Device product
OSCOR ADELANTE BREEZEWAY 8F C120¿ S79CM D84CM Catalog # AB081047 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
Z-0797-2017
Product summary
- Firm
- Oscor, Inc.
- Event
- Event 75785
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11
- Official record key
device-enforcement:Z-0797-2017
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: C1-09372 Exp. November 5, 2017, C1-10142 Exp. April 22, 2018 and OR-04728 Exp. October 21, 2018
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.