BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C.R.E. ESOPHAGEAL/PYLORIC WIREGUIDED BALLOON DILATATION CATHETER

    MDR report key: 1569625 · Received December 2, 2009

    Report

    Report Number
    3005099803-2009-05669
    Event Type
    Malfunction
    Date Received
    December 2, 2009
    Date of Event
    November 3, 2009
    Report Date
    November 3, 2009
    Manufacturer
    BOSTON SCIENTIFIC CORK, LTD.
    Product Code
    KNQ
    PMA / PMN Number
    K971320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE BALLOON WAS TORN LONGITUDINALLY AND THERE WAS NO DAMAGE TO THE CATHETER SHAFT. THE MOST PROBABLE ROOT CAUSE OF A BALLOON TORN LONGITUDINALLY IS OPERATIONAL CONTEXT. THIS FAILURE OCCURS WHEN ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE LIMITED THE PERFORMANCE OF THE BALLOON (E.G. TORTUOUS ANATOMY). A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED LOT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP THAT A C.R.E. ESOPHAGEAL/PYLORIC WIREGUIDED BALLOON DILATATION CATHETER WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY WITH DILATION OF THE ESOPHAGUS. THE PROCEDURE WAS PERFORMED (B)(6) 2009 ON A FEMALE PT. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE, THE BALLOON WAS POSITIONED WITHIN THE ESOPHAGUS TO TREAT A BENIGN STRICTURE. THE BALLOON WAS SUCCESSFULLY INFLATED WITH SALINE SOLUTION TO 13.5 MM. HOWEVER, WHEN THE PHYSICIAN FURTHER INFLATED THE BALLOON TO 15MM, THE BALLOON BURST. ANOTHER CRE BALLOON OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C.R.E. ESOPHAGEAL/PYLORIC WIREGUIDED BALLOON DILATATION CATHETER KNQ BOSTON SCIENTIFIC CORK, LTD. M00558360 0012842255

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALLIANCE HANDLE| SYRINGE