BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRE FIXED WIRE BALLOON DILATOR

    MDR report key: 904247 · Received August 29, 2007

    Report

    Report Number
    6000122-2007-00020
    Event Type
    Injury
    Date Received
    August 29, 2007
    Date of Event
    July 27, 2007
    Report Date
    July 31, 2007
    Manufacturer
    BOSTON SCIENTIFIC COKE LTD
    Product Code
    KNQ
    PMA / PMN Number
    K971320
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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. SINCE A LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER, A REVIEW OF THE CUSTOMER'S SHIPMENT HISTORY IDENTIFIED ONLY ONE LOT (9091725) OF UPN SHIPPED OVER A 30 MONTH PERIOD (JANUARY 1, 2005 TO JULY 31, 2007). THE DEVICE HISTORY RECORD FOR THIS LOT WAS REVIEWED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO ADDITIONAL COMPLAINTS HAVE BEEN REPORTED FOR THIS SAME LOT. THE JULY 15-MONTH CRE BALLOON FIXED WIRE PRODUCT FAMILY COMPLAINT TREND REPORT WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED.

    Description of Event or Problem · 1

    IN 2007, IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE USING A CRE FIXED WIRE BALLOON DILATOR WAS PERFORMED (FEMALE PT). ACCORDING TO THE COMPLAINANT, AFTER THE EGD PROCEDURE, THE PT EXPERIENCED DISCOMFORT. THE PT WAS EXAMINED AND THE PHYSICIAN NOTED A "PERFORATION IN THE ESOPHAGUS." THE PT WAS THEN HOSPITALIZED AND WAS TREATED WITH "BROAD-SPECTRUM IV ANTIBIOTICS AND MADE NPO." THE CUSTOMER STATED THAT THE PT HAS REMAINED "AFEBRILE... IS PAIN FREE... AND HAS NO SIGNS OF INFECTION." REPORTEDLY, THE PT WILL RETURN TO A "SKILLED NURSING FACILITY AND [WILL] HAVE A REPEAT CONTRAST STUDY DONE IN ONE TO TWO WEEKS." THE PHYSICIAN EXPECTS THE PERFORATION TO "HEAL SPONTANEOUSLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRE FIXED WIRE BALLOON DILATOR KNQ BOSTON SCIENTIFIC COKE LTD M00558370 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R