IAB : 8 FR - 40 CC FOS

MDR report key: 2426100 · Received January 17, 2012

Report

Report Number: 1219856-2012-00011
Event Type: Death
Date Received: January 17, 2012
Date of Event: December 24, 2011
Report Date: January 17, 2012
Manufacturer: ARROW INTL., INC.
Product Code: DSP
PMA / PMN Number: K021462
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem · 1

IT WAS REPORTED THAT WHILE IN THE CARDIAC OPERATING ROOM, THE MD INSERTED THE INTRA-AORTIC BALLOON (IAB) VIA A SHEATH INTO THE PATIENT'S FEMORAL ARTERY. AFTER THE IAB WAS INSERTED, THE ATTENDING PERFUSIONIST NOTICED A MINUTE AMOUNT OF THE PATIENT'S BLOOD IN THE IAB LUMEN. THE MD DECIDED TO LEAVE THE BALLOON IN PLACE AS THERE WERE NO ALARMS. THE PATIENT DIED. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2012 FROM RN, (B)(4) STATED, "THE PATIENT OUTCOME WAS NOT FAVORABLE, HOWEVER, THE STAFF DO NOT FEEL THAT THE IAB CONTRIBUTED TO THE PATIENT'S DEMISE." INFORMATION ALSO RECEIVED ON THE SAME DAY STATED IT IS THE OPINION OF (B)(6) CARDIAC PERFUSION, CARDIAC OPERATING ROOM, THAT "THE POSSIBLE BALLOON PUNCTURE WAS MOST PROBABLY CAUSED BY THE PATIENT'S CALCIFIED ARTERIAL ANATOMY."

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	IAB : 8 FR - 40 CC FOS	INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM (FOS)	DSP	ARROW INTL., INC.		NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNKNOWN		Death