BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XCELA POWER INJECTABLE PLASTIC TITANIUM PORT

    MDR report key: 2888747 · Received December 18, 2012

    Report

    Report Number
    2032582-2012-00014
    Event Type
    Malfunction
    Date Received
    December 18, 2012
    Date of Event
    August 12, 2012
    Report Date
    December 19, 2012
    Manufacturer
    PFM MEDICAL, INC
    Product Code
    LJT
    PMA / PMN Number
    K72481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT STATED THAT 2 XCELA PORTS WERE RETURNED BECAUSE THE "CATHETER WAS FRACTURED UP NEAR THE PORT". (REFERENCE (B)(4)/MDR#203582-2012-00015 FOR OTHER PORT INCLUDED IN COMPLAINT). AN INVESTIGATION OF THE RETURNED PRODUCT INDICATED THAT ONLY ONE OF THE TWO PORTS RETURNED HAD A FRACTURE OF THE CATHETER. THE DEVICE FROM LOT#110981 000 HAD 4MM LONG FRACTURE OF THE CATHETER AT ABOUT 13CM FROM THE PORT. A FLUSH TEST WAS CONDUCTED TO VERIFY THE FUNCTIONALITY OF THIS RETURNED PORT. THERE WAS NO DIFFICULTY TO PUNCTURE THE SEPTUM. THIS PORT WAS NOT OCCLUDED BUT BY CLAMPING THE END OR THE CATHETER, THE FRACTURE OF THE CATHETER WAS DETECTED BY A LEAKAGE OF THE INJECTED SOLUTION. THE CATHETER WAS ALSO INSPECTED AND THERE WAS SOME EVIDENCE OF COMPRESSION WHERE THE CATHETER WAS FRACTURED. BASED ON OUR INVESTIGATION IT IS CONCLUDED THAT THE FAILURE WAS DUE TO A PINCH-OFF OF GRADE 3; TRANSACTION OR FRACTURE OF THE CATHETER. WE SUSPECT THAT THE CATHETER, INSERTED TO THE LEFT OF THE SUBCLAVIAN, WAS COMPRESSED BETWEEN THE FIRST RIB AND THE CLAVICLE. THIS "PINCH-OFF" EFFECT IS VERY WELL DESCRIBED IN LITERATURE AND IN OUR INSTRUCTION FOR USE. THE FOLLOWING REVIEWS WERE CONDUCTED AND THEIR RESPECTIVE RESULTS WERE FOUND: AN INVENTORY ASSESSMENT INDICATED THAT THERE ARE NO MORE PIECES FROM THIS LOT IN STOCK. (B)(4). ONE OTHER SIMILAR COMPLAINT WAS REPORTED FOR "CATHETER FOUND KINKED IN KIT". THE DHR REVIEW INDICATED THAT ALL QUALITY RECORDS FOR LOT# 110981 000 ((B)(4)) WERE COMPLETE AND IN ORDER. THIS REVIEW SHOWED NO NON-CONFORMITIES ASSOCIATED WITH THIS LOT FOR VASCULAR ACCESS SYSTEM. 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 PORT CATHETER PLACEMENT AND PINCH-OFF WARNING. THE FAILURE WAS ATTRIBUTED TO A "PINCH-OFF GRADE 3" (TRANSACTION OR FRACTURE OR THE CATHETER). NO CORRECTIVE OR PREVENTIVE ACTION WAS OPENED. PFM WILL CONTINUE TO MONITOR THESE TYPES OF SIMILAR COMPLAINTS IN THE FUTURE. MANUFACTURER EVALUATION: 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 PROBLEM 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.

    Description of Event or Problem · 1

    THE COMPLAINANT STATED THAT 2 XCELA PORTS WERE RETURNED BECAUSE THE "CATHETER WAS FRACTURED UP NEAR THE PORT". UPDATED INFORMATION RECEIVED BY PFM ON (B)(6) 2012: "VENOGRAM (B)(6) 2012 - "LEAKING OF CONTRAST MEDIUM IN THE PORT-A-CATH NEAR THE PORT AND VERY LITTLE FILLING DISTAL TO THE LEAKING".

    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 110981000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention