BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN ACHIEVER PYLORIC BALLOON DIL CATH

    MDR report key: 273148 · Received April 12, 2000

    Report

    Report Number
    6000048-2000-00017
    Event Type
    Death
    Date Received
    April 12, 2000
    Date of Event
    February 23, 2000
    Report Date
    April 12, 2000
    Manufacturer
    MICROVASIVE ENDOSCOPY A DIV OF BOSTON SCIENTIFIC CORP.
    Product Code
    KOG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, WHILE DILATING THE PYLORUS, THE PHYSICIAN PERFORATED THE DUODENAL BULB. THE PROCEDURE WAS ABORTED. THE PATIENT EXPIRED 3 WEEKS LATER DUE TO COMPLICATIONS. THE DEVICE WAS DESTROYED AT THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN ACHIEVER PYLORIC BALLOON DIL CATH * KOG MICROVASIVE ENDOSCOPY A DIV OF BOSTON SCIENTIFIC CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention