Device product
OSCOR ADELANTE BREEZEWAY 8F STRAIGHT S61CM D66CM Catalog # AB081210 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
Z-0798-2017
Product summary
- Firm
- Oscor, Inc.
- Event
- Event 75785
- Status
- Terminated
- Classification
- Class II
- Quantity
- 26
- Official record key
device-enforcement:Z-0798-2017
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: OR-04691 Exp. July 16, 2018, C1-11728 Exp. October 4, 2018, C1-09375 Exp. November 5, 2017 and C1-09375 Exp. November 5, 2017
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.