Device product
FindrWIRZ Guidewire System Catalog# 40-05 Cardiology: The system is intended for use in the cardiovascular system for introduction and positioning of over the-wire catheters and therapeutic devices during interventional procedures.
Z-0328-2017
Product summary
- Firm
- SentreHeart Inc
- Event
- Event 75395
- Status
- Terminated
- Classification
- Class I
- Quantity
- 132 worldwide distribution (98) of those units in US
- Official record key
device-enforcement:Z-0328-2017
Official wording
Reason: A complaint was received on September 27th, 2016 at a medical center in Germany for delamination and flaking of the PTFE lubricious coating on three FindrWIRZ Guidewire System .025 guidewires removed from their packaging hoops.
Code information: Lot# 01160568 . Lot#02160586, (no products shipped from this lot) Lot# 07160639 -150
Distribution pattern: Worldwide Distribution - US including MO, CA, OR, GA. NH, NY, MI, TX, MD, PA, IL, KS, NE, CT, AZ and Internationally to United Kingdom and Germany
Derived failure modes
-
Unknown
A complaint was received on September 27th, 2016 at a medical center in Germany for delamination and flaking of the PTFE lubricious coating on three FindrWIRZ Guidewire System .025 guidewires removed from their packaging hoops.