BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XCELA POWER INJECTABLE PLASTIC TITANIUM PORT

    MDR report key: 2888748 · Received December 18, 2012

    Report

    Report Number
    2032582-2012-00015
    Event Type
    Malfunction
    Date Received
    December 18, 2012
    Report Date
    December 19, 2012
    Manufacturer
    PFM MEDICAL, INC
    Product Code
    LJT
    PMA / PMN Number
    K072481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION OF THE RETURNED PRODUCT INDICATED THAT ONLY ONE OF THE TWO PORTS RETURNED HAD A FRACTURE OF THE CATHETER. (SEE (B)(4) FOR INVESTIGATION RESULTS FOR LOT #10981 000). THE DEVICE FROM LOT NUMBER 110924 000 WAS ALSO RETURNED FOR INVESTIGATION, BUT NO FRACTURE WAS DETECTED ON THE CATHETER OF THIS PORT. A FLUSH TEST WAS ALSO CONDUCTED ON THIS PORT TO VERIFY ITS FUNCTIONALITY AND THERE WERE NO DIFFICULTIES IN PUNCTURING THIS SEPTUM. NO LEAKAGE WAS DETECTED WHEN THE EXTREMITY OF THE CATHETER WAS CLAMPED DURING THE FLUSH. THERE WERE NO PROBLEMS WITH THIS PORT; THE PORT WAS NOT OCCLUDED AND THE CATHETER HAD NO DEFECT. A SECOND TEST WAS CONDUCTED BY INJECTING A SOLUTION UNDER PRESSURE IN THE SYSTEM (4 BARS) IN ORDER TO VERIFY THE FIRST RESULT OF THE INVESTIGATION. NO LEAKAGE OF THE INJECTED SOLUTION FROM THE SYSTEM WAS CONFIRMED. THE CATHETER WAS ALSO INSPECTED AND NO FRACTURE WAS FOUND - EVEN BY VISUAL INSPECTION WITH 10X MAGNIFICATION. BASED ON OUR INVESTIGATION, WE WERE NOT ABLE TO DUPLICATE THE DEFECT. NO LEAKAGE WAS DETECTED ON THE RETURNED PORT SYSTEM. THE FOLLOWING REVIEWS WERE CONDUCTED AND THEIR RESPECTIVE RESULTS WERE FOUND: INVENTORY ASSESSMENT: THERE ARE NO MORE PIECES FROM THIS LOT IN STOCK. THE COMPLETE LOT OF 200 PIECES WAS DELIVERED BETWEEN (B)(6) 2011. RISK MANAGEMENT REVIEW: THE RISK OF PINCH-OFF RESULTING TO A "CATHETER FRACTURE" WAS IDENTIFIED IN OUR RISK ANALYSIS. A REVIEW OF THE INSTRUCTIONS FOR USE INDICATED DETAILED/ADEQUATE INSTRUCTIONS FOR POR CATHETER PLACEMENT AND PINCH-OFF WARNING. REVIEW OF SIMILAR COMPLAINTS: NO SIMILAR COMPLAINT WAS IDENTIFIED FOR THIS PORT LOT NUMBER 110924 000. ONE OTHER SIMILAR COMPLAINT WAS REPORTED FOR THIS INCIDENT; REFERENCE (B)(4). WITHIN THE LAST THREE YEARS, THERE WERE FOUR OTHER SIMILAR COMPLAINTS WITH SIMILAR REPORTED PROBLEMS OF EXTRAVASION FOLLOWING CATHETER LEAKAGE AND/OR CATHETER FAILURE. INVESTIGATIVE CONCLUSIONS FOR THESE FOUR COMPLAINTS WERE "PINCH-OFF GRADE 3". DEVICE HISTORY RECORD (DHR) REVIEW: THE REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO NON-CONFORMITIES WITH THE LOT OF VASCULAR ACCESS SYSTEM. BASED ON OUR INVESTIGATION, WE ARE NOT ABLE TO RECREATE THE DEFECT CONDITIONS. NO LEAKAGE WAS DETECTED ON THE RETURNED PORT SYSTEM. NO CORRECTIVE OR PREVENTATIVE ACTION WAS OPENED. PFM WILL CONTINUE TO MONITOR THESE TYPES OF SIMILAR COMPLAINTS IN THE FUTURE. METHOD: REVIEWING ALL LABELING (INCLUDING INSTRUCTIONS FOR USE, MANUALS, AND PACKAGING) FOR LANGUAGE RELATED TO REPORTED DEVICE PROBLEMS. RESULT: DEVICE PROBLEMS CAUSED BY EITHER EXCESSIVE OR INADEQUATE PHYSICAL FORCE EXERTED ON IT BY ANOTHER OBJECT, RESULTING IN PROBLEMS, E.G. WEAR, BENDING, DEFORMATION, FRACTURE, FATIGUE. DEVICE PROBLEMS CAUSED BY CHANGES IN THE SHAPE OR SIZE OF THE DEVICE OR DEVICE COMPONENT DUE TO AN APPLIED FORCE. THIS CAN BE A RESULT OF TENSILE FORCES, COMPRESSIVE FORCES, SHEAR, BENDING, TENSILE (PULLING), OR TORSION. CONCLUSION: DEVICE PROBLEMS KNOWN AND DOCUMENTED IN THE LABELING (INCLUDING BOTH SHORT OR LONG TERM KNOWN COMPLICATIONS OR ADVERSE REACTIONS). A DEVICE PROBLEM RELATED TO THE USER NOT FOLLOWING THE MFR'S INSTRUCTIONS. A DEVICE PROBLEM RELATED TO THE OPERATOR'S TECHNIQUE OR USE ENVIRONMENT.

    Description of Event or Problem · 1

    THE COMPLAINANT STATED THAT 2 XCELA PORTS WERE RETURNED BECAUSE THE "CATHETER WAS FRACTURED UP NEAR THE PORT". (SEE (B)(4)/MDR# 2032582-2012-00014 FOR OTHER PORT INVOLVED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XCELA POWER INJECTABLE PLASTIC TITANIUM PORT XCELA PORT LJT PFM MEDICAL, INC H965451190 110924 000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention