BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPREME EP CATHETER, 6F, QUADRIPOLAR, CRD

    MDR report key: 2251068 · Received August 31, 2011

    Report

    Report Number
    3005188751-2011-00153
    Event Type
    Injury
    Date Received
    August 31, 2011
    Date of Event
    August 10, 2011
    Report Date
    August 10, 2011
    Manufacturer
    ST. JUDE MEDICAL, AF DIVISION
    Product Code
    DRF
    PMA / PMN Number
    K894500
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE AS THE SERIAL/LOT NUMBER IS UNKNOWN. THE ROOT CAUSE CLASSIFICATION IS CONSISTENT WITH ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE IFU.

    Description of Event or Problem · 1

    THE SAME MFR REPORT AS 2030404-2011-00248, 2030404-2011-00249, 3005188751-2011-00154, 3005188751-2011-00152, 2030404-2011-00247. IT WAS REPORTED THAT DURING A REDO PULMONARY VEIN ISOLATION ABLATION PROCEDURE, THE PATIENT DEVELOPED A PERICARDIAL EFFUSION. THE PHYSICIAN HAD A DIFFICULT TIME WITH THE TRANSSEPTAL PUNCTURE WHICH WAS PERFORMED USING A SJM BRK TRANSSEPTAL NEEDLE AND AN AGILIS INTRODUCER. A SECOND PHYSICIAN ASSISTED WITH THE PUNCTURE USING TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) AND WAS ABLE TO SUCCESSFULLY COMPLETE IT WITHIN 30 MINUTES. DURING THE TEE, THE PATIENT ASPIRATED GASTRIC SECRETIONS, A BRONCHOSCOPY WAS PERFORMED, THE PATIENT STABILIZED AND THE PHYSICIAN CONTINUED THE PROCEDURE. AN INQUIRY STEERABLE CATHETER, AN INQUIRY OPTIMA CATHETER, A SUPREME EP CATHETER AND A COOL PATH DUE CATHETER WERE INSERTED INTO THE PATIENT'S HEART. DURING ABLATION OF THE LEFT INFERIOR PULMONARY VEIN (LIPV) WITH THE COOL PATH DUO CATHETER, THE PATIENT BECAME HYPOTENSIVE AND ULTRASOUND CONFIRMED A 1.3 CM CIRCULAR PERICARDIAL EFFUSION. THE PHYSICIAN ADMINISTERED A SINGLE DOSE OF ADRENALINE, INCREASED INTRAVENOUS FLUIDS AND CONTINUED TO ISOLATE THE PULMONARY VEINS WITHOUT FURTHER INTERVENTION. WHILE ISOLATING THE PULMONARY VEINS, THE COOL PATH DUO CATHETER BECAME UNSTEERABLE. IT WAS REMOVED AND NOTED THAT THE CATHETER COULD NOT MAKE A PROPER CURL. A NEW CATHETER WAS USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER COMPLICATIONS. FOLLOWING THE PROCEDURE, THE PATIENT WAS SENT TO THE INTENSIVE CARE UNIT FOR OBSERVATION. THE PATIENT WAS REPORTEDLY TRANSFERRED OUT OF INTENSIVE CARE ONE NIGHT LATER TO A PERIPHERAL CARE STATION. THERE WERE NO FURTHER CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPREME EP CATHETER, 6F, QUADRIPOLAR, CRD SUPREME EP, 6F, CRD DRF ST. JUDE MEDICAL, AF DIVISION 401442 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention AGILIS NXT, 8.5F, STEERABLE INTRODUCER, SMALL CURL| (B)(4), MODEL 81659, LOT UNKNOWN| MODEL 408309, LOT UNKNOWN| (B)(4), MODEL 88019, LOT# 3243419| INQUIRY STEERABLE CATH., (B)(4)| TRANSSEPTAL NEEDLE, BRK SERIES, ADULT 18GA, 71CM| INQUIRY STEERABLE CATHETER 6F, (B)(4)| COOL PATH DUO, 7F, (B)(4)| MODEL 81107, LOT UNKNOWN| MODEL 407200, LOT UNKNOWN