Device product
ThruPort Knot Pusher. This device is sold individually (Model KP1) and as part of the ThruPort Valve Placement Pack (Model VPP). packaged sterile and non-pyrogenic in a sealed, peel-type pouch. The Knot Pusher is a sterile disposable plastic rod used to advance extracorporeal suture knots during minimally invasive cardiac surgery.
Z-2780-2015
Product summary
- Event
- Event 72046
- Status
- Terminated
- Classification
- Class II
- Quantity
- 759 units
- Official record key
device-enforcement:Z-2780-2015
Official wording
Reason: The configuration of the slot at the tip of the knot pusher may inhibit intended ease of use. Fraying or splitting of the suture could occur, which could compromise the integrity of the suture knot.
Code information: Model: KP1 - Lot No: 59964698, 59967596, 59984375, 60016312, 60045801, 60045802, 60059982, 60066591, 60089865 Model VPP Lot No: 60022521, 60022522, 60064112
Distribution pattern: Worldwide Distribution - US (nationwide) Distribution and to the countries of : Canada, Japan and Europe.
Derived failure modes
-
Unknown
The configuration of the slot at the tip of the knot pusher may inhibit intended ease of use. Fraying or splitting of the suture could occur, which could compromise the integrity of the suture knot.