BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE BALLOON DILATATION CATHETER

    MDR report key: 1952483 · Received January 7, 2011

    Report

    Report Number
    3005099803-2010-05439
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 13, 2010
    Report Date
    December 15, 2010
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KNQ
    PMA / PMN Number
    K971320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): 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.

    Additional Manufacturer Narrative · 1

    VISUAL EVALUATION OF THE RETURNED COMPLAINT DEVICE REVEALED A KINK IN THE CATHETER. THE BALLOON PORTION OF THE DEVICE WAS FOUND TO BE TORN LONGITUDINALLY. THE CONDITION OF THE RETURNED INCIDENT DEVICE IS CONSISTENT WITH THE COMPLAINT THAT THE BALLOON BURST. THE MOST PROBABLE ROOT CAUSE FOR THIS EVENT IS OPERATIONAL CONTEXT; THIS FAILURE OCCURS WHEN PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE LIMIT THE PERFORMANCE OF THE BALLOON (E.G., THE BALLOON COMES INTO CONTACT WITH A SHARP EXTERIOR SOURCE). A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND CONFIRMED THAT NO NON CONFORMANCES WERE RAISED FOR THE SPECIFIED LOT. 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 ON (B)(6), 2010 THAT A CRE BALLOON DILATATION CATHETER AND ALLIANCE II INFLATION SYSTEM WERE USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON A (B)(6) PATIENT ON (B)(6), 2010 (PATIENT WEIGHT IS UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON WAS INFLATED TO 18MM IN THE ESOPHAGUS OF THE PATIENT USING THE ALLIANCE INFLATION SYSTEM. WHEN THE PHYSICIAN ATTEMPTED TO INFLATE THE BALLOON TO 20MM THE BALLOON BURST. THE BALLOON WAS SUCCESSFULLY REMOVED FROM THE PATIENT, AND IT WAS CONFIRMED THAT NO PIECES OF THE DEVICE DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE BALLOON DILATATION CATHETER AND THE SAME ALLIANCE II INFLATION SYSTEM. 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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2010 THAT A CRE BALLOON DILATATION CATHETER AND ALLIANCE II INFLATION SYSTEM WERE USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON A (B)(6) OLD FEMALE PATIENT ON (B)(6), 2010 (PATIENT WEIGHT IS UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON WAS INFLATED TO 18MM IN THE ESOPHAGUS OF THE PATIENT USING THE ALLIANCE INFLATION SYSTEM. WHEN THE PHYSICIAN ATTEMPTED TO INFLATE THE BALLOON TO 20MM THE BALLOON BURST. THE BALLOON WAS SUCCESSFULLY REMOVED FROM THE PATIENT, AND IT WAS CONFIRMED THAT NO PIECES OF THE DEVICE DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE BALLOON DILATATION CATHETER AND THE SAME ALLIANCE II INFLATION SYSTEM. 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 M00558380 13669653

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR ALLIANCE II INFLATION SYSTEM (BSC)