BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER

    MDR report key: 3230200 · Received July 16, 2013

    Report

    Report Number
    9673241-2013-00232
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 28, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S025
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS HAVE BEEN MADE TO REQUEST FOR THE COMPLAINT PRODUCT TO BE RETURNED FOR ANALYSIS. IT WAS STATED BY THE CUSTOMER THAT THE PRODUCT HAD BEEN DISCARDED. THUS 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

    (B)(4) DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, IT WAS REPORTED ERROR 101 WAS DISPLAYED ON THE GENERATOR. THE CATHETER WAS NOT DETECTED. AFTER TROUBLESHOOTING IT WAS DETERMINED THE ISSUE WAS THE CATHETER. THE PHYSICIAN COULD NOT CONTINUE THE PROCEDURE DUE TO THERE WAS NO MORE CATHETERS AVAILABLE IN THE HOSPITAL. ADDITIONAL INFORMATION PROVIDED STATED THE CASE WAS CANCELLED. THE PHYSICIAN DID NOT THINK THERE WAS ANY POTENTIAL RISK TO THE PATIENT. THE CASE WAS RESCHEDULED. PATIENT WAS UNDER LOCAL ANESTHESIA. TRANSSEPTAL PUNCTURE WAS PERFORMED ON THE PATIENT PRIOR TO THE CASE CANCELLATION. DUE TO THIS, THIS IS NOW A MDR REPORTABLE EVENT. THE RETURNED DEVICE WAS VISUALLY INSPECTED UPON RECEIPT AND IT WAS FOUND THAT THE CONNECTOR HAD GREEN RESIDUES THAT WERE NOT REPORTED AS PART OF THE COMPLAINT. PER THE EVENT, THE CATHETER WAS ATTEMPTED TO BE TESTED FOR EEPROM, CARTO AND CALIBRATION FUNCTIONALITY HOWEVER IT FAILED. IT WAS FOUND THAT THE EEPROM COULD NOT BE READ DURING THE ANALYSIS. THE DEVICE HISTORY RECORD (DHR) WAS REVISED AND NO ANOMALIES WERE FOUND RELATED TO THIS FAILURE MODE. DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. THE CUSTOMER COMPLAINT HAS BEEN VERIFIED.

    Description of Event or Problem · 1

    DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, IT WAS REPORTED ERROR 101 WAS DISPLAYED ON THE GENERATOR. THE CATHETER WAS NOT DETECTED. AFTER TROUBLESHOOTING IT WAS DETERMINED THE ISSUE WAS THE CATHETER. THE PHYSICIAN COULD NOT CONTINUE THE PROCEDURE DUE TO THERE WERE NO MORE CATHETERS AVAILABLE IN THE HOSPITAL. ADDITIONAL INFORMATION PROVIDED STATED THE CASE WAS CANCELLED. THE PHYSICIAN DID NOT THINK THERE WAS ANY POTENTIAL RISK TO THE PATIENT. THE CASE WAS RESCHEDULED. PATIENT WAS UNDER LOCAL ANESTHESIA. TRANSSEPTAL PUNCTURE WAS PERFORMED ON THE PATIENT PRIOR TO THE CASE CANCELLATION. DUE TO THIS, THIS IS NOW A MDR REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328580 THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1317-05-S 15832238L

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR