BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX FLEX 10

    MDR report key: 452302 · Received April 3, 2003

    Report

    Report Number
    MW1028058
    Event Type
    Injury
    Date Received
    April 3, 2003
    Date of Event
    March 14, 2003
    Report Date
    March 24, 2003
    Manufacturer
    AFX INC.
    Product Code
    NEY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING ABLATION, PLUME OF SMOKE NOTED FROM PROBE. DEFORMITY NOTED MID SHEATH AFTER REMOVING PROBE. SECOND POBE USED, SAME DIFFICULTY.

    Description of Event or Problem · 1

    ADD'L INFO RECEIVED FROM MFR 5/30/03: THE RETURNED DEVICE WAS REPORTED AS A PLUME OF SMOKE NOTED FROM PROBE. DEFORMITY NOTED MID-SHEATH AFTER REMOVING PROBE. SECOND PROBE USED, SAME DIFFICULTY. THE DEVICE WAS RETAINED BY THE REPORTING FACILITY AND THEREFORE NOT AVAILABLE FOR EVALUATION. ADDITIONALLY THE INITIAL REPORT OF THE PRODUCT PROBLEM BY THE SURGEON DOES NOT FULLY SUPPORT THE EVENT DESCRIPTION DOCUMENTED IN THE MDR. FROM THE PHOTOGRAPH PROVIDED BY THE FACILITY, AND SICUSSIONS WITH THE SURGEON, IT IS THEORIZED THAT THE PRODUCT DEFORMITY NOTED MID-SHEATH WAS CAUSED BY EXCESSIVE FORCE TO THE GUIDE LEAD. THE PLUME OF SMOKE CANNOT BE CONFIRMED OR FURTHER EVALUATED. AS NOTED IN THE ABOVE RESPONSE THE PLUME OF SMOKE COULD NOT BE CONFIRMED. IT IS THEREFORE ASSUMED THAT THE DIFFICULTY REFERRED TO, AS ENCOUNTERED BY THE SECOND PROBE, WAS THE DEFORMITY NOTED MID-SHEATH. NO EVIDENCE OF SMOKE WAS OBSERVED DURING THE DEVICE EVALUATION. IT IS THEREFORE ASSUMED THAT THE SAME DIFFICULT REFERRED TO IN THE SECOND PROBE'S FAILURE MODE IS THAT OF THE DEFORMITY NOTED MID-SHEATH. IT IS BELIEVED THAT THE EXTREME CLAMPING BY THE SURGEON HAD REDUCED THE LUMEN AND PREVENTED THE ANTENNA FROM TRANSLATING PROPERLY CAUSING THE DEVICE KINK OR SNAKE MID-SHEATH. BASED ON THE FAILURE ANALYSIS AND TEST RESULTS, IT IS CONCLUDED THAT THE DEVICE WAS DIFFICULT TO POSITION DUE TO THE REDUCED ANTENNA LUMEN DIMENSIONS RESULTING FROM THE EXTREME CLAMPING BY TH SURGEON. WHEN FORCE WAS APPLIED THE DEVICE WOULD THEN "SNAKE" MAKING IT DIFFICULT TO POSITION, AS IT WOULD NOT LAY FLAT. IFU 900119 HAS BEEN REVISED TO INCORPORATE THE FOLLOWING CAUTION: DO NOT PINCH OR GRASP THE FLEXIBLE SHEATH WITH EXCESSIVE FORCE. THIS MAY CAUSE DEVICE TO BECOME INOPERABLE.

    Description of Event or Problem · 1

    ADD'L INFO RECEIVED FROM RPTR 5/22/03: ABLE TO COMPLETE PROCEDURE WITHOUT COMPLICATION. INITIAL REPORT SUBMITTED ON 03/26/03 INDICATED THAT THIS PRODUCT PROBLEM REQUIRED INTERVENTION, HOWEVER UPON FURTHER REVIEW THIS WAS NOT THE CASE. THE SURGEON WAS ABLE TO COMPLETE THE PROCEDURE IN AN UNEVENTFUL MANNER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AFX FLEX 10 SURGICAL ABLATION DEVICE NEY AFX INC. * *
    2 AFX FLEX 10 SURGICAL ABLATION DEVICE NEY AFX INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention