BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERIPHERAL CUTTING BALLOON

    MDR report key: 2032559 · Received March 29, 2011

    Report

    Report Number
    2134265-2011-01263
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    February 25, 2011
    Report Date
    February 28, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K041993
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: A VISUAL EXAMINATION OF THE DEVICE FOUND THAT THE RETURNED BALLOON SHOWED EVIDENCE OF BEING INFLATED WITH BLOOD IN THE BALLOON AND SHAFT. THE SHAFT WAS STRETCHED FOR A LENGTH OF 15MM, 485MM-500MM FROM THE DISTAL TIP OF THE DEVICE, CAUSING THE OUTER TO NECK DOWN ON THE INNER LUMEN RESTRICTING THE INFLATION/DEFLATION PATH. A MICROSCOPIC EXAMINATION OF THE PROXIMAL BOND OBSERVED NO DAMAGE. THERE WAS NO DAMAGE NOTED TO THE BALLOON. A CLEAR INFLATION/DEFLATION PATH WAS EVIDENT AT THE PROXIMAL BOND. THE DEVICE WAS ATTACHED TO AN ENCORE INFLATION UNIT AND AN ATTEMPT WAS MADE TO INFLATE THE DEVICE TO ITS RATED BURST PRESSURE (RBP). THE DEVICE COULD NOT BE INFLATED DUE TO THE STRETCHING IN THE SHAFT. NO OTHER DAMAGE TO THE DEVICE WAS NOTED. 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FISTULA DECLOTTING PROCEDURE, BALLOON DEFLATION DIFFICULTIES OCCURRED. THE STENOSED LESION WAS LOCATED IN THE PROXIMAL SUBCLAVIAN VEIN. FOLLOWING PREDILATION WITH A 4.0X4.0MM BALLOON, THE 2.0X8.0MM PERIPHERAL CUTTING BALLOON WAS INFLATED 3 TIMES SUCCESSFULLY TO 8 ATMS. ON THE 4TH INFLATION, THE PHYSICIAN WAS UNABLE TO DEFLATE THE BALLOON AND RETRACT THE BLADES. A CHIBA NEEDLE WAS USED TO POP THE BALLOON PERCUTANEOUSLY AND THE BALLOON WAS REMOVED WITHOUT INJURY TO THE PATIENT. THERE WAS A 15 MINUTE DELAY OF PROCEDURE. A 4.0X4.0MM "PLASTY" WAS DONE TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS WAS LISTED AS OKAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FISTULA DECLOTTING PROCEDURE, BALLOON DEFLATION DIFFICULTIES OCCURRED. THE STENOSED LESION WAS LOCATED IN THE PROXIMAL SUBCLAVIAN VEIN. FOLLOWING PREDILATION WITH A 4.0X4.0MM BALLOON, THE 2.0X8.0MM PERIPHERAL CUTTING BALLOON WAS INFLATED 3 TIMES SUCCESSFULLY TO 8 ATMS. ON THE 4TH INFLATION, THE PHYSICIAN WAS UNABLE TO DEFLATE THE BALLOON AND RETRACT THE BLADES. A CHIBA NEEDLE WAS USED TO POP THE BALLOON PERCUTANEOUSLY AND THE BALLOON WAS REMOVED WITHOUT INJURY TO THE PATIENT. THERE WAS A 15 MINUTE DELAY OF PROCEDURE. A 4.0X4.0MM "PLASTY" WAS DONE TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS WAS LISTED AS OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERIPHERAL CUTTING BALLOON CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA LIT BOSTON SCIENTIFIC - GALWAY M001PCB80201350 13887299

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention BBRAUN INFLATION DEVICE