BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS® SD RENAL/BILIARY

    MDR report key: 3062237 · Received April 16, 2013

    Report

    Report Number
    2134265-2013-02368
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Report Date
    March 18, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    FGE
    PMA / PMN Number
    K040027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR. 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 MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS RECEIVED FOR ANALYSIS. RETURNED PRODUCT CONSISTED OF AN EXPRESS SD STENT DELIVERY SYSTEM (SDS) WITH THE STENT AND AN EXPRESS SD INNER PACKAGING POUCH. THE BATCH NUMBER ON THE RETURNED PACKAGING AND THE SDS MATCHED THE REPORTED BATCH NUMBER. THERE WAS CONTRAST IN THE INFLATION LUMEN. THE BALLOON WAS TIGHTLY FOLDED WITH THE STENT SECURE BETWEEN THE MARKERBANDS. THE MID-SHAFT WAS KINKED 1.5CM AND 3CM FROM THE GUIDEWIRE EXIT NOTCH. THERE WAS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES CONTRIBUTING TO THE SHAFT KINKS. THERE WAS NO DAMAGE TO THE STENT. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS NOT CONFIRMED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. AS THE PHYSICIAN HAD DIFFICULTY ADVANCING A 7.0MMX15MMX150CM EXPRESS SD RENAL/BILIARY STENT IN THE PATIENT, THE DEVICE KINKED. THEY WERE NOT ABLE TO USE IT. THEY REMOVED THE STENT AND DID NOT DEPLOY IT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. AS THE PHYSICIAN HAD DIFFICULTY ADVANCING A 7.0MMX15MMX150CM EXPRESS SD RENAL/BILIARY STENT IN THE PATIENT, THE DEVICE KINKED. THEY WERE NOT ABLE TO USE IT. THEY REMOVED THE STENT AND DID NOT DEPLOY IT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163699 EXPRESS® SD RENAL/BILIARY CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - MAPLE GROVE H74937911715150 14863529

    Patients

    Seq Age Sex Outcome Treatment
    1