InjuryFBQ
COOK BRAND TRANSEPTAL NEEDLE
Received Apr 16, 2019 · Event occurred Apr 2, 2019
Report MW5085939 · MDR key 8523190
Device
Product problems
- Defective Device
- Difficult to Advance
Patient
61 YR
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE 2 COOKS TRANS-SEPTAL NEEDLES FROM THIS LOT WOULD NOT PASS THROUGH THE SHEATH (2 DIFFERENT SHEATHS ATTEMPTED). WHEN THEY TRIED A NEW NEEDLE LOT, IT WORKED FINE. THERE WAS NO HARM TO THE PT. THE DEFECTIVE LOT APPEARS TO HAVE A DIFFERENT CURVATURE. FDA SAFETY REPORT ID# (B)(4).