BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR

    MDR report key: 1604797 · Received February 18, 2010

    Report

    Report Number
    3005099803-2010-00678
    Event Type
    Malfunction
    Date Received
    February 18, 2010
    Date of Event
    December 9, 2009
    Report Date
    January 25, 2010
    Manufacturer
    TECHDEVICE CORPORATION
    Product Code
    KNQ
    PMA / PMN Number
    K050232
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    RESTERILIZED: NO. USAGE OF DEVICE: INITIAL. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED THAT COULD BE RELATED TO THIS COMPLAINT. A REVIEW OF THE COMPLAINT HISTORY FOR LOT NUMBER 0000051601 WAS PERFORMED AND CONCLUDED THERE WERE NO OTHER COMPLAINTS REPORTED FOR THIS LOT. A SIMILAR COMPLAINTS REVIEW WAS PERFORMED AND FOUND NO ADVERSE TRENDS. AS THE SUSPECT DEVICE WAS NOT RETURNED FOR INVESTIGATION THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JANUARY 25, 2010 THAT AN ACHALASIA DILATATION BALLOON. WAS USED DURING AN ESOPHAGEAL DILATATION PROCEDURE ON (B)(6), 2009. ACCORDING TO THE COMPLAINANT, AFTER SUCCESSFUL DILATATION WITH THE BALLOON, THE BALLOON WAS CAUGHT IN THE ESOPHAGUS WHEN ATTEMPTING REMOVAL. ADDITIONAL INFORMATION RECEIVED REVEALED THE BALLOON WAS STUCK MID ESOPHAGUS. THE COMPLAINANT REPORTED NEGATIVE SUCTION WAS APPLIED AND WHEN AN ENDOSCOPE WAS PASSED THROUGH THE ESOPHAGUS IT WAS NOTED THERE WAS NOTHING CAUGHT ON THE BALLOON. THE BALLOON WAS ABLE TO BE REMOVED ALONGSIDE THE SCOPE BY USING SIDE TO SIDE MOTIONS. THE COMPLAINANT CONFIRMED THERE WAS NO VISIBLE DAMAGE TO THE DEVICE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE EVENT WAS REPORTED TO BE "STABLE".

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JANUARY 25, 2010 THAT AN ACHALASIA DILATATION BALLOON. WAS USED DURING AN ESOPHAGEAL DILATATION PROCEDURE ON (B)(6), 2009. ACCORDING TO THE COMPLAINANT, AFTER SUCCESSFUL DILATATION WITH THE BALLOON, THE BALLOON WAS CAUGHT IN THE ESOPHAGUS WHEN ATTEMPTING REMOVAL. ADDITIONAL INFORMATION RECEIVED REVEALED THE BALLOON WAS STUCK MID ESOPHAGUS. THE COMPLAINANT REPORTED NEGATIVE SUCTION WAS APPLIED AND WHEN AN ENDOSCOPE WAS PASSED THROUGH THE ESOPHAGUS IT WAS NOTED THERE WAS NOTHING CAUGHT ON THE BALLOON. THE BALLOON WAS ABLE TO BE REMOVED ALONGSIDE THE SCOPE BY USING SIDE TO SIDE MOTIONS. THE COMPLAINANT CONFIRMED THERE WAS NO VISIBLE DAMAGE TO THE DEVICE. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE EVENT WAS REPORTED TO BE "STABLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR DILATOR, ESOPHAGEAL KNQ TECHDEVICE CORPORATION M00554520 0000051601

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR