Device product
OSCOR ADELANTE BREEZEWAY 10F C120¿ S61CM D66CM Catalog # AB101075 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
Z-0802-2017
Product summary
- Firm
- Oscor, Inc.
- Event
- Event 75785
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8
- Official record key
device-enforcement:Z-0802-2017
Official wording
Reason: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Code information: Lot #'s: C1-12145 Exp. November 29, 2018, C1-08466 Exp. December 19, 2016 and OR-04823 Exp. June 16, 2019
Distribution pattern: Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico. Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM
Derived failure modes
-
Unknown
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.