BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIMA? APDL

    MDR report key: 3212847 · Received July 9, 2013

    Report

    Report Number
    2134265-2013-04685
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 10, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FFA
    PMA / PMN Number
    K944290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE DEVICE WAS RECEIVED WITH THE SUTURE INSIDE THE CATHETER AND BROKEN NEAR TO THE SUTURE KEY. THE SUTURE KEY WAS NOT RETURNED. THE SUTURE HOLE IS RIPPED. THE METAL CANNULA, THE FLEXIBLE CANNULA AND THE TROCAR WERE RECEIVED AND NO ANOMALIES WERE FOUND. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSHEPATIC BILIARY DILATATION PROCEDURE, THE SUTURE BROKE. THE TARGET AREA IS LOCATED IN THE BILIARY REGION. A FLEXIMA REGULAR APDL/8 WAS SELECTED AND ADVANCED TO DRAIN THE TARGET AREA. DURING CLOSURE OF THE DRAINAGE, THE PHYSICIAN PULLED THE THREAD BUT THE SUTURE BROKE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION IS STABLE

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSHEPATIC BILIARY DILATATION PROCEDURE, THE SUTURE BROKE. THE TARGET AREA IS LOCATED IN THE BILIARY REGION. A FLEXIMA REGULAR APDL/8 WAS SELECTED AND ADVANCED TO DRAIN THE TARGET AREA. DURING CLOSURE OF THE DRAINAGE, THE PHYSICIAN PULLED THE THREAD BUT THE SUTURE BROKE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313643 FLEXIMA? APDL TUBE, DRAINAGE, SUPRAPUBIC FFA BOSTON SCIENTIFIC - COSTA RICA (COYOL) M001271340 0015734808

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR