BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPID EXCHANGE BILIARY BALLOON DILATATION CATHETER

    MDR report key: 1823893 · Received September 2, 2010

    Report

    Report Number
    3005099803-2010-03770
    Event Type
    Malfunction
    Date Received
    September 2, 2010
    Date of Event
    August 12, 2010
    Report Date
    August 12, 2010
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    FGE
    PMA / PMN Number
    K001338
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRELIMINARY INVESTIGATION RESULTS. THE RETURNED DEVICE WAS FOUND TO BE FROM LOT NUMBER 6143264, WHICH IS DIFFERENT THAN THE INITIALLY REPORTED LOT NUMBER. THE CUSTOMER HAS BEEN CONTACTED TO CONFIRM THAT THE CORRECT DEVICE WAS RETURNED FOR EVALUATION, HOWEVER NO INFORMATION HAS BEEN RECEIVED. THEREFORE, THIS EVALUATION REFLECTS THE CONDITION OF THE RETURNED DEVICE (LOT NUMBER 6143264). A VISUAL EXAMINATION FOUND THE CONDITION OF THE RETURNED DEVICE WAS NOT CONSISTENT WITH THE EVENT DESCRIPTION THAT THE BALLOON BURST; HOWEVER, A PINHOLE WAS NOTED IN THE BALLOON. NO OTHER DAMAGE WAS NOTED ON THE DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. A SEARCH OF THE COMPLAINT DATABASE REVEALED THERE WERE NO SIMILAR COMPLAINTS REPORTED FOR THIS LOT. IT WAS ALSO REVEALED THE DEVICE WAS USED PAST ITS EXPIRATION DATE. THE CORRECTED LOT NUMBER IS 6143264. THE CORRECTED DEVICE EXPIRATION DATE IS (B)(6), 2005. THE CORRECTED DEVICE MANUFACTURED DATE IS (B)(6), 2003.

    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 MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2010 THAT AN RX BILIARY BALLOON DILATATION CATHETER AND JAGWIRE WERE USED DURING A STENTING PROCEDURE PERFORMED ON A (B)(6) OLD MALE PATIENT ON (B)(6), 2010 (WEIGHT IS UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS DIFFICULT TO ADVANCE THE BALLOON DUE TO TORTUOUS ANATOMY, AND WHILE ATTEMPTING TO DILATE THE LOWER BILE DUCT, THE BALLOON BURST. NO PIECES OF THE BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER RX BILIARY BALLOON DILATATION CATHETER. THERE WAS NO ALLEGED MALFUNCTION OF THE JAGWIRE USED IN 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 GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2010 THAT AN RX BILIARY BALLOON DILATATION CATHETER AND JAGWIRE WERE USED DURING A STENTING PROCEDURE PERFORMED ON A (B)(6) MALE PATIENT ON (B)(6), 2010 (WEIGHT IS UNKNOWN).ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS DIFFICULT TO ADVANCE THE BALLOON DUE TO TORTUOUS ANATOMY, AND WHILE ATTEMPTING TO DILATE THE LOWER BILE DUCT, THE BALLOON BURST. NO PIECES OF THE BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER RX BILIARY BALLOON DILATATION CATHETER. THERE WAS NO ALLEGED MALFUNCTION OF THE JAGWIRE USED IN 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 GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPID EXCHANGE BILIARY BALLOON DILATATION CATHETER CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - CORK M00545940 6143264

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR (B)(4) ENDOSCOPE (OLYMPUS)| INFLATOR (CREATE MEDIC CORP.)| JAGWIRE PLUS 0.035INCH 460CM (BSC)