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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 148 12 12 000
Date submitted: 12/24/2012
Manufacturer:Covidien
Device Type:Pipeline Embolization Device (PED)
Description:Pipeline Embolization Device (PED)
Medical Device Identifier:all codes
Reason of Field Safety Corrective Action:The PED might not readily disengage from the capture coil, and the PED might not completely open and appose the vessel wall.
Remedy Action: In order to minimize the risk of possible delivery related complications, Covidien recommends adherence to the following guideline identified in the product IFU: “Caution: If excessive resistance is noted during the use of the Pipeline Embolization Device or microcatheter at any time during the procedures, discontinue the delivery of the Pipeline Embolization Device against resistance may result in device damage or patient injury.” The treating physician should evaluate the utility and associated risk of repeat deployment with a replacement device. (See attached).
Athorized Representative/Importer/Distributor:Al-Faisaliah Medical System, Riyadh, 0)1 ( 2119948
Report Source:NCMDR
Source Ref. Number:0DBE680D1C15C
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Covidien.pdf