PIAB: 8 FR - 30 CC FOS

MDR report key: 2803144 · Received October 19, 2012

Report

Report Number: 1219856-2012-00309
Event Type: Malfunction
Date Received: October 19, 2012
Date of Event: September 24, 2012
Report Date: October 19, 2012
Manufacturer: ARROW INTERNATIONAL INC
Product Code: DSP
PMA / PMN Number: K021462
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GR
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 THE EVENT INVOLVED A MALE PT WHILE IN THE CATH LAB DURING INSERTION. INDICATIONS FOR USE: END STAGE HEART FAILURE. THE MD INSERTED THE INTRA-AORTIC BALLOON (IAB) VIA RIGHT FEMORAL ARTERY WITH NO ISSUES. AFTER CONNECTING THE FIBER OPTIC PROPERLY TO THE INTRA-AORTIC BALLOON PUMP (IABP), THE MD ADVANCED THE IABP), THE MD ADVANCED THE IAB SMOOTHLY WITHOUT ANY ISSUES IN THE DESCENDING AORTA UNDER FLUOROSCOPIC GUIDANCE. THE MD DIDN'T USE A SHEATH. WHEN THE IAB WAS AT THE CORRECT POSITION AND THEY WERE READY TO START PUMPING, THE DIDN'T SEE ANY ARTERIAL BLOOD PRESSURE ON THE PUMP SCREEN. WITHIN A FEW MINUTES BLOOD WAS OBSERVED IN THE IAB. AS A RESULT, THE IAB WAS IMMEDIATELY REMOVED. THERE WAS NOT ANOTHER ATTEMPT AT THE PROCEDURE. THERE WAS A DELAY OR INTERRUPTION IN THERAPY WITH NO HARM TO THE PT. NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. THE PT OUTCOME IS THE PT IS STILL ALIVE. IT WAS DISCOVERED THAT THE FIBER OPTIC WIRE WAS DISPLACED TOWARDS THE BALLOON PENETRATING THE BALLOON WHICH RESULTED IN A SMALL HOLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PIAB: 8 FR - 30 CC FOS	INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM (FOS)	DSP	ARROW INTERNATIONAL INC		KF2053288

Patients

Seq	Age	Sex	Outcome	Treatment
1	58 YR			PENRAZOL\| PRAVACHOL\| ALDACTONE\| LASIX\| PROCOROLAN\| PLAVIX