BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL PERIPHERAL CUTTING BALLOON

    MDR report key: 2079327 · Received May 5, 2011

    Report

    Report Number
    2134265-2011-01554
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Report Date
    April 8, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LOX
    PMA / PMN Number
    P950020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTIONS: BRAND NAME FROM CUTTING BALLOON TO SMALL PERIPHERAL CUTTING BALLOON. COMMON DEVICE NAME FROM CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING TO CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS. PRODUCT CODE FROM NWX TO LOX. UPN SEARCH FROM M001BPM4015140F0 TO M001BPM4015140F0. PMA # OR 510K # FROM NA TO P950020. DEVICE EVALUATED BY MFR: A VISUAL EXAMINATION OF THE DEVICE FOUND THAT THE DEVICE WAS RETURNED WITH THE BALLOON DETACHED. THE BALLOON AND BALLOON PROTECTOR CAP WAS NOT RETURNED WITH THE DEVICE. THE BALLOON HAD DETACHED FROM THE OUTER DISTAL AT THE PROXIMAL BOND AND FROM THE INNER LUMEN AT THE DISTAL BOND. THEY HYPOTUBE SHAFT WAS KINKED 396MM FROM THE DISTAL END OF THE SPIRAL STRAIN RELIEF. NO OTHER DAMAGE WAS NOTED TO THE DEVICE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A FISTULAPLASTY TREATMENT PROCEDURE A BALLOON DETACHMENT OCCURRED. THE CUTTING BALLOON WAS BEING PREPPED FOR USE, AND WHEN THE USER WAS REMOVING THE PROTECTIVE BLUE SLEEVE FROM THE CUTTING BALLOON, THE BALLOON DETACHED FROM THE CATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A FISTULOPLASTY TREATMENT PROCEDURE, A BALLOON DETACHMENT OCCURRED. THE CUTTING BALLOON WAS BEING PREPPED FOR USE, AND WHEN THE USER WAS REMOVING THE PROTECTIVE BLUE SLEEVE FROM THE CUTTING BALLOON THE BALLOON DETACHED FROM THE CATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMALL PERIPHERAL CUTTING BALLOON CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY M001BPM4015140F0 13778677

    Patients

    Seq Age Sex Outcome Treatment
    1