BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE BALLOON DILATATION CATHETER

    MDR report key: 1880683 · Received October 25, 2010

    Report

    Report Number
    3005099803-2010-04501
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    September 24, 2010
    Report Date
    September 29, 2010
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KNQ
    PMA / PMN Number
    K971320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 NO PREVIOUS COMPLAINTS FOR THE SPECIFIED LOT. INFLATION OF THE RETURNED COMPLAINT DEVICE WAS ATTEMPTED; HOWEVER, A LONGITUDINAL TEAR WAS FOUND IN THE BALLOON. VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THERE WAS NO DAMAGE TO THE CATHETER OF THE DEVICE. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE BALLOON BURST. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT; THIS FAILURE OCCURS WHEN PROCEDURAL FACTORS ENCOUNTERED LIMIT THE PERFORMANCE OF THE BALLOON (E.G., THE BALLOON COMES INTO CONTACT WITH SHARP EXTERIOR SOURCES).

    Additional Manufacturer Narrative · 1

    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

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO COMPLAINT DEVICES USED IN THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2010-04501 ADDRESSES THE CRE BALLOON DILATATION CATHETER, WHILE MANUFACTURER REPORT #3005099803-2010-04544 ADDRESSES THE ALLIANCE INFLATION SYRINGE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE BALLOON DILATATION CATHETER AND ALLIANCE INFLATION SYSTEM WERE USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH DILATATION PROCEDURE PERFORMED ON A 64 YEAR-OLD MALE PATIENT ON (B)(6), 2010 (PATIENT WEIGHT IS UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON WAS INFLATED WITHIN THE ESOPHAGUS. AT A PRESSURE OF 7PSI AND DIAMETER OF 18MM, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE BALLOON DILATATION CATHETER, AND THE SAME ALLIANCE HANDLE. IT IS UNKNOWN WHETHER THE SAME ALLIANCE INFLATION SYRINGE WAS USED TO COMPLETE THE PROCEDURE; THEREFORE, IT CANNOT BE CONFIRMED WHETHER THE GAUGE OF THE SYRINGE WAS READING ACCURATELY WHEN THE BALLOON BURST. 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 FINE.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO COMPLAINT DEVICES USED IN THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2010-04501 ADDRESSES THE CRE BALLOON DILATATION CATHETER, WHILE MANUFACTURER REPORT #3005099803-2010-04544 ADDRESSES THE ALLIANCE INFLATION SYRINGE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE BALLOON DILATATION CATHETER AND ALLIANCE INFLATION SYSTEM WERE USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH DILATATION PROCEDURE PERFORMED ON A (B)(6) MALE PATIENT ON (B)(6), 2010 (PATIENT WEIGHT IS UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON WAS INFLATED WITHIN THE ESOPHAGUS. AT A PRESSURE OF 7PSI AND DIAMETER OF 18MM, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE BALLOON DILATATION CATHETER, AND THE SAME ALLIANCE HANDLE. IT IS UNKNOWN WHETHER THE SAME ALLIANCE INFLATION SYRINGE WAS USED TO COMPLETE THE PROCEDURE; THEREFORE, IT CANNOT BE CONFIRMED WHETHER THE GAUGE OF THE SYRINGE WAS READING ACCURATELY WHEN THE BALLOON BURST. 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 FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRE BALLOON DILATATION CATHETER DILATOR, ESOPHAGEAL KNQ BOSTON SCIENTIFIC - CORK M00558370 12982921

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR ALLIANCE II INFLATION HANDLE (BSC)