BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE BALLOON DILATATION CATHETER

    MDR report key: 2001434 · Received February 25, 2011

    Report

    Report Number
    3005099803-2011-00558
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    February 4, 2011
    Report Date
    February 4, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KNQ
    PMA / PMN Number
    K971320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6):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 THE BALLOON TO BE TORN LONGITUDINALLY. NO VISIBLE DEFECTS WERE NOTED TO THE CATHETER OF THE DEVICE. 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 SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO CRE BALLOON DILATATION CATHETERS USED IN THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2011-00558 ADDRESSES THE FIRST BALLOON, WHILE MANUFACTURER REPORT # 3005099803-2011-00559 ADDRESSES THE SECOND BALLOON. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2011 THAT TWO CRE BALLOON DILATATION CATHETERS WERE USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON A (B)(6) FEMALE PATIENT ON (B)(6), 2011 (PATIENT WEIGHT IS UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, BOTH BALLOONS WERE INFLATED TO A DIAMETER OF 18MM AND BURST INSIDE THE PATIENT. NO PIECES OF EITHER BALLOON DETACHED. AN ALLIANCE INFLATION HANDLE AND AN ALLIANCE INFLATION SYRINGE WERE USED TO INFLATE THE BALLOONS; IT WAS CONFIRMED THERE WAS NO MALFUNCTION OF EITHER INFLATION DEVICE. THE PROCEDURE WAS COMPLETED WITH THE SECOND CRE BALLOON DILATATION CATHETER. 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 CRE BALLOON DILATATION CATHETERS USED IN THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2011-00558 ADDRESSES THE FIRST BALLOON, WHILE MANUFACTURER REPORT # 3005099803-2011-00559 ADDRESSES THE SECOND BALLOON. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2011 THAT TWO CRE BALLOON DILATATION CATHETERS WERE USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON A (B)(6) FEMALE PATIENT ON (B)(6) 2011 (PATIENT WEIGHT IS UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, BOTH BALLOONS WERE INFLATED TO A DIAMETER OF 18MM AND BURST INSIDE THE PATIENT. NO PIECES OF EITHER BALLOON DETACHED. AN ALLIANCE INFLATION HANDLE AND AN ALLIANCE INFLATION SYRINGE WERE USED TO INFLATE THE BALLOONS; IT WAS CONFIRMED THERE WAS NO MALFUNCTION OF EITHER INFLATION DEVICE. THE PROCEDURE WAS COMPLETED WITH THE SECOND CRE BALLOON DILATATION CATHETER. 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 13972614

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR ALLIANCE INFLATION SYRINGE (BSC)| ALLIANCE INFLATION HANDLE (BSC)