AXERA ACCESS SYSTEM

Report

Report Number: 3008493244-2011-00032
Event Type: Injury
Date Received: September 13, 2011
Date of Event: August 8, 2011
Report Date: August 16, 2011
Manufacturer: ARSTASIS INC.
Product Code: DYB
PMA / PMN Number: K103143
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE WAS NOT RETURNED; THEREFORE, FAILURE ANALYSIS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD AND COMPLAINT HISTORY FOR THIS LOT WAS NOT PERFORMED AS THE LOT NUMBER WAS NOT REPORTED. HOWEVER, NON CONFORMING MATERIALS REPORT (NCMR) HISTORY FROM THE LAST 6 MONTHS WAS REVIEWED AND NO NCMRS HAVE BEEN INITIATED THAT ARE RELATED TO THIS FAILURE MODE. THE INSTRUCTIONS FOR USE WAS REVIEWED AND PSEUDOANEURYSM IS LISTED AS A POSSIBLE COMPLICATION. BASED ON AVAILABLE INFORMATION, THERE IS NO INDICATION THAT THE IFU WAS NOT FOLLOWED. BASED ON THE ANALYSIS COMPLETE, THERE IS NO EVIDENCE TO SUFFEST THE DEVICE WAS OUT OF SPECIFICATION. THE PROBABLE ROOT CAUSE OF THE REPORTED PSEUDOANEURYSM IS UNKNOWN.

Description of Event or Problem · 1

THE PHYSICIAN PERFORMED A DIAGNOSTIC INDEX PROCEDURE THROUGH THE COMMON FEMORAL ARTERY OF AN AVERAGE SIZE MALE PATIENT. THE PROCEDURE WAS UNREMARKABLE WITH NO TORTUOSITY OR CALCIFICATION OF THE VESSEL, AND THE ACCESS SITE OF THE AXERA DEVICE WAS REPORTED TO BE CORRECT. THE EVENING AFTER THE PROCEDURE A RE-BLEED AT THE ACCESS SITE WAS REPORTED, AND A SECOND RE-BLEED WAS REPORTED 7.5 HOURS LATER IN THE MORNING. BY MID-AFTERNOON THE SUBJECT HAD A SCAN AND IT WAS DETERMINED THAT THERE WAS A PSEUDOANEURYSM NEAR THE ACCESS SITE. THE PSEUDOANEURYSM WAS TREATED WITH A THROMBIN INJECTION. THE PATIENT WAS OK AT DISCHARGE WHICH OCCURRED 2 TO 3 DAYS AFTER THE INDEX PROCEDURE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	AXERA ACCESS SYSTEM	INTRODUCER CATHETER	DYB	ARSTASIS INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention