BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE(TM) BALLOON DILATATION CATHETER

    MDR report key: 1920252 · Received December 10, 2010

    Report

    Report Number
    3005099803-2010-05105
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 19, 2010
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KOG
    PMA / PMN Number
    K974788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED INCIDENT DEVICE PRESENTED WITH THE BALLOON RELAXED AND DEFLATED, THEREFORE THE DEVICE COULD NOT BE INSERTED INTO THE ENDOSCOPE. VISUAL EVALUATION REVEALED NO DAMAGE TO THE CATHETER OF THE DEVICE, HOWEVER THE BLACK EXIT MARKER ON THE CATHETER WAS FOUND TO BE ACCORDIONED; THEREFORE THIS COMPLAINT REMAINS AN MDR REPORTABLE EVENT. BASED ON THE CONDITION OF THE RETURNED INCIDENT DEVICE, THE COMPLAINT THAT THE CATHETER WAS BROKEN WAS NOT CONFIRMED; HOWEVER, THE DAMAGE NOTED TO THE EXIT MARKER IS CONSISTENT WITH THE REPORTED EVENT THAT IT WAS DIFFICULT TO REMOVE THE DEVICE FROM THE ENDOSCOPE. BASED ON THIS INFORMATION, 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.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2010 THAT A CRE BALLOON DILATATION CATHETER WAS USED DURING A COLONOSCOPY STRICTURE DILATION PROCEDURE PERFORMED ON A 55 YEAR-OLD MALE PATIENT ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON WOULD NOT EXIT THE WORKING CHANNEL OF THE ENDOSCOPE. THE BALLOON WAS REMOVED FROM THE ENDOSCOPE AND A BREAK IN THE CATHETER, WHERE THE CATHETER MEETS THE BALLOON, WAS NOTED. A PIECE OF PLASTIC WAS STICKING OUT AT THIS BREAK, WHICH HAD PREVENTED THE BALLOON FROM EXITING THE ENDOSCOPE. THE PROCEDURE WAS COMPLETED WITH ANOTHER 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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2010 THAT A CRE BALLOON DILATATION CATHETER WAS USED DURING A COLONOSCOPY STRICTURE DILATION PROCEDURE PERFORMED ON A (B)(6) MALE PATIENT ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON WOULD NOT EXIT THE WORKING CHANNEL OF THE ENDOSCOPE. THE BALLOON WAS REMOVED FROM THE ENDOSCOPE AND A BREAK IN THE CATHETER, WHERE THE CATHETER MEETS THE BALLOON, WAS NOTED. A PIECE OF PLASTIC WAS STICKING OUT AT THIS BREAK, WHICH HAD PREVENTED THE BALLOON FROM EXITING THE ENDOSCOPE. THE PROCEDURE WAS COMPLETED WITH ANOTHER 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(TM) BALLOON DILATATION CATHETER ENDOSCOPE AND/OR ACCESSORIES, DILATOR, ESOPHAGEAL KOG BOSTON SCIENTIFIC - CORK M00558500 13592622

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR OLYMPUS 2.8MM ENDOSCOPE