BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RX ERCP CANNULA

    MDR report key: 3201064 · Received July 2, 2013

    Report

    Report Number
    3005099803-2013-06211
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    June 12, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    GCJ
    PMA / PMN Number
    K970054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EVALUATION OF THE RETURNED DEVICE FOUND THAT THE TIP OF THE DEVICE WAS INTACT. THE LENGTH OF THE BLUE PAINT BAND WAS MEASURED AND FOUND TO MEET SPECIFICATIONS. THERE WAS NO EVIDENCE THE TIP OF THE DEVICE HAD SEPARATED. BASED ON THIS FINDING, THIS IS NO LONGER CONSIDERED A REPORTABLE EVENT. THERE WAS NO EVIDENCE THE TIP OF THE DEVICE HAD SEPARATED. THE INVESTIGATION WAS UNABLE TO CONFIRM THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT EXPIRED. REPORTED EVENT: TIP OF CATHETER DETACHED. THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. 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 THAT A RX BILIARY CANNULA WAS USED DURING A STONE EXTRACTION PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHILE EXCHANGING THE GUIDEWIRE FOR A DIFFERENT GUIDEWIRE, 2-3 MM OF PLASTIC DETACHED FROM THE DISTAL TIP OF THE CATHETER AND REMAINED INSIDE THE PATIENT. THE PHYSICIAN IS NOT CONCERNED ABOUT THE DETACHED TIP AND EXPECTS IT TO PASS NATURALLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER RX BILIARY CANNULA. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RX BILIARY CANNULA WAS USED DURING A STONE EXTRACTION PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHILE EXCHANGING THE GUIDEWIRE FOR A DIFFERENT GUIDEWIRE, 2-3 MM OF PLASTIC DETACHED FROM THE DISTAL TIP OF THE CATHETER AND REMAINED INSIDE THE PATIENT. THE PHYSICIAN IS NOT CONCERNED ABOUT THE DETACHED TIP AND EXPECTS IT TO PASS NATURALLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER RX BILIARY CANNULA. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301564 RX ERCP CANNULA LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ BOSTON SCIENTIFIC - SPENCER M00545770

    Patients

    Seq Age Sex Outcome Treatment
    1