FDA Adverse Event Malfunction Summary report: N

ENCORE BALLOON CATHETER INFLATION DEVICE

MDR report key: 1896941 · Received November 11, 2010

Report

Report Number: 2134265-2010-05191
Event Type: Malfunction
Date Received: November 11, 2010
Date of Event: October 13, 2010
Report Date: October 13, 2010
Manufacturer: BOSTON SCIENTIFIC - CORK
Product Code: MAV
PMA / PMN Number: K955869
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

DEVICE EVALUATED BY MANUFACTURER: THE UNIT COMPONENTS WERE VISUALLY EXAMINED FOR ANY DAMAGE OR DEFECT. NO VISUAL DEFECTS WHERE NOTED WITH THE UNIT OR UNIT COMPONENTS. THE UNIT WAS FUNCTIONALLY EXAMINED. NO AIR BUBBLES WERE EMITTED FROM THE DEVICE. THERE WAS NO SLIPPAGE OF THE NEEDLE. THERE WERE NO SELF RELEASING ISSUES. THERE WAS NO BUBBLE LEAKAGE. NO ISSUES WERE NOTED DURING THE FUNCTIONAL TESTING OF THE COMPLAINT DEVICE THAT WOULD CONFIRM THE EVENT DESCRIPTION. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE THERE WAS AN UNINTENDED INCREASE OF ATM'S. THE ENCORE INFLATION DEVICE WAS BEING USED AND PRESSURE WAS BETWEEN 2 AND 3 ATMOSPHERES WHEN IT SUDDENLY INCREASED TO 12 ATMOSPHERES. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ENCORE BALLOON CATHETER INFLATION DEVICE	SYRINGE, BALLOON INFLATION	MAV	BOSTON SCIENTIFIC - CORK	H74904526011	0013714696

Patients

Seq	Age	Sex	Outcome	Treatment
1