BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRE? WIREGUIDED

    MDR report key: 3242789 · Received July 23, 2013

    Report

    Report Number
    3005099803-2013-07483
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 24, 2013
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KOG
    PMA / PMN Number
    K110833
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4):THE CATHETER OF THE DEVICE WAS RETURNED FOR EVALUATION AND WAS FOUND TO BE CUT/DAMAGED WITH SOME BALLOON MATERIAL EVIDENT AT THE CUT/DAMAGED END. THE BALLOON PORTION WAS NOT RETURNED FOR ANALYSIS, HOWEVER A PICTURE OF THE BALLOON WAS RECEIVED AND THE BALLOON MATERIAL APPEARED TO BE TORN. THE EVENT MOST LIKELY OCCURRED DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE WHICH LIMITED PERFORMANCE OF THE DEVICE. THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THIS EVENT IS OPERATIONAL CONTEXT.THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE WG DILATATION BALLOON WAS USED DURING A DILATATION PROCEDURE IN THE DIGESTIVE CANAL PERFORMED ON (B)(6), 2013.ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON RUPTURED BEFORE REACHING 6ATM AND THE BALLOON DETACHED INSIDE THE PATIENT WHEN BEING REMOVED FROM THE SCOPE. THE DETACHED BALLOON WAS REMOVED FROM THE PATIENT USING GRASPING FORCEPS. IT WAS REPORTED THE LESION WAS IN AN ANASTOMOTIC PART OF THE ESOPHAGUS AND STAPLES HAD BEEN USED. IT WAS NOT VERIFIED WHETHER THERE WERE STAPLES NEAR THE BALLOON DURING INFLATION. THE PROCEDURE WAS NOT COMPLETED HOWEVER THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343458 CRE? WIREGUIDED ENDOSCOPE AND/OR ACCESSORIES, DILATOR, ESOPHAGEAL KOG BOSTON SCIENTIFIC - CORK M00558500 0013793770

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention