SFDA National Center for Medical Devices Reporting

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Medical Devices Sector قطاع الأجهزة الطبية	NCMDR National Center for Medical Devices Reporting المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
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Reference Number:	mdprc 124 11 15 000
Date submitted:	11/30/2015

Manufacturer:	Boston Scientific Cardiac Rhythm Management Group
Device Type:	IntellaTip MiFi™ XP Asymmetric (N4) Curve Temperature Ablation Catheters
Description:	Catheters
Medical Device Identifier:	Product Description: IntellaTip MiFi XP Asymmetric (N4) Curve Material Number (UPN): M004EPM4500N40 Product Description: IntellaTip MiFi XP Asymmetric (N4) Curve Material Number (UPN): M004EPM4790N40 Product Description: IntellaTip MiFi XP Asymmetric (N4) Curve Material Number (UPN): M004PM4500N40 Product Description: IntellaTip MiFi XP Asymmetric (N4) Curve Material Number (UPN): M004PM4790N40 LOT: Please refer to attachment
Reason of Field Safety Corrective Action:	Boston Scientific has received reports of bent distal tips, and in four cases, this situation resulted in exposed internal wires in the asymmetric curve models (known as N4) of IntellaTip MiFi XP.
Remedy Action:	If you identify any product from the affected lots within your inventory, please segregate the affected product immediately and return it to Boston Scientific in accordance with the enclosed removal instructions. You will receive credit for all affected product that is returned to Boston Scientific.
Athorized Representative/Importer/Distributor:	FAROUK, MAAMOUN TAMER & COMPANY
Report Source:	NCMDR
Source Ref. Number:	B098BC34992D1
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Boston Scientific.pdf

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