DeathDRE
13FR MECHANICAL DILATOR SHEATH SET
Received Dec 2, 2013 · Event occurred Nov 18, 2013
Report MW5033199 · MDR key 3499808
Device
Generic name
13fr Mechanical Dilator Sheath Set
Manufacturer
Cook Vascular IncCatalog number
LR-EVN-13.0
Lot number
N100925
Product problems
- Difficult to Remove
Patient
89 YR
- Death
- Exsanguination
Narrative
Description of Event or Problem
PT EXPIRED DURING PROCEDURE IN CATH LAB. PHYSICIAN HAD DIFFICULTY REMOVING A LEAD WITH POSSIBLE ADHESION OF LEAD TO THE SUPERIOR VENA CAVA. RESULTED IN WHAT APPEARED TO BE ...