FDA Adverse Event Malfunction Summary report: N

ENCORE BALLOON CATHETER INFLATION DEVICE

MDR report key: 1982867 · Received February 9, 2011

Report

Report Number: 2134265-2011-00194
Event Type: Malfunction
Date Received: February 9, 2011
Date of Event: January 14, 2011
Report Date: January 14, 2011
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 EVALUATION: THE UNIT AND UNIT COMPONENTS WERE VISUALLY EXAMINED FOR ANY DAMAGE OR DEFECT AND NO VISUAL DEFECTS WHERE OBSERVED. THE UNIT WAS FUNCTIONALLY EXAMINED AND NO ISSUES WERE NOTED DURING TESTING. THE ACCURACY OF THE GAUGE UNDER PRESSURIZATION AND AT 0 PRESSURE MET SPECIFICATIONS AND THERE WAS NO SLIPPAGE OF THE NEEDLE. 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 AND/OR PROCEDURAL FACTORS. (B)(4)

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, THE PRESSURE GAUGE DID NOT READ ACCURATELY. THE 99% STENOTIC LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. WHEN THE PHYSICIAN WAS PRESSURIZING WITH THE ENCORE26 INFLATION DEVICE ON THE FIRST INFLATION THE BALLOON WAS INFLATED ABOVE 16ATMS, BUT THE PRESSURE GAUGE READ 16ATMS AND DID NOT GO UP MORE THAN 16ATMS. THE PROCEDURE WAS COMPLETED WITH ANOTHER ENCORE26 INFLATION DEVICE. NO 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	13814326

Patients

Seq	Age	Sex	Outcome	Treatment
1