MalfunctionOWQ
ACUNAV DIAGNOSTIC ULTRASOUND
Received Dec 1, 2021 · Event occurred Nov 19, 2021
Report 12908000 · MDR key 12908000
Device
Generic name
Reprocessed Intravascular Ultrasound Catheter
Manufacturer
Sterilmed, Inc.Model number
ACU10135936Catalog number
ACU10135936
Lot number
2156596
Product problems
- Material Twisted/Bent
Patient
28105 DA · Female
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
FAULTY PRODUCT, BENT CATHETER TIP NOTED UPON OPENING EQUIPMENT.