BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACHALASIA BALLOON DILATATION CATHETER

    MDR report key: 38740 · Received September 16, 1996

    Report

    Report Number
    1220563-1996-00001
    Event Type
    Injury
    Date Received
    September 16, 1996
    Date of Event
    August 5, 1996
    Report Date
    August 21, 1996
    Manufacturer
    MICROVASIVE ENDOSCOPY
    Product Code
    KNQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS DIAGNOSED WITH AN ESOPHAGEAL PERFORATION TWO HOURS AFTER UNDERGOING AN ACHALASIA PROCEDURE. AN X-RAY REVEALED AN ESOPHAGEAL PERFORATION AFTER THE PT EXPERIENCED CHEST PAIN TWO HOURS POST DILATION PROCEDURE. SURGICAL REPAIR OF THE ESOPHAGUS WAS UNEVENTFUL. THE PT'S CONDITION IS GOOD AND HAS SINCE BEEN DISCHARGED. THIS PRODUCT IS A REUSABLE DEVICE. RESTERILIZATION PROCESSES ARE RECOMMENDED IN CO'S DIRECTIONS FOR USE. THE NUMBER OF TIMES AND FREQUENCY THIS PRODUCT IS USED, AS WELL AS THE ACTUAL STERILIZATION PROCESS USED, IS AT THE DISCRETION OF THE USER. FOLLOW UP INDICATED THE PT'S CONDITION, RATHER THAN THE DEVICE, WAS A CONTRIBUTING FACTOR TO THIS EVENT. DUE TO THE NATURE OF THE LESION, A PEDIATRIC SCOPE WAS REQUIRED FOR CROSSING OF THE LESION IN THIS ADULT PT. INFO REGARDING BALLOON RUPTURE IS INCONCLUSIVE AT THIS TIME. CO BELIEVES THE ABOVE FACTORS CONTRIBUTED TO THIS EVENT AND DOES NOT ATTRIBUTE IT TO THE DEVICE. HOWEVER, WITHOUT EVALUATING THE DEVICE, CO CANNOT DETERMINE THE EXACT CAUSE FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACHALASIA BALLOON DILATATION CATHETER REUSE GL BAL DIL CATH KNQ MICROVASIVE ENDOSCOPY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| R