BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C.R.E. BALLOON DILATION CATHETER

    MDR report key: 1122784 · Received June 9, 2008

    Report

    Report Number
    3005099803-2008-00660
    Event Type
    Malfunction
    Date Received
    June 9, 2008
    Date of Event
    May 9, 2008
    Report Date
    May 14, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    KNG
    PMA / PMN Number
    K971320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DESCRIPTION COULD NOT BE CONFIRMED AS THE COMPLAINT SAMPLE WAS NOT RETURNED. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER HAS BEEN REVIEWED FOR MANUFACTURING ISSUES AND NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD RELATE TO THIS COMPLAINT. THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE WILL BE CLASSIFIED AS UNDETERMINABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ESOPHAGEAL BALLOON DILATION TREATMENT PROCEDURE, THE BALLOON DEFLATION FAILED. A CRE 18-20MM 8CM F/G BALLOON DILATION CATHETER HAD BEEN SELECTED TO TREAT AN UNSPECIFIED ESOPHAGEAL LESION. WHILE THE PHYSICIAN WAS ATTEMPTING TO ADVANCE THE DEVICE, THE DEVICE KINKED AND WOULD NOT PASS THROUGH THE SCOPE ADEQUATELY. A SECOND CRE 18-20MM 8CM F/G BALLOON DILATION CATHETER WAS ADVANCED AND INFLATED, BUT WOULD NOT DEFLATE. THE DEVICE WAS ABLE "TO BE PULLED OUT WITH THE SCOPE AND CUT". THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE 18-20MM 8CM F/G BALLOON DILATION CATHETER. THERE WAS NO PT COMPLICATIONS REPORTED WITH THE PT'S CURRENT CONDITION LISTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C.R.E. BALLOON DILATION CATHETER KNG DILATOR, ESOPHAGEAL KNG BOSTON SCIENTIFIC 9762664

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR