BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE BALLOON DILATATION CATHETER

    MDR report key: 1935418 · Received December 22, 2010

    Report

    Report Number
    3005099803-2010-05262
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 1, 2010
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KNQ
    PMA / PMN Number
    K971320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 EXAMINATION OF THE RETURNED COMPLAINT DEVICE REVEALED NO DEFECTS TO THE CATHETER OF THE DEVICE; 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. IT IS POSSIBLE THE BALLOON WAS OVER INFLATED AS THE GAUGE WAS REPORTED TO BE READING INACCURATELY, OR THE BALLOON CAME INTO CONTACT WITH A SHARP EXTERIOR SOURCE. THEREFORE, 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. 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 FOUR COMPLAINT DEVICES USED IN THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2010-05262 ADDRESSES THE FIRST CRE BALLOON, MANUFACTURER REPORT # 3005099803-2010-05263 ADDRESSES THE SECOND CRE BALLOON, MANUFACTURER REPORT # 3005099803-2010-05264 ADDRESSES THE THIRD CRE BALLOON, AND MANUFACTURER REPORT # 3005099803-2010-05265 ADDRESSES THE ALLIANCE INFLATION SYRINGE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2010 THAT THREE CRE BALLOON DILATATION CATHETERS, AN ALLIANCE INFLATION SYRINGE, AND AN ALLIANCE II INFLATION HANDLE WERE USED DURING AN ESOPHAGEAL ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON A (B)(6) YEAR-OLD MALE PATIENT ON (B)(6), 2010 (PATIENT WEIGHT IS UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, EACH BALLOON POPPED AFTER APPROXIMATELY HALF OF THE WATER IN THE SYRINGE WAS USED TO INFLATE. IT WAS CONFIRMED THE GAUGE OF THE ALLIANCE INFLATION SYRINGE WAS READING INACCURATELY; THE NEEDLE DID NOT MOVE AS THE BALLOONS WERE BEING INFLATED. THE ACCOUNT ALSO REPORTED IT WAS DIFFICULT TO MAINTAIN PRESSURE ON THE ALLIANCE SYRINGE USING THE ALLIANCE INFLATION HANDLE; HOWEVER, THERE WERE NO VISIBLE ISSUES NOTED TO THE HANDLE AND IT WAS USED WITH THE SAME SYRINGE AND THE THIRD BALLOON TO COMPLETE THE PROCEDURE. 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 FOUR COMPLAINT DEVICES USED IN THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2010-05262 ADDRESSES THE FIRST CRE BALLOON, MANUFACTURER REPORT # 3005099803-2010-05263 ADDRESSES THE SECOND CRE BALLOON, MANUFACTURER REPORT # 3005099803-2010-05264 ADDRESSES THE THIRD CRE BALLOON, AND MANUFACTURER REPORT # 3005099803-2010-05265 ADDRESSES THE ALLIANCE INFLATION SYRINGE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2010, THAT THREE CRE BALLOON DILATATION CATHETERS, AN ALLIANCE INFLATION SYRINGE, AND AN ALLIANCE II INFLATION HANDLE WERE USED DURING AN ESOPHAGEAL ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON A (B)(6) MALE PATIENT ON (B)(6) 2010, (PATIENT WEIGHT IS UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, EACH BALLOON POPPED AFTER APPROXIMATELY HALF OF THE WATER IN THE SYRINGE WAS USED TO INFLATE. IT WAS CONFIRMED THE GAUGE OF THE ALLIANCE INFLATION SYRINGE WAS READING INACCURATELY; THE NEEDLE DID NOT MOVE AS THE BALLOONS WERE BEING INFLATED. THE ACCOUNT ALSO REPORTED IT WAS DIFFICULT TO MAINTAIN PRESSURE ON THE ALLIANCE SYRINGE USING THE ALLIANCE INFLATION HANDLE; HOWEVER, THERE WERE NO VISIBLE ISSUES NOTED TO THE HANDLE AND IT WAS USED WITH THE SAME SYRINGE AND THE THIRD BALLOON TO COMPLETE THE PROCEDURE. 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 M00558340 13481168

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR ALLIANCE II INFLATION HANDLE (BSC)