FDA Adverse Event Injury Summary report: N

CELT ACD VASCULAR CLOSURE DEVICE

MDR report key: 23309726 · Received October 16, 2025

Report

Report Number: 3009984513-2025-00009
Event Type: Injury
Date Received: October 16, 2025
Date of Event: September 16, 2025
Report Date: October 15, 2025
Manufacturer: VASORUM LTD.
Product Code: MGB
PMA / PMN Number: P150006
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: GA, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

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 NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. THE DEVICE WAS NOT RETURNED TO VASORUM LTD. FOR EXAMINATION. BASED ON THE INFORMATION RECEIVED VASORUM CONCLUDES THAT THE IMPLANT REMAINS BEHIND IN THE PATIENT. 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 THAT THE PHYSICIAN WAS CONDUCTING A ROUTINE DIAGNOSTIC PROCEDURE AT HIS OUTPATIENT LAB. TYPICALLY, HE OR HIS TECHNICIAN CLOSES PATIENTS USING THE CELT PLUS DEVICE. ON THIS OCCASION, A NEW TECHNICIAN, WHO HAD NO PRIOR EXPERIENCE WITH THE DEVICE, PERFORMED THE CLOSURE. DURING THE PROCEDURE, THE CELT PLUS DEVICE EMBOLIZED AND BECAME LODGED IN THE POPLITEAL ARTERY. THE PATIENT EXHIBITED STRONG PULSES AND SUFFICIENT BLOOD FLOW AROUND THE EMBOLIZED DEVICE AND WAS DISCHARGED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2535350	CELT ACD VASCULAR CLOSURE DEVICE	VASCULAR CLOSURE DEVICE	MGB	VASORUM LTD.

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown	Other