BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTRACTOR¿ RX

    MDR report key: 2203238 · Received August 11, 2011

    Report

    Report Number
    3005099803-2011-02708
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 20, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    FGE
    PMA / PMN Number
    K041606
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: VISUAL EVALUATION OF THE RETURNED COMPLAINT DEVICE CONFIRMED THAT THE DISTAL TIP TOGETHER WITH THE BALLOON BROKE OFF. THE CATHETER WAS FOUND TO BE STRETCHED, AND THE C-CHANNEL WAS FOUND TO BE DAMAGED, HAVING JAGGED EDGES AND THE CHANNEL WAS TORN. THIS IS CONSISTENT WITH THE GUIDE WIRE REMOVAL FROM THE CHANNEL WITH AN EXCESSIVE FORCE. INSPECTION OF THE CATHETER OF THE DEVICE REVEALED NO ISSUES. THE INVESTIGATION RESULTS ARE CONSISTENT WITH THE EVENT DESCRIPTION. THE REPORTED DEFECT OF DISTAL TIP DETACHED WAS CONFIRMED, HOWEVER THE REPORTED DEFECT OF BALLOON BURST COULD NOT BE CONFIRMED AS THE BALLOON WAS MISSING. 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 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

    PATIENT AGE AND WEIGHT ARE UNKNOWN. HOWEVER, IT WAS REPORTED THE PATIENT IS OVER 18 YEARS. (B)(4) - THE REPORTED EVENT OF CATHETER TIP DETACHMENT. 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 ON (B)(6), 2011 THAT AN EXTRACTOR RX BALLOON WAS USED DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE COMMON BILE DUCT (CBD) PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE, THE BALLOON BURST AND THE DISTAL TIP DETACHED. THE PHYSICIAN COMPLETED THE PROCEDURE WITH A TRAPEZOID BASKET RETRIEVING THE DISTAL TIP OF THE EXTRACTOR AS WELL AS THE REMAINING STONES. THE PHYSICIAN REPORTED THAT THERE WERE NO ISSUES WITH THE TRAPEZOID BASKET. 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 STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2011 THAT AN EXTRACTOR RX BALLOON WAS USED DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE COMMON BILE DUCT (CBD) PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE, THE BALLOON BURST AND THE DISTAL TIP DETACHED. THE PHYSICIAN COMPLETED THE PROCEDURE WITH A TRAPEZOID BASKET RETRIEVING THE DISTAL TIP OF THE EXTRACTOR AS WELL AS THE REMAINING STONES. THE PHYSICIAN REPORTED THAT THERE WERE NO ISSUES WITH THE TRAPEZOID BASKET. 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 STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTRACTOR¿ RX CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - CORK M00546920 14125791

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention