BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTAGE BALLOON CATHETER INFLATION DEVICE

    MDR report key: 2810212 · Received October 31, 2012

    Report

    Report Number
    2134265-2012-06609
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    October 2, 2012
    Report Date
    October 3, 2012
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MAV
    PMA / PMN Number
    K955869
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).DEVICE EVALUATED BY MFR.: 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 AN UNSPECIFIED TREATMENT PROCEDURE, A NON BSC PRESSURE WIRE WAS DAMAGED AND REMOVAL DIFFICULTIES WERE ENCOUNTERED. A NON BSC PRESSURE WIRE WAS "PRE-SHAPED" AND DAMAGED WHILE ATTEMPTING TO INTRODUCE THE WIRE THROUGH THE INSERTION TOOL. A SECOND NON BSC WIRE WAS "PRE-SHAPED" AND THEN WAS ADVANCED THROUGH THE INSERTION TOOL WITH RESISTANCE. THE DISTAL SHAPE OF THE NON BSC PRESSURE WIRE WAS CHANGED AND THE WIRE WAS DAMAGED. THIS WIRE WAS USED AND BECAME STUCK IN THE WALL OF THE RIGHT CORONARY ARTERY. AN UNSPECIFIED COMPLIANT BALLOON WAS USED TO FREE THE WIRE AND THE BALLOON AND WIRE WERE REMOVED AS A UNIT INTACT. ANOTHER PRESSURE WIRE WAS USED, BUT NOT "PRE SHAPED" AND THE PROCEDURE WAS COMPLETED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANTAGE BALLOON CATHETER INFLATION DEVICE SYRINGE, BALLOON INFLATION MAV BOSTON SCIENTIFIC - CORK H74904527011

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ST. JUDE PRESSURE WIRE