BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTOR RX RETRIEVAL BALLOON

    MDR report key: 1931631 · Received December 17, 2010

    Report

    Report Number
    3005099803-2010-05150
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    October 26, 2010
    Report Date
    November 24, 2010
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    FGE
    PMA / PMN Number
    K041606
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ZA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE AND WEIGHT ARE UNKNOWN. THE PATIENT WAS REPORTED TO BE OVER 18 YEARS OLD. VISUAL EVALUATION OF THE RETURNED COMPLAINT DEVICE CONFIRMED THE BALLOON TO BE BURST. INSPECTION OF THE CATHETER OF THE DEVICE REVEALED A KINK BELOW THE BALLOON AND DAMAGE TO THE C-CHANNEL. THE DAMAGED C-CHANNEL CREATED A JAGGED EDGE IN THE SECTION OF THE CATHETER THAT MAY BE INSERTED INTO THE PATIENT. CONTRAST CRYSTALS WERE ALSO FOUND ON THE DISTAL PART OF THE CATHETER AND THE REMAINS OF THE BALLOON, CONSISTENT WITH CONTRAST INJECTION DURING THE PROCEDURE. THE DAMAGE NOTED TO THE CATHETER OF THE DEVICE MAY BE DUE TO EXCESSIVE FORCE USED IN REMOVING THE GUIDEWIRE FROM THE C-CHANNEL. BALLOON BURST MOST LIKELY OCCURRED DUE TO CONTACT WITH A SHARP EXTERIOR SOURCE (SUCH AS A STONE). BASED ON THIS INFORMATION, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS OPERATIONAL CONTEXT; THIS FAILURE OCCURS WHEN PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE LIMIT THE PERFORMANCE OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    THE DATE IN THE "DATE OF THIS REPORT" AND "DATE RECEIVED BY MANUFACTURER" FIELDS OF THE INITIAL MDR SENT ON (B)(6) 2010 WERE ENTERED INCORRECTLY. THE DATE ENTERED IN ERROR WAS (B)(6) 2010; THE CORRECT DATE IS (B)(6) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2010 THAT AN EXTRACTOR RX RETRIEVAL BALLOON WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON A FEMALE PATIENT ON (B)(6), 2010 (PATIENT AGE AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, CANNULATION WAS ACHIEVED AND THE BALLOON WAS POSITIONED IN THE COMMON BILE DUCT PAST THE STONE BEING RETRIEVED. THE BALLOON WAS THEN INFLATED TO 15MM AND STONE RETRIEVAL WAS ATTEMPTED, BUT WAS UNSUCCESSFUL. THE BALLOON WAS POSITIONED PAST THE STONE AGAIN, AND WAS INFLATED TO 12MM. STONE RETRIEVAL WAS THEN ATTEMPTED, HOWEVER THE BALLOON BURST. NO PIECES OF THE BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR RX RETRIEVAL BALLOON. 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 STABLE. NO ADDITIONAL DAMAGE WAS REPORTED BY THE COMPLAINANT, BUT ON (B)(6), 2010 THE EVALUATION REVEALED THE CATHETER WAS DAMAGED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2010 THAT AN EXTRACTOR RX RETRIEVAL BALLOON WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON A FEMALE PATIENT ON (B)(6) 2010 (PATIENT AGE AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, CANNULATION WAS ACHIEVED AND THE BALLOON WAS POSITIONED IN THE COMMON BILE DUCT PAST THE STONE BEING RETRIEVED. THE BALLOON WAS THEN INFLATED TO 15 MM AND STONE RETRIEVAL WAS ATTEMPTED, BUT WAS UNSUCCESSFUL. THE BALLOON WAS POSITIONED PAST THE STONE AGAIN, AND WAS INFLATED TO 12 MM. STONE RETRIEVAL WAS THEN ATTEMPTED, HOWEVER THE BALLOON BURST. NO PIECES OF THE BALLOON DETACHED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXTRACTOR RX RETRIEVAL BALLOON. 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 STABLE. NO ADDITIONAL DAMAGE WAS REPORTED BY THE COMPLAINANT, BUT ON (B)(6) 2010 THE EVALUATION REVEALED THE CATHETER WAS DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTRACTOR RX RETRIEVAL BALLOON CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - CORK M00546910 13534658

    Patients

    Seq Age Sex Outcome Treatment
    1