BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING BALLOON DILATATION CATHETER

    MDR report key: 2221165 · Received August 24, 2011

    Report

    Report Number
    2134265-2011-03475
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 1, 2011
    Product Code
    DQY
    PMA / PMN Number
    K053116
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER - IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. 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 ANGIOPLASTY, A BALLOON RUPTURE OCCURRED. THE 99% STENOSED LESION BEING TREATED WAS LOCATED IN THE SEVERELY TORTUOUS LEFT RADIAL VEIN. THE 5.0X20/40MM STERLING OTW BALLOON WAS ADVANCED AND THE PHYSICIAN NOTED A LIGHT RESISTANCE. THE BALLOON WAS INFLATED TO 8 ATMS FOR 60 SECONDS, A SECOND INFLATION OF 8 ATM FOR 60 SECONDS, AND A THIRD INFLATION AT 12 ATMS, THE BALLOON BURST ON THE THIRD INFLATION. THE DEVICE WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER 5.0X20/40MM STERLING OTW BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERLING BALLOON DILATATION CATHETER CATHETER, PERCUTANEOUS DQY H74939032502040 13445909

    Patients

    Seq Age Sex Outcome Treatment
    1 INFLATION DEVICE: ENCORE26| INTRODUCER SHEATH: MOSQUITO| GUIDE WIRE: TRANSEND 14