BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALO XP ELECTROPHYSIOLOGY CATHETER WITH AUTO ID

    MDR report key: 2615353 · Received June 13, 2012

    Report

    Report Number
    9673241-2012-00121
    Event Type
    Malfunction
    Date Received
    June 13, 2012
    Date of Event
    May 23, 2012
    Report Date
    May 23, 2012
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    DRF
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS HAVE BEEN MADE TO REQUEST FOR THE COMPLAINT PRODUCT TO BE RETURNED FOR ANALYSIS. PRODUCT WAS NOT RETURNED FOR INVESTIGATION AS INITIALLY REPORTED.THE DEVICE HISTORY RECORD WAS REVIEWED, AND WAS VERIFIED THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES.(B)(4).

    Additional Manufacturer Narrative · 1

    THE PMA / 510(K)#: K953663. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN A-FIB PROCEDURE, THE TIP OF THE HALO XP CATHETER WAS STATED TO BE DETACHED AND NEEDED TO BE RETRIEVED FROM THE PATIENT. THERE WAS NO PATIENT INJURY. UPON FURTHER FOLLOW-UP REGARDING THE EVENT, IT WAS CLARIFIED BY THE BWI REPRESENTATIVE THAT THE TIP OF THE CATHETER DID NOT DETACH AS INITIALLY REPORTED. THE PULLER WIRES SEEMED TO HAVE MALFUNCTIONED AND THE CATHETER HAD TO BE RETRIEVED WITH A SNARE DEVICE. THERE WAS NO INJURY TO THE PATIENT. THEREFORE FURTHER ATTEMPTS WERE MADE TO THE CUSTOMER TO ASK DETAILS AND SPECIFICS OF THE COMPLAINT. HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HALO XP ELECTROPHYSIOLOGY CATHETER WITH AUTO ID CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER, INC. (JUAREZ) D-1160-43-S 15596799L

    Patients

    Seq Age Sex Outcome Treatment
    1