OUTBACK
Received May 5, 2026
Report 9616099-2026-00658 · MDR key 25089554
Device
Generic name
Catheter For Crossing Total Occlusions
Manufacturer
Cordis Us Corp.Catalog number
OTB59120A
Lot number
18410332
Product problems
- Fracture
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
E1 PH#: (B)(6). ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
Description of Event or Problem
AS REPORTED, THE DOCTOR INSERTED THE OUTBACK ELITE THROUGH A NON-CORDIS 6F 40CM SHEATH, OVER A .035 GUIDEWIRE, POSITIONING IT FOR NEEDLE FIRING. HOWEVER, IMMEDIATELY AFTER FIRING, IT WAS OBSERVED THAT THE RADIOPAQUE TIP OF THE OUTBACK DETACHED INSIDE THE PATIENT, MAKING IT IMPOSSIBLE TO REMOVE. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, THE INFORMATION WAS NOT OBTAINED AFTER MULTIPLE ATTEMPTS. THE DEVICE WILL BE RETURNED FOR EVALUATION.