2.8FR PROGREAT MICROCATHETER
Received Oct 28, 2025
Report MW5178058 · MDR key 23402698
Device
Generic name
Catheter, Intravascular, Diagnostic
Manufacturer
Terumo / Ashitaka Factory Of Terumo Corp.Model number
2.8FR PROGREAT MICROCATHETERProduct problems
- Failure to Advance
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT COILS WOULD NOT ADVANCE. THE PHYSICIAN WAS COILING A GDA THROUGH A NON-(B)(6) MICROCATHETER. THEY PLACED A FEW EMBOLD FIBERED COILS FIRST, THEN 2 RUBY STANDARD COILS, THEN ATTEMPTED TO PLACE THE EMBOLD 60CM PACKING COIL AND TECHNOLOGIST STATED THAT THE COIL WOULD NOT ADVANCE MORE THAN HALFWAY OUT OF THE COIL SHEATH. THEY TRIED A FEW TIMES AND THEN DECIDED TO DISCARD IT. THEY GRABBED ANOTHER EMBOLD 60CM PACKING COIL AND HAD NO ISSUE ADVANCING AND DEPLOYING THE SECOND ONE. THEY USED ONE MORE EMBOLD 60CM PACKING COIL AFTER THAT AND A FEW MORE EMBOLD COILS AND FINISHED THE CASE. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).