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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NCMDR Recall

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Reference Number:	mdprc 123 03 15 000
Date submitted:	3/30/2015

Manufacturer:	LAAx, Inc.
Device Type:	TIGERPAW System II –7 & 9 connector configurations
Description:	It is indicated for the occlusion of the left atrial appendage
Medical Device Identifier:	- Product Description : TIGERPAW System II –7 & 9 connector configurations - Model Numbers : 1) 7 Connector: C-TP-1507 2) 9 Connector : C-TP-1509 - Lot Numbers : All Lots
Reason of Field Safety Corrective Action:	The Maquet post-marketing vigilance program has identified issues associated with the TIGERPAW System II. There has been an increase in the frequency of field reports involving the following issues which represent a concern: - Incomplete closure of the TIGERPAW System II fastener that may result in tissue tears and/or bleeding.. - Possible tear on the left atrial wall during the use of the device.
Remedy Action:	Please examine your inventory immediately to determine if you have any TIGERPAW System II products. If so, please remove the TIGERPAW System II products, quarantine them and place in a secure location. Your Maquet Representative will contact you shortly to assist with the return of any product. You will be issued a credit by Maquet after the returned product is received.
Athorized Representative/Importer/Distributor:	Al-Faisaliah Medical System, Riyadh, (011) 2114547
Report Source:	NCMDR
Source Ref. Number:	09DED97EC9307
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	LAAx, Inc..pdf

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