FDA Adverse Event Injury Summary report: N

CELT ACD VASCULAR CLOSURE DEVICE

MDR report key: 8690643 · Received June 12, 2019

Report

Report Number: 3009984513-2019-00002
Event Type: Injury
Date Received: June 12, 2019
Date of Event: June 8, 2018
Report Date: June 12, 2019
Manufacturer: VASORUM LTD
Product Code: MGB
UDI-DI: 05391530280068
PMA / PMN Number: P150006
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: SZ
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

1- DURING THE PROCESSING OF THIS COMPLAINT ALL ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. 2- THIS REPORT IS THE FINAL REPORT BEING SUBMITTED BY VASORUM UNLESS OTHERWISE REQUESTED BY THE FDA. 3- VASORUM LTD IS SUBMITTING THIS REPORT ON BEHALF OF DJ MEDICAL CONSULTING & DISTRIBUTION LLC, IN ACCORDANCE WITH THE CONDITIONS OUTLINED WITH THE MDR EXEMPTION E2017048. VASORUM LTD TRINITAS HOUSE 2012 ORCHARD AVENUE CITYWEST BUSINESS PARK D24 WPW6 DUBLIN - IRELAND DJ MEDICAL CONSULTING AND DISTRIBUTION LLC 20 RYANS LANE DUXBURY MA 02332 USA

Description of Event or Problem · 0

ACCORDING TO THE DOCTOR, HE TURNED THE HANDLE CLOCKWISE, IT MADE THE 'CLICK', EVERYTHING SEEMED NORMAL BUT THE SET OF WINGS DIDN'T OPEN. WHEN PULLING BACK THE INSTRUMENT, THERE WAS NO RESISTANCE AND THE TUBE SLIPPED OUT AND THE PATIENT SUFFERED A BIG BLOOD LOSS. AS THERE WAS NO RESISTANCE DUE TO NOT OPENING OF THE INNER 'STAR' BY PULLING EVERYTHING AGAINST THE ARTERIAL WALL, CELT DEVICE AND INTRODUCER SHEATH CAME OUT OF THE PATIENT AND THEN CLOSED BY MANUAL COMPRESSION. THE IMPLANT WAS DEPLOYED AFTER THE DEVICE WAS PULLED OUT OF PATIENT. IT WAS A CARDIAC PROCEDURE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
484890	CELT ACD VASCULAR CLOSURE DEVICE	VASCULAR CLOSURE DEVICE	MGB	VASORUM LTD	KCLT-06	492153	05391530280068

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention