BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMERGE¿

    MDR report key: 2771900 · Received October 4, 2012

    Report

    Report Number
    2134265-2012-06444
    Event Type
    Injury
    Date Received
    October 4, 2012
    Date of Event
    July 30, 2012
    Report Date
    September 5, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    K113220
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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

    (B)(4). SAME CASE AS: 2134265-2012-05952. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, AN INACCURATE GAUGE READING OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PHYSICIAN ADVANCED A 2.5 X 30MM EMERGE BALLOON CATHETER OVER A 182CM LUGE GUIDE WIRE TO THE LESION. AN ADVANTAGE 26 INFLATION DEVICE WAS CONNECTED TO THE BALLOON CATHETER AND ATTEMPTED TO INFLATE THE BALLOON, BUT THE DIAL ON THE GAUGE STAYED AT 0ATM. DURING FLURO A PERFORATION TO THE CORONARY WAS NOTED JUST DISTAL TO THE STENT. THE BALLOON HAD BEEN INFLATING WITHOUT THE DIAL REGISTERING. IT WAS NOTED THAT THE BALLOON AND GUIDE WIRE IN USE AT THE TIME OF THE EVENT ARE NOT BELIEVED TO HAVE CONTRIBUTED TO THE EVENT. NO FURTHER PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS IS OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMERGE¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE UNK731

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R ADVANTAGE 26 INFLATION DEVICE| 182CM LUGE GUIDEWIRE