BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDROGEL COATED PERCUFLEX(R) DRAINAGE CATHETERS

    MDR report key: 2023886 · Received March 18, 2011

    Report

    Report Number
    3005099803-2011-00742
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 24, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FGE
    PMA / PMN Number
    K924608
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BUT AN EVALUATION HAS NOT YET BEEN PERFORMED; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED. AT THIS TIME, WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE FOR THE EVENT.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED PERCUFLEX PLUS URETERAL STENT REVEALED THE RETURNED UNIT WAS CONSISTENT WITH THE COMPLAINT INCIDENT THAT THE DEVICE PACKAGE SEAL WAS COMPROMISED. DURING MANUFACTURING, THE DEVICES ARE 100% INSPECTED FOR PACKAGING INTEGRITY. MOST LIKELY, THE SEAL WAS BROKEN DURING SHIPMENT TO THE CUSTOMER OR AT THE CUSTOMER SITE PRIOR TO THE PROCEDURE. THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THIS EVENT IS DETERMINED TO BE HANDLING DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDROGEL COATED PERCUFLEX DRAINAGE CATHETER PACKAGE WAS UNSEALED. ACCORDING TO THE COMPLAINANT, THE STERILE SEAL SURROUNDING THE DEVICE WAS NOT SEALED. IT WAS CONFIRMED THAT NO DAMAGE WAS NOTICED TO THE SHIPPING BOX, ONLY ONE PACKAGE WAS UNSEALED. THIS EVENT OCCURRED DURING UNPACKING, THEREFORE NO PATIENT WAS INVOLVED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDROGEL COATED PERCUFLEX DRAINAGE CATHETER PACKAGE WAS UNSEALED. ACCORDING TO THE COMPLAINANT, THE STERILE SEAL SURROUNDING THE DEVICE WAS NOT SEALED. IT WAS CONFIRMED THAT NO DAMAGE WAS NOTICED TO THE SHIPPING BOX, ONLY ONE PACKAGE WAS UNSEALED. THIS EVENT OCCURRED DURING UNPACKING, THEREFORE NO PATIENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDROGEL COATED PERCUFLEX(R) DRAINAGE CATHETERS CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - SPENCER M0061751980 13538641

    Patients

    Seq Age Sex Outcome Treatment
    1