BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRE¿ WIREGUIDED

    MDR report key: 2637794 · Received July 2, 2012

    Report

    Report Number
    3005099803-2012-02542
    Event Type
    Injury
    Date Received
    July 2, 2012
    Date of Event
    June 7, 2012
    Report Date
    June 7, 2012
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KNQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE AND WEIGHT ARE UNKNOWN. HOWEVER, IT WAS REPORTED THE PATIENT IS OVER 18 YEARS. THE 510K NUMBER IS K112994. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MED WATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE COMPLAINT DEVICE FOUND NO DAMAGE TO THE CATHETER PORTION OF THE DEVICE. THE BALLOON WAS INSPECTED AND INFLATED USING AN ALLIANCE SYRINGE AND NO DEFECTS WERE NOTED. IT INFLATED WITHOUT ISSUE UP TO ITS MAXIMUM INFLATION PRESSURE AND DIAMETER AND DID NOT EXCEED ITS MAXIMUM OUTER INFLATION DIAMETER. THE REPORTED EVENT OF PATIENT PERFORATION COULD NOT BE CONFIRMED THROUGH PRODUCT ANALYSIS. THE BALLOON WAS ABLE TO BE INFLATED WITHOUT ANY ISSUES OR DEFECTS. THE DEVICE WAS FOUND TO OPERATE WITHIN SPECIFICATION. THEREFORE, THE MOST PROBABLE ROOT CAUSE OF THIS EVENT IS ANTICIPATED PROCEDURAL COMPLICATION AS THE REPORTED EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE NOTED WITHIN THE DFU FOR THIS PRODUCT. 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. A REVIEW OF THE DEVICE LABELING AND DIRECTIONS FOR USE (DFU) WAS PERFORMED AND SHOWED THE DEVICE WAS USED IN ACCORDANCE WITH ITS LABELING.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2012-02529, # 3005099803-2012-02542, AND # 3005099803-2012-02543 ADDRESS THESE DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE BALLOON DILATATION CATHETER, A DREAMWIRE GUIDEWIRE, AND AN EXTRACTOR PRO RETRIEVAL BALLOON WERE USED ON (B)(6), 2012 DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE BILE DUCT. ACCORDING TO THE COMPLAINANT, A SPHINCTEROPLASTY WAS PERFORMED WITH A CRE BALLOON DILATATION CATHETER (# 3005099803-2012-02542) AND A DREAMWIRE GUIDEWIRE (# 3005099803-2012-02529) TO ALLOW THE PASSAGE OF LARGE GALLSTONES. THE CRE BALLOON DILATATION CATHETER WAS REMOVED, AND THE DREAMWIRE GUIDEWIRE WAS LEFT IN THE BILE DUCT. AN EXTRACTOR PRO RETRIEVAL BALLOON (# 3005099803-2012-02543) WAS THEN USED TO RETRIEVE THE GALLSTONES. IT WAS ALSO REPORTED A NON-BSC LITHOTRIPTER WAS USED DURING THE PROCEDURE. ONCE THE DEVICES HAD BEEN USED FOR APPROXIMATELY 20 MINUTES AND THE PROCEDURE WAS COMPLETED, A SMALL BILIARY DUCT PERFORATION WAS NOTED BY CONTRAST PASSING INTO THE DUODENUM. A FULLY COVERED METAL STENT WAS PLACED TO SUCCESSFULLY CLOSE THE PERFORATION. IT WAS CONFIRMED THERE WAS NO MALFUNCTION OF ANY OF THE BSC DEVICES. ACCORDING TO THE PHYSICIAN, IT WAS NOT POSSIBLE TO DETERMINE WHICH DEVICE CAUSED THE PERFORATION. THE PATIENT WAS REPORTED AS STABLE POST PROCEDURE.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2012-02529, # 3005099803-2012-02542, AND # 3005099803-2012-02543 ADDRESS THESE DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CRE BALLOON DILATATION CATHETER, A DREAMWIRE GUIDEWIRE, AND AN EXTRACTOR PRO RETRIEVAL BALLOON WERE USED ON (B)(6) 2012 DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE BILE DUCT. ACCORDING TO THE COMPLAINANT, A SPHINCTEROPLASTY WAS PERFORMED WITH A CRE BALLOON DILATATION CATHETER (# 3005099803-2012-02542) AND A DREAMWIRE GUIDEWIRE (# 3005099803-2012-02529) TO ALLOW THE PASSAGE OF LARGE GALLSTONES. THE CRE BALLOON DILATATION CATHETER WAS REMOVED, AND THE DREAMWIRE GUIDEWIRE WAS LEFT IN THE BILE DUCT. AN EXTRACTOR PRO RETRIEVAL BALLOON (# 3005099803-2012-02543) WAS THEN USED TO RETRIEVE THE GALLSTONES. IT WAS ALSO REPORTED A NON-BSC LITHOTRIPTER WAS USED DURING THE PROCEDURE. ONCE THE DEVICES HAD BEEN USED FOR APPROXIMATELY 20 MINUTES AND THE PROCEDURE WAS COMPLETED, A SMALL BILIARY DUCT PERFORATION WAS NOTED BY CONTRAST PASSING INTO THE DUODENUM. A FULLY COVERED METAL STENT WAS PLACED TO SUCCESSFULLY CLOSE THE PERFORATION. IT WAS CONFIRMED THERE WAS NO MALFUNCTION OF ANY OF THE BSC DEVICES. ACCORDING TO THE PHYSICIAN, IT WAS NOT POSSIBLE TO DETERMINE WHICH DEVICE CAUSED THE PERFORATION. THE PATIENT WAS REPORTED AS STABLE POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRE¿ WIREGUIDED BALLOON DILATOR KNQ BOSTON SCIENTIFIC - CORK M00558690 14805482

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention