6F ANGIO-SEAL EVOLUTION

MDR report key: 2844417 · Received November 16, 2012

Report

Report Number: 2182269-2012-00124
Event Type: Injury
Date Received: November 16, 2012
Date of Event: October 18, 2012
Report Date: November 7, 2012
Manufacturer: ST. JUDE MEDICAL
Product Code: MGB
PMA / PMN Number: P930038
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

ADD¿L INFO ABOUT THE INCIDENT IS EXPECTED. UPON COMPLETION OF THE INVESTIGATION, AN ADD¿L MEDWATCH WILL BE FILED.

Description of Event or Problem · 1

A 6F ANGIO-SEAL EVOLUTION WAS DEPLOYED FOLLOWING A DIAGNOSTIC CARDIAC ANGIOGRAM. THE PHYSICIAN REPORTED THAT DURING WITHDRAWAL OF THE DEVICE THE TENSION WAS NOT THE SAME AS USUAL, AND THE DEVICE FELT LOOSE INSIDE THE PT. THE PT REPORTEDLY FELT SOME PAIN DURING DEPLOYMENT, BUT HEMOSTASIS WAS INSTANTLY ACHIEVED. THE PT WAS SUPINE FOR ONE HOUR AND WAS DISCHARGED THE NEXT DAY. FOUR DAYS LATER, THE PT REPRESENTED AT THE HOSPITAL AND WAS ADMITTED OVERNIGHT FOLLOWING THE IDENTIFICATION OF A LARGE HEMATOMA. AN ULTRASOUND REVEALED THAT A PSEUDOANEURYSM HAD DEVELOPED. MANUAL COMPRESSION WAS APPLIED BUT WAS NOT THOUGHT TO BE SUCCESSFUL SINCE A PSEUDOANEURYSM WAS STILL NOTED THE FOLLOWING DAY. FURTHER COMPRESSION WAS APPLIED AND THE PT WAS DISCHARGED. A FOLLOW-UP EXAMINATION SHOWED THAT THE PSEUDOANEURYSM HAD RESOLVED AND THE PT WAS FINE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	6F ANGIO-SEAL EVOLUTION	DEVICE, HEMOSTATASIS, ABSORBABLE	MGB	ST. JUDE MEDICAL	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention