BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIGIFLEX II ACHALASIA BALLOON DILATOR

    MDR report key: 1080766 · Received July 23, 2008

    Report

    Report Number
    3005099803-2008-01256
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    June 5, 2008
    Report Date
    June 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNQ
    PMA / PMN Number
    K050232
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS UNK; THEREFORE, THE MANUFACTURE DATE CANNOT BE DETERMINED. THE COMPLAINANT HAS INDICATED THAT THE DEVICE WAS DISPOSED, AND NOT AVAILABLE FOR RETURN. THEREFORE, A DEVICE EVAL CANNOT BE PERFORMED. THE CAUSE FOR THE REPORTED EVENT IS UNDETERMINED. A SEARCH OF THE CUSTOMER SHIPMENT HISTORY IDENTIFIED THREE LOTS SHIPPED TO THE CUSTOMER PRIOR TO THE EVENT DATE (LOTS: 0000034880, 0000033470, 0000031330). THE DEVICE HISTORY RECORD FOR EACH OF THE THREE LOTS WAS REVIEWED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED NO ADDITIONAL COMPLAINTS REPORTED FOR ANY OF THE THREE LOTS. THE MAY 2008 15-MONTH ACHALASIA BALLOON PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP ON JUNE 24, 2008, THAT A REGIFLEX II SINGLE USE ACHALASIA BALLOON DILATOR DEVICE WAS USED IN 2008. ACCORDING TO THE COMPLAINANT, "DURING THE PROCEDURE, THE DEVICE WAS SUCCESSFULLY INFLATED WITH AIR AT 12 PSI FOR 2 MINUTES. WHEN ENTERED INTO THE LESION, SUDDENLY NO RESISTANCE WAS FELT AND DEVICE WAS REMOVED. THE LESION WAS VIEWED WITH A SCOPE AND A LONGITUDINAL TEAR WAS NOTED IN THE ESOPHAGUS. CLIPPING WAS PERFORMED TO TREAT THE PERFORATION SUCCESSFULLY. THE PHYSICIAN DOES NOT RECOGNIZE THIS EVENT AS BEING RELATED TO THE PRODUCT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIGIFLEX II ACHALASIA BALLOON DILATOR KNQ BOSTON SCIENTIFIC CORPORATION M00554510 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention