FDA Adverse Event Injury Summary report: N

CORDIS

MDR report key: 2982714 · Received February 22, 2013

Report

Report Number
MW5029158
Event Type
Injury
Date Received
February 22, 2013
Date of Event
February 13, 2013
Report Date
February 22, 2013
Manufacturer
CORDIS
Product Code
DTK
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
TX, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

IVC FILTER WAS UNABLE TO BE DEPLOYED DURING PROCEDURE. UPON INSPECTION, IT WAS FOUND THAT THE FILTER STRUT WAS PROTRUDING THROUGH THE SHEATH.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
77354 CORDIS OPTEASE FILTER DTK CORDIS

Patients

Seq Age Sex Outcome Treatment
1 63 YR Required Intervention