BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE BALLOON DILATATION CATHETER

    MDR report key: 3073360 · Received April 23, 2013

    Report

    Report Number
    3005099803-2013-02742
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Report Date
    March 29, 2013
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KNQ
    PMA / PMN Number
    K971320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THE PATIENT WAS OVER 18 YEARS OLD. THE EXACT DATE OF THE EVENT/PROCEDURE IS UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE EVENT TOOK PLACE SOME TIME BETWEEN THE (B)(6) 2013. THE COMPLAINANT WAS UNABLE TO PROVIDE THE DEVICE MODEL, CATALOG NUMBER OR LOT NUMBER. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. IT WAS REPORTED THE DEVICE WAS NOT USED PAST ITS EXPIRY DATE. (B)(4) FOR THE REPORTED EVENT OF BALLOON DEFLATION DIFFICULTY. ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2013 THAT A CRE BALLOON DILATATION CATHETER WAS USED DURING A ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH DILATATION PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN WAS DEFLATING THE BALLOON IN THE ESOPHAGUS, THE BALLOON DEFLATED SLOWER THAN NORMAL. THE DEVICE WAS WITHDRAWN BEFORE ALL OF THE INFLATION MEDIA WAS REMOVED FROM THE BALLOON AND THE BALLOON BUNCHED UP WHEN WITHDRAWN INTO THE SCOPE. THE BALLOON WAS REMOVED TOGETHER WITH THE SCOPE. THE PROCEDURE HAD ALREADY BEEN COMPLETED WITH THIS CRE BALLOON DILATATION CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE CONDITION OF THE PATIENT AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174774 CRE BALLOON DILATATION CATHETER DILATOR, ESOPHAGEAL KNQ BOSTON SCIENTIFIC - CORK UNK100

    Patients

    Seq Age Sex Outcome Treatment
    1