BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE¿ WIREGUIDED

    MDR report key: 2241806 · Received September 9, 2011

    Report

    Report Number
    3005099803-2011-03143
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 11, 2011
    Report Date
    August 19, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KOG
    PMA / PMN Number
    K974788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT OF BALLOON HOLE IN MATERIAL. PRELIMINARY INVESTIGATION RESULTS: VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND NO DAMAGE TO THE CATHETER OF THE DEVICE. HOWEVER, THROUGH FUNCTIONAL TESTING, IT WAS REVEALED THAT A PINHOLE WAS PRESENT IN THE BALLOON MATERIAL. THE INVESTIGATION RESULTS ARE CONSISTENT WITH THE EVENT DESCRIPTION. THE REPORTED DEFECT OF BALLOON LEAK AND INFLATION DIFFICULTY WAS CONFIRMED, AS A PINHOLE WAS NOTED TO THE BALLOON MATERIAL. THIS FAILURE LIKELY OCCURRED DUE TO ANATOMICAL/PROCEDURAL FACTORS WHICH LIMITED THE PERFORMANCE OF THE BALLOON. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. 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.

    Additional Manufacturer Narrative · 1

    CORRECTED INVESTIGATION RESULTS: VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND NO DAMAGE TO THE CATHETER OF THE DEVICE. HOWEVER, THROUGH FUNCTIONAL TESTING IT WAS REVEALED THAT A PINHOLE WAS PRESENT IN THE BALLOON MATERIAL. THE INVESTIGATION RESULTS ARE CONSISTENT WITH THE EVENT DESCRIPTION. THE REPORTED DEFECT OF BALLOON LEAK AND INFLATION DIFFICULTY WAS CONFIRMED, AS A PINHOLE WAS NOTED TO THE BALLOON MATERIAL. THIS FAILURE LIKELY OCCURRED DUE TO ANATOMICAL/PROCEDURAL FACTORS WHICH LIMITED THE PERFORMANCE OF THE BALLOON. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. 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 THAT A CRE BALLOON DILATATION CATHETER WAS USED DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINT, THE BALLOON NEVER INFLATED. IT WAS CONFIRMED THAT THE BALLOON DID NOT BURST, BUT THEY FOUND INJECTION CONTRAST LEAKING FROM THE BALLOON. THEY CONFIRMED THAT THERE WERE NO SHARP OBJECTS IN THE AREA OF DILATATION AND THAT NO PIECES OF THE DEVICE DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE BALLOON. 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 BE FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE BALLOON DILATATION CATHETER WAS USED DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PERFORMED ON (B)(6) 2011. ACCORDING TO THE COMPLAINT, THE BALLOON NEVER INFLATED. IT WAS CONFIRMED THAT THE BALLOON DID NOT BURST, BUT THEY FOUND INJECTION CONTRAST LEAKING FROM THE BALLOON. THEY CONFIRMED THAT THERE WERE NO SHARP OBJECTS IN THE AREA OF DILATATION AND THAT NO PIECES OF THE DEVICE DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE BALLOON. 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 BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRE¿ WIREGUIDED ENDOSCOPE AND/OR ACCESSORIES, DILATOR, ESOPHAGEAL KOG BOSTON SCIENTIFIC - CORK M00558390 14161550

    Patients

    Seq Age Sex Outcome Treatment
    1