FDA Adverse Event Injury Summary report: N

CELT ACD PLUS VASCULAR CLOSURE DEVICE

MDR report key: 25123673 · Received May 8, 2026

Report

Report Number: 3009984513-2026-00006
Event Type: Injury
Date Received: May 8, 2026
Date of Event: December 25, 2025
Report Date: May 8, 2026
Manufacturer: VASORUM LTD
Product Code: MGB
UDI-DI: 05391530280617
PMA / PMN Number: P150006
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

DURING PROCESSING OF THIS COMPLAINT AN ATTEMPT WAS MADE TO OBTAIN COMPLETE EVENT INFORMATION. A SEARCH OF THE COMPLAINT FILES WAS COMPLETED, AND NO OTHER COMPLAINTS WERE IDENTIFIED WITH THE SAME LOT NUMBER. THE DEVICE WAS NOT RETURNED TO VASORUM LTD FOR EXAMINATION. THE IMPLANT REMAINS IN THE PATIENT. THIS INCIDENT RESULTED IN NO PATIENT HARM AS NO FURTHER PROCEDURE WAS REQUIRED AND THE PATIENT HAD NO SYMPTOMS. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN THE CUSTOMER COMPLAINT FILES OF VASORUM LTD. FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP. NO CORRECTIVE/PREVENTATIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS REPORT IS THE FINAL REPORT BEING SUBMITTED BY VASORUM LTD.

Description of Event or Problem · 0

IT WAS REPORTED VIA MEDSUN THAT A CELT PLUS 5F IMPLANT WAS EMBOLIZED ON RELEASE FROM THE DELIVERY SYSTEM INTO A BRANCH OF THE COMMON FEMORAL ARTERY. THE POSITION OF THE IMPLANT IN THE SIDE BRANCH WAS STABLE, AND THE LOCATION WAS DEEMED BY THE OPERATOR NOT TO BE HARMFUL FOR THE PATIENT. NO ATTEMPT WAS MADE TO RETRIEVE THE IMPLANT. THE PATIENT WAS INFORMED AND HAD NO SYMPTOMS. HAEMOSTASIS WAS ACHIEVED BY MANUAL PRESSURE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
579940	CELT ACD PLUS VASCULAR CLOSURE DEVICE	VASCULAR CLOSURE DEVICE	MGB	VASORUM LTD	CLT-05	943577	05391530280617

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown	Other