BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERLING¿

    MDR report key: 2801996 · Received October 23, 2012

    Report

    Report Number
    2134265-2012-06391
    Event Type
    Injury
    Date Received
    October 23, 2012
    Date of Event
    September 26, 2012
    Report Date
    September 25, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K053118
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).DEVICE EVALUATED BY MANUFACTURER - THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL INTERVENTION, A SHAFT BREAK OCCURRED AND THE PATIENT UNDERWENT SURGERY. RADIAL ACCESS WAS OBTAINED TO TREAT A FISTULA IN THE ARM. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED DIFFICULTIES ADVANCING THE 6.0X20/135MM STERLING BALLOON TO THE MODERATELY CALCIFIED LESION. THE BALLOON WAS NOT INFLATED DUE TO DIFFICULTIES EXPERIENCED THROUGH THE ADVANCEMENT OF THE DEVICE. IN AN ATTEMPT TO REMOVE THE DEVICE, A SHAFT BREAK OCCURRED. THE BALLOON AND SEVERAL INCHES OF THE CATHETER REMAINED IN THE PATIENT. THE PATIENT WAS SENT TO SURGERY FOR THE BALLOON PORTION AND SEVERAL INCHES OF THE CATHETER THAT REMAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERLING¿ CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H74939031602010 15416181

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention