BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING BALLOON DILATATION CATHETER

    MDR report key: 2120572 · Received June 10, 2011

    Report

    Report Number
    2134265-2011-02272
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    April 16, 2011
    Report Date
    May 19, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K053116
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: RETURNED PRODUCT CONSISTED OF AN STERLING BALLOON CATHETER WITH NO BLOOD AND CONTRAST VISIBLE. THE BALLOON WAS LOOSELY FOLDED. THERE WAS A CIRCUMFERENTIAL TEAR FROM THE PROXIMAL EDGE OF THE DISTAL MARKER. INSPECTION OF THE BALLOON PRESENTED NO IRREGULARITIES IN THE BALLOON MATERIAL OR THE RO MARKERS THAT COULD HAVE CONTRIBUTED TO THE DAMAGE. THERE WAS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. . THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2011. IT WAS REPORTED THAT DURING PREPARATION FOR AN ANGIOPLASTY TREATMENT PROCEDURE, THE BALLOON DID NOT INFLATE. WHILE PREPARING THE 10MM X 40MM X 80CM STERLING BALOON, IT WAS NOTED THAT THE BALLOON DID NOT INFLATE AFTER SEVERAL TRIALS. THE PROCEDURE WAS COMPLETED WITH ANOTHER STERLING BALLOON AND THE PATIENT'S STATUS IS STABLE. HOWEVER DEVICE ANALYSIS REVEALED A CIRCUMFERENTIAL TEAR IN THE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERLING BALLOON DILATATION CATHETER CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H74939032104080 12180807

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR