Device product
OSCOR BREEZEWAY 10F S60.8CM D65.6CM FIRM TIP Catalog # AB1061FT Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
Z-0810-2017
Product summary
- Firm
- Oscor, Inc.
- Event
- Event 75785
- Status
- Terminated
- Classification
- Class II
- Quantity
- 255
- Official record key
device-enforcement:Z-0810-2017
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: C1-08260 Exp. October 6, 2016 and C1-08283 October 14, 2016
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.