BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTRACTOR? PRO RX

    MDR report key: 4003879 · Received August 12, 2014

    Report

    Report Number
    3005099803-2014-02777
    Event Type
    Injury
    Date Received
    August 12, 2014
    Date of Event
    July 22, 2014
    Report Date
    July 24, 2014
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    FGE
    PMA / PMN Number
    K102082
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE COMPLAINT DEVICE REVEALED THAT THE CATHETER WAS BROKEN AT THE BALLOON HUB. THE DISTAL TIP WAS DETACHED AND WAS NOT RETURNED FOR ANALYSIS. THE C-CHANNEL WAS TORN TOWARDS THE DISTAL END. THE REPORTED COMPLAINT AND DISTAL TIP DETACHED WAS CONFIRMED; HOWEVER BALLOON BURST COULD NOT BE CONFIRMED BECAUSE IT WAS NOT RETURNED. IN THE CASE OF THIS COMPLAINT THE CATHETER BROKE MOST LIKELY DURING DEVICE REMOVAL FROM THE SCOPE. IT IS MOST LIKELY THAT A STONE PRESENT IN THE BILE DUCT BLOCKED THE CATHETER OR THE CATHETER WAS CAUGHT BY SCOPE ELEVATOR; THIS HOWEVER CANNOT BE CONCLUSIVELY DETERMINED. THE DEFECT NOTED TO THE C-CHANNEL IS CONSISTENT WITH GUIDE WIRE REMOVAL FROM THE CHANNEL WITH EXCESSIVE FORCE. 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 OTHER COMPLAINTS EXIST FOR THE SPECIFIED LOT. A LABELING REVIEW WAS PERFORMED AND FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL.

    Additional Manufacturer Narrative · 1

    THE EXACT AGE OF THE PATIENT IS UNKNOWN, HOWEVER, IT WAS REPORTED THE PATIENT WAS OVER 18 YEARS. THE COMPLAINANT WAS UNABLE TO PROVIDE THE DEVICE LOT NUMBER. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT EXPIRED. REPORTED EVENT OF DISTAL TIP DETACHED. 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 THAT AN EXTRACTOR PRO RETRIEVAL BALLOON WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) IN THE COMMON BILE DUCT PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, ON THE THIRD PASS WITH THE EXTRACTOR PRO BALLOON, THE DISTAL TIP OF THE CATHETER DETACHED AND THE BALLOON BURST. ANOTHER EXTRACTOR WAS USED IN AN ATTEMPT TO REMOVE THE DISTAL TIP, HOWEVER THIS PUSHED THE TIP INTO THE COMMON HEPATIC DUCT. REPORTEDLY, THE DISTAL TIP WAS SUCCESSFULLY REMOVED FROM THE PATIENT¿S BODY WITH A HURRICANE BALLOON AND A SNARE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE AND THERE WERE NO FURTHER COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT HAD A LAPAROSCOPIC CHOLECYSTECTOMY FOUR DAYS LATER (A PLANNED PROCEDURE THAT WAS SCHEDULED PRIOR TO THE ERCP PROCEDURE). THE PATIENT PRESENTED WITH A SUB-CAPSULAR HEMATOMA THREE DAYS AFTER THE PLANNED CHOLECYSTECTOMY.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXTRACTOR PRO RETRIEVAL BALLOON WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) IN THE COMMON BILE DUCT PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, ON THE THIRD PASS WITH THE EXTRACTOR PRO BALLOON, THE DISTAL TIP OF THE CATHETER DETACHED AND THE BALLOON BURST. ANOTHER EXTRACTOR WAS USED IN AN ATTEMPT TO REMOVE THE DISTAL TIP, HOWEVER THIS PUSHED THE TIP INTO THE COMMON HEPATIC DUCT. REPORTEDLY, THE DISTAL TIP WAS SUCCESSFULLY REMOVED FROM THE PATIENT¿S BODY WITH A HURRICANE BALLOON AND A SNARE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE AND THERE WERE NO FURTHER COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT HAD A LAPAROSCOPIC CHOLECYSTECTOMY FOUR DAYS LATER (A PLANNED PROCEDURE THAT WAS SCHEDULED PRIOR TO THE ERCP PROCEDURE). THE PATIENT PRESENTED WITH A SUB-CAPSULAR HEMATOMA THREE DAYS AFTER THE PLANNED CHOLECYSTECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480893 EXTRACTOR? PRO RX CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - CORK M00547000 17034577

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention