BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE BALLOON DILATATION CATHETER

    MDR report key: 2122324 · Received June 13, 2011

    Report

    Report Number
    3005099803-2011-01966
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 18, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KNQ
    PMA / PMN Number
    K971320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS ORIGINALLY REPORTED THAT THE BALLOON BURST INSIDE THE PATIENT'S STOMACH, HOWEVER THIS WAS REPORTED IN ERROR. DURING THE PROCEDURE, THE BALLOON BURST IN THE PATIENT'S ESOPHAGUS.

    Additional Manufacturer Narrative · 1

    VISUAL EVALUATION OF THE RETURNED COMPLAINT DEVICE FOUND THE BALLOON PORTION OF THE DEVICE TO BE TORN LONGITUDINALLY; NO DEFECTS WERE NOTED TO THE CATHETER OF THE DEVICE. BASED ON THIS INFORMATION, THE COMPLAINT THAT THE BALLOON BURST WAS CONFIRMED. 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 DEVICE (E.G., THE BALLOON COMES IN CONTACT WITH A SHARP EXTERIOR SOURCE). A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Additional Manufacturer Narrative · 1

    PATIENT AGE, GENDER, AND WEIGHT ARE UNKNOWN. IT WAS REPORTED THE PATIENT WAS (B)(6). (B)(4). ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT YET BEEN COMPLETED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2011 THAT A CRE BALLOON DILATATION CATHETER WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2011 (PATIENT AGE, GENDER, AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON WAS INFLATED USING AN ALLIANCE II INFLATION HANDLE AND SYRINGE (BSC) AND BURST INSIDE THE PATIENT'S STOMACH. THE BALLOON WAS REMOVED AND THE PHYSICIAN DECIDED TO ABORT THE PROCEDURE. NO PIECES OF THE BALLOON DETACHED INSIDE THE PATIENT. IT WAS CONFIRMED THERE WAS NO MALFUNCTION OF THE ALLIANCE INFLATION HANDLE OR SYRINGE. 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 FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2011 THAT A CRE BALLOON DILATATION CATHETER WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6), 2011 (PATIENT AGE, GENDER, AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON WAS INFLATED USING AN ALLIANCE II INFLATION HANDLE AND SYRINGE (BSC) AND BURST INSIDE THE PATIENT'S STOMACH. THE BALLOON WAS REMOVED AND THE PHYSICIAN DECIDED TO ABORT THE PROCEDURE. NO PIECES OF THE BALLOON DETACHED INSIDE THE PATIENT. IT WAS CONFIRMED THERE WAS NO MALFUNCTION OF THE ALLIANCE INFLATION HANDLE OR SYRINGE. 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 FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2011 THAT A CRE BALLOON DILATATION CATHETER WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6), 2011 (PATIENT AGE, GENDER, AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON WAS INFLATED USING AN ALLIANCE II INFLATION HANDLE AND SYRINGE (BSC) AND BURST INSIDE THE PATIENT'S STOMACH. THE BALLOON WAS REMOVED AND THE PHYSICIAN DECIDED TO ABORT THE PROCEDURE. NO PIECES OF THE BALLOON DETACHED INSIDE THE PATIENT. IT WAS CONFIRMED THERE WAS NO MALFUNCTION OF THE ALLIANCE INFLATION HANDLE OR SYRINGE. 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 FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRE BALLOON DILATATION CATHETER DILATOR, ESOPHAGEAL KNQ BOSTON SCIENTIFIC - CORK M00558370 13793706

    Patients

    Seq Age Sex Outcome Treatment
    1 ALLIANCE INFLATION SYRINGE (BSC)| ALLIANCE II INFLATION HANDLE (BSC)