WRAPSODY¿
Received Jul 28, 2026 · Event occurred Feb 21, 2024
Report 1721504-2026-00360 · MDR key 50053813
Device
Generic name
Catheter, Continuous Flush
Manufacturer
Merit Medical Systems, Inc.Catalog number
WRAP-L08125/EUA
Lot number
H2552691
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Unknown
- Thrombosis/Thrombus
Narrative
Description of Event or Problem
It was reported via clinical trial that a patient was unable to complete their hemodialysis session due to proximal obstruction and was admitted to the hosptial for severe thrombosis. The patient was treated with surgical thrombectomy and revision of fistula with basilic transposition. The event was considered resolved and the subject was subsequently discharged from the hospital. The event is considered possible device related and not related to procedure.
Additional Manufacturer Narrative
The investigation is ongoing. If additional reportable information becomes available, it will be submitted in a supplemental report.