PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM

MDR report key: 1244224 · Received November 25, 2008

Report

Report Number: 3004114958-2008-00022
Event Type: Injury
Date Received: November 25, 2008
Date of Event: November 12, 2008
Report Date: November 12, 2008
Manufacturer: CARDICA, INC
Product Code: FZP
PMA / PMN Number: K081225
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NH, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

PHYSICIAN THINKS HE WAS PRESSING DOWN TOO HARD ON THE AORTA DURING THE DEPLOYMENT, WHICH WOULD HAVE CAUSED THE EVENT.

Description of Event or Problem · 1

SURGEON WAS PERFORMING A CABG X 3 PROCEDURE. PAS-PORT DEVICE WAS USED DURING THE PROCEDURE. PAS-PORT DEVICE WAS LOADED WITHOUT INCIDENT. DEVICE WAS PLACED ONTO THE AORTA AND DEPLOYED. POST FIRE INSPECTION WAS PERFORMED AND THE IMPLANT APPEARED TO HAVE CAUGHT THE BACKWALL OF THE AORTA.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM	CARDIOVASCULAR SURGICAL INSTRUMENT	FZP	CARDICA, INC	FG-000001-08	80812B

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other