FDA Adverse Event Injury Summary report: N

CELT ACD VASCULAR CLOSURE DEVICE

MDR report key: 21796593 · Received April 8, 2025

Report

Report Number: 3009984513-2025-00004
Event Type: Injury
Date Received: April 8, 2025
Date of Event: March 31, 2025
Report Date: April 8, 2025
Manufacturer: VASORUM LTD.
Product Code: MGB
PMA / PMN Number: P150006
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. A SEARCH OF THE COMPLAINT FILES DID NOT FIND ANY OTHER REPORT WITH THE LOT NUMBER (943192). THE DEVICE WAS NOT RETURNED TO VASORUM LTD. FOR EXAMINATION. 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 UNLESS REQUESTED BY THE FDA.

Description of Event or Problem · 0

IT WAS REPORTED THAT THE DOCTOR OPENED FIRST DISC OF DEVICE AND PULLED BACK TO WHAT HE THOUGHT TO BE ARTERIOTOMY DESPITE SALES REPRESENTATIVE AND SCRUB TECHNICIAN SAYING THEY SHOULD PULL BACK MORE. THE DOCTOR THEN MOVED TO A 90-DEGREE ANGLE TO OPEN SECOND DISC AND DEPLOYED WITH CONFIDENCE. THE DEVICE WAS SUBSEQUENTLY DEPLOYED AND EJECTED INTO BLOOD STREAM WHICH RESULTED IN THE DEVICE ENDING UP IN PROFUNDA. MANUAL PRESSURE WAS APPLIED UNTIL HEMOSTASIS WHILE ALL PULSES WERE DOCUMENTED IMMEDIATELY. IMPLANT WAS NOT RETRIEVED AND PATIENT WAS REPORTED TO BE STABLE WITH NO COMPLICATIONS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
446745	CELT ACD VASCULAR CLOSURE DEVICE	VASCULAR CLOSURE DEVICE	MGB	VASORUM LTD.	KCLT-06	943192

Patients

Seq	Age	Sex	Outcome	Treatment
1	74 YR	Male	Required Intervention