BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIGIFLEX II ACHALASIA DILATATION CATHETER

    MDR report key: 931645 · Received October 24, 2007

    Report

    Report Number
    6000122-2007-00025
    Event Type
    Injury
    Date Received
    October 24, 2007
    Date of Event
    August 23, 2007
    Report Date
    August 30, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORK, LTD
    Product Code
    KNQ
    PMA / PMN Number
    K781772
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE HAS BEEN DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION. A DEVICE ANALYSIS WILL NOT BE PERFORMED; THEREFORE, THE RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED EVENT IS UNK. REVIEWS OF THE DEVICE HISTORY RECORD AND THE PRODUCT FAMILY COMPLAINT TREND REPORT ARE IN PROGRESS; RESULTS WILL BE PROVIDED IN A FOLLOW-UP MEDWATCH REPORT.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO THE SECOND OF TWO DEVICES, USED IN CONJUNCTION, INVOLVED IN AN ADVERSE EVENT. SEE RELATED MEDWATCH REPORT #6000143-2007-00003. IN 2007, IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DILATATION TREATMENT OF AN ESOPHAGEAL ACHALASIA WAS PERFORMED USING A PNEUMATIC INFLATOR AND A RIGIFLEX II ACHALASIA BALLOON DILATATION CATHETER (PATIENT AGE, GENDER, AND WEIGHT UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE "MANOMETER [BECAME] STUCK AT 10 PSI....IT SEEMS THAT THE BALLOON WAS MORE INFLATED THAN 10 PS." IT WAS FURTHER REPORTED, "IN THE SAME TIME, A PNEUMOMEDIASTINUM APPEARED....ACCORDING TO THE PHYSICIAN THERE IS A LINK BETWEEN THE DILATATION [PROCEDURE] AND THE PNEUMOMEDIASTINUM, BUT HE CAN'T DETERMINE EXACTLY IF THERE IS A LINK BETWEEN THE MANOMETER FAILURE AND THIS PNEUMOMEDIASTINUM." THERE WAS NO REPORTED ISSUE EITHER DEFLATING THE BALLOON OR REMOVING THE DEVICE FROM THE PT. REPORTEDLY, FOLLOWING THE DILATATION PROCEDURE, THE PT WAS HAVING "PULMONARY RELAPSES." THERE WAS NO MEDICAL INTERVENTION PERFORMED; HOWEVER, THE PT "STAYED AT [THE] HOSPITAL 15 MORE DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIGIFLEX II ACHALASIA DILATATION CATHETER KNQ BOSTON SCIENTIFIC CORK, LTD M00554510 0000028432

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization