BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE? WIREGUIDED

    MDR report key: 3083250 · Received April 29, 2013

    Report

    Report Number
    3005099803-2013-03086
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 4, 2013
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KOG
    PMA / PMN Number
    K110833
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: VISUAL EVALUATION OF THE COMPLAINT DEVICE FOUND THE LUMEN INSIDE THE BALLOON TO BE BENT SUCH THAT THE BALLOON APPEARED TO BE AN IRREGULAR SHAPE. THE BALLOON WAS VISUALLY EXAMINED FOR ANY OTHER DEFECTS AND NONE WERE FOUND. FUNCTIONAL TESTING OF THE DEVICE COULD NOT BE PERFORMED AS THE BALLOON CATHETER WAS CUT. THE REPORTED FAILURE LIKELY OCCURRED DUE TO ANATOMICAL/PROCEDURAL FACTORS WHICH LIMITED THE PERFORMANCE OF THE DEVICE. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE LOT NUMBER. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT EXPIRED. REPORTED EVENT OF BALLOON INFLATES IN AN IRREGULAR SHAPE. ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2013 THAT CRE BALLOON DILATATION CATHETER WAS USED DURING A BALLOON INFLATION PROCEDURE IN THE ESOPHAGUS ON (B)(6) 2013. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE, THE BALLOON WAS INFLATED; HOWEVER THE SHAPE OF THE BALLOON APPEARED TO BE "DOGLEG." THE DEVICE WAS REMOVED WITH THE ENDOSCOPE AND THE CATHETER WAS CUT TO REMOVE THE DEVICE FROM THE ENDOSCOPE. THE PATIENT WAS RE-SCOPED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE EVENT. THE PATIENT¿S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2013 THAT CRE BALLOON DILATATION CATHETER WAS USED DURING A BALLOON INFLATION PROCEDURE IN THE ESOPHAGUS ON (B)(6) 2013. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE, THE BALLOON WAS INFLATED; HOWEVER THE SHAPE OF THE BALLOON APPEARED TO BE "DOGLEG." THE DEVICE WAS REMOVED WITH THE ENDOSCOPE AND THE CATHETER WAS CUT TO REMOVE THE DEVICE FROM THE ENDOSCOPE. THE PATIENT WAS RE-SCOPED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE 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
    185822 CRE? WIREGUIDED ENDOSCOPE AND/OR ACCESSORIES, DILATOR, ESOPHAGEAL KOG BOSTON SCIENTIFIC - CORK M00558440

    Patients

    Seq Age Sex Outcome Treatment
    1