BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER

    MDR report key: 2771788 · Received October 4, 2012

    Report

    Report Number
    9673241-2012-00280
    Event Type
    Injury
    Date Received
    October 4, 2012
    Date of Event
    September 14, 2012
    Report Date
    September 14, 2012
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S025
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONCOMITANT PRODUCTS : CARTO 3 MODEL # M-4800-01, SERIAL # (B)(4), STOCKERT MODEL # M-5463-01, SERIAL # (B)(4). COOLFLOW PUMP MODEL # M-5491-02, SERIAL # (B)(4). SOUNDSTAR MODEL # M-5723-05, LOT # UNKNOWN. (B)(4).

    Additional Manufacturer Narrative · 1

    AFTER MULTIPLE FOLLOW-UPS TO RETRIEVE THE CATHETER, NO CATHETER WAS RETURNED. THEREFORE NO EVALUATION WAS PERFORMED.THE DEVICE HISTORY RECORD WAS REVIEWED, IT WAS IDENTIFIED THAT 2 PIECES WERE SCRAPED; HOWEVER DHR SHOWS THESE PIECES WERE IDENTIFIED DURING THE PROCESS PRIOR THE FINAL INSPECTION STAGE AND DOCUMENTATION SHOWS THE SCRAP OF THESE PIECES EXIST. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICES WERE MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ISCHEMIC VT ABLATION OF THE LEFT VENTRICLE AFTER ONE LESION WAS DELIVERED, THE PATIENT'S BLOOD PRESSURE DROPPED AND MD SUSPECTED THE PATIENT HAD A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED, BUT NO FLUID WAS FOUND IN THE PERICARDIAL SPACE. IT'S REPORTED THAT AN ECHO WAS PERFORMED AT THAT TIME AND A PLEURAL EFFUSION WAS FOUND. A CHEST TUBE WAS INSERTED WITH A REPORTED 2 LITTERS FLUID DRAINED AND THE PROCEDURE WAS ABANDONED. THE PHYSICIAN'S OPINION REGARDING THE CAUSALITY OF THE PERFORATION WAS HIGH ATRIAL PRESSURES. THE PATIENT IS STABLE AT THIS TIME AND REQUIRED HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1317-02-S 15557718L

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R