Device product
TIGERPAW System II, Part number C-TP-1507 (7 connector) The TigerPaw System II is an implantable occlusion Fastener to be placed on the Ostium of the Left Atrial Appendage (LAA).
Z-1461-2015
Product summary
- Firm
- Laax, Inc.
- Event
- Event 70853
- Status
- Terminated
- Classification
- Class I
- Quantity
- ~ 4,154 total units in US - both model numbers
- Official record key
device-enforcement:Z-1461-2015
Official wording
Reason: Increase of field reports involving issues with the TIGERPAW System II resulting in possible tissue tearing on left atrial wall and bleeding during use of the device, which may or may not be caused by incomplete closure of the TigerPaw System II fastener.
Code information: Part number C-TP-1507 (7 connector) All serial numbers/lots
Distribution pattern: Worldwide Distribution: US (nationwide) and countries of:Australia, Bahrain, Belgium, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Ireland, Israel, Italy Netherland, Norway, Poland, Qatar, Slovenia, Spain, Saudi Arabia, Sweden, Switzerland, Turkey and United Kingdom.
Derived failure modes
-
Unknown
Increase of field reports involving issues with the TIGERPAW System II resulting in possible tissue tearing on left atrial wall and bleeding during use of the device, which may or may not be caused by incomplete closure of the TigerPaw System II fastener.