MalfunctionOFL
TRANSCAROTID/PERIPHERAL ACCESS KIT
Received Jun 30, 2026
Report 1649395-2026-00003 · MDR key 25667496
Device
Product problems
- Material Integrity Problem
Patient
0 DA · Unknown
- Embolism/Embolus
Narrative
Description of Event or Problem
DR. (B)(6) UTILIZED THE TUNNEL TECHNIQUE AND WENT DIRECTLY INTO THE SKIN WITH THE MPK NEEDLE AND THEN FOLLOWED WITH THE MPK SHEATH WITH THE NON-STIFFENED DILATOR. SHE HAD PUSH ABILITY ISSUES AND COULD NOT SEE THE CM MARKING AT HER ACCESS SITE. IT WAS DECIDED TO SWITCH TO THE STIFFENED DIALATOR AND UPON PULLING OUT THE SHEATH, SHE REALIZED THE MARKING WERE NO LONGER ON THE SHEATH.
Remedial action
- Recall