abnormal and narrow, causing resistance for the guidewire.No part of the complaint device was left in the patient, and there were no injuries or additional procedures.

• Brand Name: Cook Spectrum
• Common Device Name: FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6890313
• Report Number: 1820334-2017-03185
• Device Sequence Number: 827421
• Product Code: FOZ
• UDI-Device Identifier: 00827002508194
• UDI-Public: (01)00827002508194(17)180731(10)6431617
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2017

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: G50819
• Device Catalogue Number: C-UDLMY-801J-ABRM-HC-FST-A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2017
• Initial Report FDA Received Date: 09/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1