BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLYX SIS SYSTEM

    MDR report key: 2132670 · Received June 17, 2011

    Report

    Report Number
    3005099803-2011-01936
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    February 8, 2011
    Report Date
    May 23, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THIS LOT SHOWED NO EVIDENCE OF A MANUFACTURING RELATED POTENTIAL CAUSE FOR THIS EVENT. A VISUAL ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE DISTAL TIP OF THE DELIVERY DEVICE HAD DETACHED AND THE CLEAR TUBE OF THE DEPLOYMENT MECHANISM HAD BUCKLED. IT WAS ALSO FOUND THAT ONE OF THE MESH CARRIERS HAD DETACHED FROM THE MESH. THE DETACHED DELIVERY DEVICE TIP AND MESH CARRIER WERE NOT RETURNED. THE CUSTOMER CONFIRMED THAT THE CORRECT DEVICE WAS RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SOLYX SINGLE INCISION SLING SYSTEM WAS USED DURING A PROCEDURE. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN HAD DIFFICULTY LOADING ONE OF THE MESH CARRIERS ONTO THE DELIVERY DEVICE TIP. THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER SOLYX SLING SYSTEM WITHOUT ANY PATIENT COMPLICATIONS. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "FINE." THE EVENT, AS REPORTED, DOES NOT CONSTITUTE AN MDR REPORTABLE EVENT, HOWEVER, THE ANALYSIS OF THE RETURNED DEVICE REVEALED A REPORTABLE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLYX SIS SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068507000 1ML0092006

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR