BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIMA¿ APDL

    MDR report key: 2190515 · Received August 4, 2011

    Report

    Report Number
    2134265-2011-03488
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    May 13, 2011
    Report Date
    July 7, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FFA
    PMA / PMN Number
    K944290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: ONLY THE ACCU-STICK WAS RETURNED. THE CATHETER DEVICE AND OTHER COMPONENTS WERE NOT RETURNED. IT PRESENTS SEVERAL KINKS ALONG THE BODY AND RESIDUE WAS FOUND. FOLLOWING A DETAILED DEVICE ANALYSIS, IT WAS NOTED THAT THE ACCUSTICK PRESENTED TWO KINKS LOCATED APPROXIMATELY 1.5 CM FROM THE TIP AND 3 CM FROM THE TIP. THE TIP OF THE DEVICE WAS BENT/DAMAGED. THE DEVICE IS NOT BROKEN. A 0.0385 IN. MANDREL WAS INTRODUCED INTO THE ACCUSTICK DILATOR AND PASSED FREELY AND WITHOUT RESISTANCE THROUGH THE DEVICE. THERE WAS NO OCCLUSION OR ANY TYPE OF ANOMALY NOTICED WITHIN THE ACCUSTICK'S LUMEN. 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).

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DRAINAGE CATHETER TREATMENT PROCEDURE, THE DRAINAGE CATHETER WAS PERFORATED BY THE GUIDE WIRE. THE PATIENT HAD AN ABSCESS IN HER LOWER RIGHT ABDOMEN. AN (B)(4) FIRM ALL PURPOSE DRAINAGE CATHETER WAS SELECTED. DURING INTRODUCTION OF THE GUIDE WIRE, IT BECAME KINKED AND ALSO PERFORATED THE DRAINAGE CATHETER. HOWEVER THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME WIRE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DRAINAGE CATHETER TREATMENT PROCEDURE, THE DRAINAGE CATHETER WAS PERFORATED BY THE GUIDE WIRE. THE PATIENT HAD AN ABSCESS IN HER LOWER RIGHT ABDOMEN. AN APDL/10/K FIRM ALL PURPOSE DRAINAGE CATHETER WAS SELECTED. DURING INTRODUCTION OF THE GUIDE WIRE, IT BECAME KINKED AND ALSO PERFORATED THE DRAINAGE CATHETER. HOWEVER THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME WIRE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIMA¿ APDL TUBE, DRAINAGE, SUPRAPUBIC FFA BOSTON SCIENTIFIC - COSTA RICA M001271990 13892907

    Patients

    Seq Age Sex Outcome Treatment
    1