OUTBACK
Received Dec 15, 2025
Report 9616099-2025-02008 · MDR key 23802722
Device
Generic name
Catheter For Crossing Total Occlusions
Manufacturer
Cordis Us Corp.Model number
NACatalog number
OTB42120
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Vascular Dissection
- Vascular Dissection
Narrative
Description of Event or Problem
AS REPORTED IN THE OUTBACK ELITE RE-ENTRY CATHETER FEEDBACK SURVEY, RESPONDENT 24 EXPERIENCED A VESSEL DISSECTION AFTER THE USE OF AN UNKNOWN OUTBACK RE-ENTRY CATHETER, WHICH REQUIRED BAILOUT STENTING. THERE WERE NO ADDITIONAL REPORTED INJURIES. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.
Additional Manufacturer Narrative
AS REPORTED IN THE OUTBACK ELITE RE-ENTRY CATHETER FEEDBACK SURVEY, RESPONDENT 24 EXPERIENCED A VESSEL DISSECTION AFTER THE USE OF AN UNKNOWN OUTBACK RE-ENTRY CATHETER, WHICH REQUIRED BAILOUT STENTING. THERE WERE NO OTHER REPORTED INJURIES. THE DEVICE WAS NOT RETURNED FOR ANALYSIS, AND A PRODUCT HISTORY RECORD (PHR) REVIEW COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER FOR THIS PRODUCT IS UNKNOWN. IT CANNOT BE FOUND WHETHER THE REPORTED ¿ARTERY ¿ DISSECTION¿ WAS RELATED TO THE USE OF THIS DEVICE BECAUSE NO IMAGES WERE AVAILABLE FOR REVIEW AND NO PRODUCT EVALUATION WAS COMPLETED TO IDENTIFY A MALFUNCTION THAT MAY HAVE CONTRIBUTED TO THE EVENT. AS A RESULT, THE ROOT CAUSE OF THE DISSECTION CANNOT BE ESTABLISHED, AND PROCEDURAL FACTORS CANNOT BE EXCLUDED. VESSEL DISSECTION IS A KNOWN COMPLICATION ASSOCIATED WITH THIS TYPE OF DEVICE AND IS DESCRIBED IN THE PRODUCT LABELING. THERE IS NO EVIDENCE INDICATING A DESIGN OR MANUFACTURING ISSUE, AND NO ADDITIONAL ACTIONS ARE WARRANTED AT THIS TIME.