BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER, ELECTRODE RECORDING

    MDR report key: 3092431 · Received May 3, 2013

    Report

    Report Number
    9673241-2013-00144
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 11, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    DRF
    PMA / PMN Number
    K031161
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE IT WAS REPORTED CATHETER COULD NOT BE ADJUSTED. THE ISSUE WAS RESOLVED AFTER THE CATHETER WAS REPLACED. THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT¿S CONSEQUENCE. THIS EVENT WAS REPORTED ON (B)(4) 2013. THIS CATHETER WAS RECEIVED ON (B)(4) 2013 FOR FURTHER ANALYSIS. UPON RECEIPT, THE CATHETER WAS VISUALLY INSPECTED. IT WAS FOUND THAT RING #1 WAS DAMAGED, THE RING WAS FOLDED OVER AND HAD A SHARP EDGE. DUE TO THE CONDITION OF THE CATHETER THIS EVENT IS NOW A MDR REPORTABLE EVENT. UPON RECEIPT, THE DEVICE WAS VISUALLY INSPECTED AND IT WAS FOUND THAT THE RING #1 WAS DAMAGED WITH SHARP EDGE. THIS CONDITION WAS NOT REPORTED IN THE ORIGINAL COMPLAINT. CONTRACTION TEST WAS PERFORMED AND THE CATHETER PASSED THE TEST. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. IN ADDITION, ALL THE CATHETERS ARE INSPECTED FOR VISUAL DAMAGES BEFORE PACKAGING. ON LINE INSPECTIONS ARE IN PLACE TO PREVENT THIS TYPE OF DAMAGE/DEFECT FROM LEAVING THE FACILITY. THE CUSTOMER COMPLAINT REGARDING THE CONTRACTION ISSUE CANNOT BE CONFIRMED.

    Description of Event or Problem · 1

    DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE IT WAS REPORTED CATHETER COULD NOT BE ADJUSTED. THE ISSUE WAS RESOLVED AFTER THE CATHETER WAS REPLACED. THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT'S CONSEQUENCE. THIS EVENT WAS REPORTED ON (B)(4) 2013. THIS CATHETER WAS RECEIVED ON (B)(4) 2013 FOR FURTHER ANALYSIS. UPON RECEIPT, THE CATHETER WAS VISUALLY INSPECTED. IT WAS FOUND THAT RING #1 WAS DAMAGED, THE RING WAS FOLDED OVER AND HAD A SHARP EDGE. DUE TO THE CONDITION OF THE CATHETER THIS EVENT IS NOW A MDR REPORTABLE EVENT. ALERT DATE WAS RESET TO (B)(4) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194903 CATHETER, ELECTRODE RECORDING DRF BIOSENSE WEBSTER, INC. (JUAREZ) D-1237-01-S 15650108L

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR