BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE¿ WIREGUIDED

    MDR report key: 2241747 · Received September 9, 2011

    Report

    Report Number
    3005099803-2011-03144
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 19, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KOG
    PMA / PMN Number
    K974788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE, GENDER, AND WEIGHT ARE UNKNOWN. HOWEVER, IT WAS REPORTED THE PATIENT IS OVER 18 YEARS. VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND NO DAMAGE TO THE CATHETER OF THE DEVICE. HOWEVER, THROUGH FUNCTIONAL TESTING IT WAS REVEALED THAT A PINHOLE WAS PRESENT IN THE BALLOON MATERIAL. THE INVESTIGATION RESULTS ARE CONSISTENT WITH THE EVENT DESCRIPTION. THE REPORTED DEFECT OF BALLOON PINHOLE WAS CONFIRMED. THIS FAILURE LIKELY OCCURRED DUE TO ANATOMICAL/PROCEDURAL FACTORS WHICH LIMITED THE PERFORMANCE OF THE BALLOON. 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 SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Additional Manufacturer Narrative · 1

    CORRECTED INVESTIGATION RESULTS: VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND NO DAMAGE TO THE CATHETER OF THE DEVICE. HOWEVER, THROUGH FUNCTIONAL TESTING IT WAS REVEALED THAT A PINHOLE WAS PRESENT IN THE BALLOON MATERIAL. THE INVESTIGATION RESULTS ARE CONSISTENT WITH THE EVENT DESCRIPTION. THE REPORTED DEFECT OF BALLOON PINHOLE WAS CONFIRMED. THIS FAILURE LIKELY OCCURRED DUE TO ANATOMICAL/PROCEDURAL FACTORS WHICH LIMITED THE PERFORMANCE OF THE BALLOON. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. 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 BALLOON DILATATION CATHETER WAS USED DURING ESOPHAGUS INFLATION PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINT, IT WAS NOTED THAT WHEN 2 ATMS OF PRESSURE WAS APPLIED TO THE BALLOON IT WOULD NOT INFLATE. THEY CONFIRMED THAT THE BALLOON DID NOT BURST, HOWEVER A PINHOLE WAS NOTED TO THE BALLOON MATERIAL. 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 THAT A CRE BALLOON DILATATION CATHETER WAS USED DURING ESOPHAGUS INFLATION PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINT, IT WAS NOTED THAT WHEN 2 ATMS OF PRESSURE WAS APPLIED TO THE BALLOON IT WOULD NOT INFLATE. THEY CONFIRMED THAT THE BALLOON DID NOT BURST, HOWEVER A PINHOLE WAS NOTED TO THE BALLOON MATERIAL. 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
    1 CRE¿ WIREGUIDED ENDOSCOPE AND/OR ACCESSORIES, DILATOR, ESOPHAGEAL KOG BOSTON SCIENTIFIC - CORK M00558420 14157470

    Patients

    Seq Age Sex Outcome Treatment
    1