BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONSTELLATION ADVANCED MAPPING CATHETER

    MDR report key: 532488 · Received July 2, 2004

    Report

    Report Number
    2939222-2004-00026
    Event Type
    Other
    Date Received
    July 2, 2004
    Date of Event
    June 10, 2004
    Report Date
    June 10, 2004
    Manufacturer
    EP TECHNOLOGIES, INC.
    Product Code
    MTD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT AN ELECTROPHYSIOLOGY PROCEDURE TO HAVE AN ABLATION FOR ARTRIAL FIBRILLATION. DIAGNOSTIC CATHETERS WERE INSERTED INTO THE CORONARY SINUS (CS) AND THE RIGHT VENTRICLE (RV). AN ACUSON INTRACARDIAC ECHOCARDIOGRAPHIC (ICE) CATHETER WAS INSERTED AND POSITIONED IN THE RIGHT ATRIUM. THE CONSTELLATION DIAGNOSTIC CATHETER WAS INSERTED IN THE LEFT ATRIUM VIA A TRANSSEPTAL PUNCTURE USING A CONVOY SHEATH. USING ICE GUIDANCE, THE PHYSICIAN TARGETED THE CONVOY SHEATH INTO THE LEFT INFERIOR PULMONARY VEIN (LIPV), THEN DEPLOYED THE CONSTELLATION. AS EVIDENCED ON FLUOROSCOPY, THE BASKET DISTAL TIP OF THE CONSTELLATION CATHETER APPEARED TO BE "PINCHED" CIRCUMFERENTIALLY. THE PHYSICIAN REMOVED THE CONSTELLATION FROM THE TARGETED AREA OF THE LIPV AND THEN REPOSITIONED THE SHEATH/CONSTELLATION ASSEMBLY INTO THE LEFT SUPERIOR PULMONARY VEIN. AT THIS POINT, THE PT DEVELOPED BRADYCARDIA WITH A HEART RATE OF 20 BPM WITH NO BLOOD PRESSURE. TREATMENT OF THE EVENT, BELIEVED AT THIS TIME TO BE A VASOVAGAL REACTION, INCLUDED ATROPINE, TEMPORARY PACING, HEPARIN REVERSAL, AND FLUID ADMINISTRATION. PT STABILIZED. HOWEVER, FURTHER ASSESSMENT WITH THE ICE CATHETER, STILL POSITIONED IN THE RIGHT ATRIUM, REVEALED A PERICARDIAL EFFUSION (PRESUMABLY AS A RESULT OF A CATHETER PERFORATION) REQUIRING A PERICARDIALCENTESIS. THE PT APPEARED STABLE WITH A HEART RATE OF 70 BPM AND A BLOOD PRESSURE OF 130/70MM HG. NONETHELESS, A SURGICAL CONSULTATION WAS REQUESTED. THE BLAZER XP CATHETER WAS INSERTED BUT NO ABLATION OCCURRED. RETROSPECTIVELY, THE PERFORATION WAS BELIEVED TO HAVE RESULTED FROM THE CONSTELLATION DEPLOYED IN THE LEFT ATRIAL APPENDAGE RATHER THAN THE TARGETED LIPV AS EVIDENCED BY THE "PINCHED" EFFECT ON THE BASKET DISTAL TIP. IN 06/2004, AN EP TECHNOLOGIES, INC. SALES REP VISITED THE FACILITY AND DETERMINED THE PT HAD NOT REQURIED SURGERY, WAS FINE AND RELEASED THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSTELLATION ADVANCED MAPPING CATHETER ADVANCED DIAGNOSTIC MAPPING CATHETER MTD EP TECHNOLOGIES, INC. 8031 6413712

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| O| R UNK).| ACUSON INTRACARDIAC ECHOCARDIOGRAPHIC (ICE) (MODEL| (MODEL 4500THK2, LOT #6367154),| DIAGNOSTIC EP CATHETERS (MFRS AND MODEL NUMBERS| (MODEL 5676ST, LOT# F10383) AND BLAZER XP CATHETER| NUMBER UNK), CORONARY SINUS AND RIGHT VENTRICLE| EP TECHNOLOGIES, INC. PRODUCTS: CONVOY SHEATH KIT