BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE BALLOON DILATATION CATHETER

    MDR report key: 2082755 · Received May 10, 2011

    Report

    Report Number
    3005099803-2011-01636
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 14, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KNQ
    PMA / PMN Number
    K971320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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

    INVESTIGATION RESULTS: VISUAL EVALUATION OF THE RETURNED COMPLAINT DEVICE FOUND THE CATHETER TO HAVE TWO FRACTURES NEAR THE DISTAL END AND A KINK NEAR THE HUB. THE DISTAL END OF THE BALLOON TOGETHER WITH THE TIP WAS MISSING AS THE CATHETER WAS CUT AT THIS POINT. THE INVESTIGATION RESULTS ARE CONSISTENT WITH THE EVENT DESCRIPTION, HOWEVER THE INVESTIGATION RESULTS COULD NOT CONFIRM DIFFICULTY REMOVING NOR BALLOON DEFLATION FAILED AS FUNCTIONAL TEST FOR CATHETER PASSAGE THROUGH ENDOSCOPE COULD NOT BE PERFORMED AS THE BALLOON WAS NO LONGER IN ITS WING-FOLDED CONFIGURATION AND THE CATHETER WAS FRACTURED. THE REPORTED DEFECTS OF BALLOON TORN AND BALLOON DETACHED COULD BE CONFIRMED AS THE DISTAL PART OF BALLOON MISSING. THE ROOT CAUSED OF THIS COMPLAINT IS OPERATIONAL CONTEXT AS DUE TO ANATOMICAL/PROCEDURAL FACTORS PERFORMANCE OF THE DEVICE WAS LIMITED. 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 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), 2011 THAT A CRE FIXED WIRE BALLOON DILATATION CATHETER WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE IN THE ESOPHAGUS PREFORMED ON A (B)(6) OLD MALE PATIENT (PATIENT WEIGHT IS UNKNOWN). ACCORDING TO THE COMPLAINT, AFTER THE DILATATION PROCEDURE, THE BALLOON WAS DEFLATED TO BE REMOVED FROM THE SCOPE. AS THE BALLOON WAS BEING PULLED THROUGH THE SCOPE, IT CAUGHT ON THE END AND WAS UNABLE TO BE REMOVED. AS THE TECHNICIAN TRIED TO PULL IT OUT, THE BALLOON TORE AND FOLDED OVER ON ITSELF. IT COULD NOT BE CONFIRMED WHETHER OR NOT THE BALLOON COULD BE DEFLATED PRIOR TO WITHDRAWAL. THE DEVICE AND SCOPE WAS PULLED OUT OF THE PATIENT'S ANATOMY AND THE BALLOON WAS CUT OUT OF THE SCOPE. NO PIECES DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO HAVE NO COMPLICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2011 THAT A CRE FIXED WIRE BALLOON DILATATION CATHETER WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE IN THE ESOPHAGUS PREFORMED ON A (B)(6) OLD MALE PATIENT (PATIENT WEIGHT IS UNKNOWN). ACCORDING TO THE COMPLAINT, AFTER THE DILATATION PROCEDURE, THE BALLOON WAS DEFLATED TO BE REMOVED FROM THE SCOPE. AS THE BALLOON WAS BEING PULLED THROUGH THE SCOPE, IT CAUGHT ON THE END AND WAS UNABLE TO BE REMOVED. AS THE TECHNICIAN TRIED TO PULL IT OUT, THE BALLOON TORE AND FOLDED OVER ON ITSELF. IT COULD NOT BE CONFIRMED WHETHER OR NOT THE BALLOON COULD BE DEFLATED PRIOR TO WITHDRAWAL. THE DEVICE AND SCOPE WAS PULLED OUT OF THE PATIENT¿S ANATOMY AND THE BALLOON WAS CUT OUT OF THE SCOPE. NO PIECES DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE EVENT. THE PATIENT¿S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO HAVE NO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRE BALLOON DILATATION CATHETER DILATOR, ESOPHAGEAL KNQ BOSTON SCIENTIFIC - CORK M00558380 13883517

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR