MalfunctionOWQ
SOUNDSTAR ECO
Received Sep 18, 2024 · Event occurred May 31, 2024
Report 20245211 · MDR key 20245211
Device
Generic name
Reprocessed Intravascular Ultrasound Catheter
Manufacturer
Sterilmed, Inc.Model number
BIO10438577Catalog number
BIO10438577
Lot number
2203304
Patient
1 MO · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
CATHETER TIP WOULD NOT ENGAGE, ALLOWING IT TO FLEX. THE PLUNGER HANDLE IS HARD TO MANIPULATE.