ASPIRA®
Received May 1, 2026 · Event occurred Mar 20, 2026
Report 3011642792-2026-00039 · MDR key 25055167
Device
Generic name
Peritoneal, Drainage Catheter For Refractory Ascites, Long-term Indwelling
Manufacturer
Merit Medical Systems, Inc.Catalog number
4992207/A
Product problems
- Device Dislodged or Dislocated
- Incomplete or Inadequate Connection
Patient
NA · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE SUSPECT DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY AND COMPLAINT DATABASE COULD NOT BE PERFORMED SINCE THE LOT NUMBER WAS NOT PROVIDED. NONCONFORMANCES OF THIS NATURE ARE MONITORED BY THE OPERATION TEAM. SINCE THIS EVENT OCCURRED IN GERMANY (PART NUMBER ASP-4/B), THIS IS REPORTED ON THE SAME/SIMILAR PART NUMBER (4992207/A) THAT IS APPROVED FOR DISTRIBUTION IN THE UNITED STATES.
Description of Event or Problem
PATIENT EXPERIENCE REPORT INVOLVING THE ASPIRA® PRODUCT FAMILY INCLUDED A REPORT INVOLVING A MALE PATIENT AGED 18 YEARS OR OLDER WHERE THEY EXPERIENCED THE CATHETER HAVING SLOW TO NO DRAINAGE AND IT CAME OUT BY ACCIDENT. THE CATHETER WAS LOCATED IN THE ABDOMEN FOR DRAINAGE.