BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING?

    MDR report key: 2993377 · Received March 7, 2013

    Report

    Report Number
    2134265-2013-01731
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 26, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K053118
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE STERLING CATHETER WAS RECEIVED INSIDE A STERLING PRODUCT POUCH AND SHELF BOX THAT MATCHED THE INFORMATION ON THE DEVICE. THERE WAS BLOOD IN THE BALLOON AND INFLATION LUMEN. MAGNIFIED INSPECTION REVEALED A LONGITUDINAL TEAR IN THE BALLOON WALL ON THE DISTAL END OF THE BALLOON. THERE WERE NO IRREGULARITIES IN THE BALLOON MATERIAL OR THE RO MARKER THAT COULD HAVE CONTRIBUTED TO THE DAMAGE. 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 PERIPHERAL INTERVENTION, BALLOON RUPTURE OCCURRED. ACCESS WAS OBTAINED VIA LEFT BRACHIAL ARTERY. THE 100% STENOSED MODERATELY CALCIFIED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS LEFT COMMON FEMORAL ARTERY. A 3.0 MM X 20 MM X 135 CM STERLING BALLOON WAS USED FOR PRE-DILATATION. THE BALLOON WAS INFLATED THREE TIMES: 1ST AND 2ND AT 6 ATM AND 10 ATM RESPECTIVELY. THE THIRD INFLATION WAS AT 13 ATM AND THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A 5.5 MM X 30 MM STERLING BALLOON CATHETER. NO PATIENT COMPLICATION WAS REPORTED AND THE PATIENT STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS PERIPHERAL INTERVENTION, BALLOON RUPTURE OCCURRED. ACCESS WAS OBTAINED VIA LEFT BRACHIAL ARTERY. THE 100% STENOSED MODERATELY CALCIFIED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS LEFT COMMON FEMORAL ARTERY. A 3.0MMX20MMX135CM STERLING BALLOON WAS USED FOR PRE-DILATATION. THE BALLOON WAS INFLATED THREE TIMES: 1ST AND 2ND AT 6 ATM AND 10 ATM RESPECTIVELY. THE THIRD INFLATION WAS AT 13 ATM AND THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A 5.5MMX30MM STERLING BALLOON CATHETER. NO PATIENT COMPLICATION WAS REPORTED AND THE PATIENT STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97296 STERLING? CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H74939031302010 14054422

    Patients

    Seq Age Sex Outcome Treatment
    1