BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SL 1 INTRODUCER UNK

    MDR report key: 2017647 · Received March 10, 2011

    Report

    Report Number
    3005188751-2011-00031
    Event Type
    Injury
    Date Received
    March 10, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 1, 2011
    Manufacturer
    ST. JUDE MEDICAL, AF DIVISION
    Product Code
    DYB
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES WERE NOT RETURNED FOR EVALUATION. AS CARDIAC PERFORATION IS AN INHERENT RISK ASSOCIATED WITH ANY CARDIAC ABLATION PROCEDURE AND THE PHYSICIAN DOES NOT IMPLICATE ANY SJM PRODUCTS AS THE CAUSE FOR THE REPORTED EVENT, THE CAUSE FOR THE REPORTED EVENT IS UNK. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE AS THE SERIAL/LOT NUMBER IS UNK.

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT 3005188751-2011-00032, 2030404-2011-00072 AND 3005188751-2011-00030. IT WAS REPORTED DURING A PULMONARY VEIN ABLATION PROCEDURE, A PERFORATION OCCURRED. TWENTY MINS PRIOR TO THE EVENT, TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A BRK TRANSSEPTAL NEEDLE, HEPARIN WAS GIVEN, AND THE EN SITE SYSTEM WAS OPTIMIZED FOR GEOMETRY COLLECTION. THE GEOMETRY WAS COLLECTED USING THE AFOCUS II HIGH DENSITY MAPPING CATHETER (LOT K24327). AN SL1 INTRODUCER AND A RESPONSE QUADRIPOLAR CATHETER WERE PLACED IN THE HEART AS WELL. AT THE END OF GEOMETRY COLLECTION, THE PT EXPERIENCED TACHYCARDIA AND BECAME HYPOTENSIVE. INTRACARDIAC ECHOCARDIOGRAPHY VERIFIED A PERICARDIAL EFFUSION. SEVERAL SYRINGES OF BLOOD WERE REMOVED FROM THE PERICARDIAL SPACE AND PROTAMINE WAS GIVEN TO REVERSE THE HEPARIN. THE PROCEDURE WAS ABORTED. THE PT REMAINED UNSTABLE AND WAS TRANSPORTED TO THE OPERATING ROOM FOR SURGICAL INTERVENTION. THE CAUSE AND LOCATION OF THE PERFORATION IS UNK. ADDITIONAL INFO WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SL 1 INTRODUCER UNK SL 1 INTRODUCER UNK DYB ST. JUDE MEDICAL, AF DIVISION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR ENSITE SYSTEM| RESPONSE QUADRIPOLAR CATHETER: (MODEL/LOT UNKNOWN)| MODEL 87008, LOT K24327| AFOCUS II HIGH DENSITY MAPPING CATHETER| BRK TRANSSEPTAL NEEDLE: (MODEL/LOT UNKNOWN)