FDA Adverse Event Injury Summary report: N

AXERA 2 ACCESS SYSTEM

MDR report key: 2921727 · Received January 15, 2013

Report

Report Number: 3008493244-2013-00003
Event Type: Injury
Date Received: January 15, 2013
Date of Event: December 20, 2012
Report Date: December 20, 2012
Manufacturer: ARSTASIS INC.
Product Code: DYB
PMA / PMN Number: K121521
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MI, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE WAS NOT RETURNED; THEREFORE, PRODUCT FAILURE ANALYSIS WAS NOT POSSIBLE. PHOTOS RECEIVED CONFIRMED THE DESCRIPTION OF THE EVENT. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THIS LOT AND NO NONCONFORMING MATERIAL REPORTS HAVE BEEN INITIATED THAT ARE RELATED TO THIS FAILURE MODE. THE AXERA 2 ACCESS SYSTEM INSTRUCTIONS FOR USE (IFU), WAS REVIEWED. DISSECTION IS A KNOWN POSSIBLE ADVERSE EFFECT OF VASCULAR ACCESS PROCEDURES AND IS LISTED IN THE ADVERSE EFFECTS SECTION OF THE PRODUCT IFU. THE IFU PROVIDES THE APPROPRIATE INSTRUCTIONS ON DEVICE USAGE, WARNINGS AND PRECAUTIONS; THEREFORE, NO UPDATE IS REQUIRED. BASED ON THE REVIEW COMPLETED, THERE IS NO INDICATION THE DEVICE WAS OUT OF SPECIFICATION. THE ROOT CAUSE, BASED ON AVAILABLE INFORMATION, IS UNKNOWN AS IT CANNOT BE DEFINITIVELY DETERMINED.

Description of Event or Problem · 1

THIS WAS A DIAGNOSTIC CASE (RIGHT/LEFT HEART CATHETERIZATION). NO CALCIFICATION, SCARRING, OR TORTUOSITY WAS OBSERVED. THE PHYSICIAN DID NOT HAVE DIFFICULTY INSERTING THE AXERA DEVICE. FOLLOWING SHEATH INSERTION, ANGIOGRAPHY REVEALED A DISSECTION (PROXIMAL, APPROXIMATELY 4-6 MM, TO AXERA INSERTION SITE). NO TREATMENT FOR THE DISSECTION WAS REQUIRED. THE PATIENT RECOVERED WITH NO FURTHER SEQUELAE AND WAS DISCHARGED ON (B)(6) 2012.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
22946	AXERA 2 ACCESS SYSTEM	INTRODUCER CATHETER	DYB	ARSTASIS INC.		12J05177

Patients

Seq	Age	Sex	Outcome	Treatment
1	58 YR		Hospitalization