BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING¿

    MDR report key: 2980861 · Received February 27, 2013

    Report

    Report Number
    2134265-2013-01047
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    January 31, 2013
    Report Date
    February 1, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K053116
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: THE BALLOON WAS DEFLATED, AS-RECEIVED. THERE WAS NO EVIDENCE OF ANY PROXIMAL BOND ANOMALIES OR DISTAL OUTER NECKDOWN. A .018" GUIDEWIRE WAS INSERTED INTO THE TIP AND ADVANCED THROUGH THE LUMEN. THE DEVICE WAS INFLATED TO RATED BURST PRESSURE (RBP) WITH AN INFLATION DEVICE FILLED WITH WATER; NO ISSUES WERE ENCOUNTERED DURING INFLATION. THE DEVICE MAINTAINED RBP WITH NO INDICATION OF ANY LEAKS OR OTHER IRREGULARITIES. AFTER CONFIRMING THE DEVICE MAINTAINED RBP, THE DEVICE WAS DEFLATED BY APPLYING NEGATIVE PRESSURE WITH THE INFLATION DEVICE. THE DEVICE DEFLATED WITHIN SPECIFICATION. FUNCTIONAL TESTING OF INFLATION AND DEFLATION PERFORMANCE REVEALED NO EVIDENCE OF THE ALLEGED INFLATION DIFFICULTY. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS NOT CONFIRMED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION A BALLOON DEFLATION ISSUE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE TARGET LESION WAS IN THE MODERATELY TORTUOUS AORTIC VALVE. THE 6.0 X 40MM STERLING OTW BALLOON WAS INFLATED 1ST AT 6ATMS, BUT THE LESION WAS NOT DILATED ENOUGH. THE BALLOON WAS INFLATED 2ND TO 14ATMS. UPON DEFLATION THE PHYSICIAN FELT AS THOUGH THE DEFLATION SPEED WAS SLOW. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION A BALLOON DEFLATION ISSUE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE TARGET LESION WAS IN THE MODERATELY TORTUOUS AORTIC VALVE. THE 6.0 X 40MM STERLING OTW BALLOON WAS INFLATED 1ST AT 6ATMS, BUT THE LESION WAS NOT DILATED ENOUGH. THE BALLOON WAS INFLATED 2ND TO 14ATMS. UPON DEFLATION THE PHYSICIAN FELT AS THOUGH THE DEFLATION SPEED WAS SLOW. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85692 STERLING¿ CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H74939032604010 14950179

    Patients

    Seq Age Sex Outcome Treatment
    1