BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASSOSTAR¿ CIRCULAR MAPPING CATHETER

    MDR report key: 14599695 · Received June 5, 2022

    Report

    Report Number
    2029046-2022-01202
    Event Type
    Injury
    Date Received
    June 5, 2022
    Date of Event
    May 12, 2022
    Report Date
    June 14, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON 25-MAY-2023, THE PRODUCT INVESTIGATION WAS COMPLETED AS THE COMPLAINT DEVICE WAS NOT RETURNED. SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. MANUFACTURER RECORD EVALUATION CANNOT BE CONDUCTED BECAUSE THE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 62-YEAR-OLD MALE PATIENT (104 KGS) UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH, MEDIUM. THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS, SURGICAL INTERVENTION AND PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT AFTER PERFORMING A TRANSSEPTAL PROCEDURE THE PHYSICIAN WAS MAPPING IN THE LEFT ATRIUM WHEN THE LASSO CATHETER CAME BACK INTO THE RIGHT ATRIUM. THE PHYSICIAN WAS TRYING TO GET THE SHEATH (BAYLIS) AND THE LASSO CATHETER TO THE LEFT ATRIUM THROUGH THE SAME TRANSSEPTAL PUNCTURE. THE VIZIGO AND THE ABLATION CATHETER WERE IN THE LEFT ATRIUM DURING THIS TIME. THE PHYSICIAN WENT TO GO CHECK VIA INTRACARDIAC ECHO USING THE SOUNDSTAR CATHETER AND DISCOVERED A PERICARDIAL EFFUSION. THE MEDICAL TEAM CONFIRMED THAT THE "PHYSICIAN THINKS THEY MAY HAVE COME BACK INTO THE LEFT ATRIUM AT A BAD ANGLE". A PERICARDIOCENTESIS WAS PERFORMED, AND FLUID WAS BEING REMOVED BUT THE PHYSICIAN WAS "FEEDING" IT BACK TO THE PATIENT. AN UNKNOWN AMOUNT OF FLUID WAS REMOVED. THE PATIENT WAS STABLE, AND THE BLOOD PRESSURE WAS BEING TREATED BY ANESTHESIA. THE DRAINAGE TUBE WAS LEFT IN PLACE. THE CARDIOTHORACIC SURGEON AND THE OR TEAM CAME INTO THE EP LAB AND STARTED PREPPING FOR INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME AS THE BWI TEAM HAD TO LEAVE THE ROOM. THE REPROCESSED CS DOES NOT BELONG TO STERILMED, IT BELONGS TO INNOVATIVE HEALTH. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT IS THAT IT WAS THE PROCEDURE. THE PHYSICIAN¿S THINKS THAT WHEN HE WAS PUTTING HIS VERSA CROSS SHEATH BACK TRANSEPTAL INTO THE LEFT ATRIUM HE THINKS HE PERFORATED. PERICARDIOCENTESIS WAS PROVIDED AS INTERVENTION AND THEN THE PATIENT WAS BEING PREPPED FOR CV SURGERY. THE PATIENT OUTCOME OF THE ADVERSE EVENT WAS IMPROVED; THEY WERE STABLE WHEN THE BWI COMPANY REPRESENTATIVE LEFT WHILE THEY WERE GETTING READY FOR SURGERY. THE PATIENT DID REQUIRE EXTENDED HOSPITALIZATION BECAUSE OF THE ADVERSE EVENT TO BE MONITORED AFTER SURGERY. GENERATOR INFORMATION: REF: (B)(4)/ SN: (B)(4). A BAYLIS VERSACROSS TRANSSEPTAL NEEDLE WAS USED. THERE WAS NO EVIDENCE OF STEAM POP AS NO ABLATION WAS PERFORMED. AN IRRIGATED CATHETER WAS USED IN THE EVENT, STANDARD LOW FLOW SETTINGS 2ML WERE USED. CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. THEY NEVER ABLATED SO THE WAS NOT PUMP SWITCHING FROM ¿LOW¿ TO ¿HIGH¿ FLOW DURING ABLATION. NO PARAMETERS FOR STABILITY WERE USED. RESPIRATORY GATING ADDITIONAL FILTER WAS USED WITH THE VISITAG. TAG INDEX COLOR OPTION WAS USED PROSPECTIVELY. GRAPH, DASHBOARD, VECTOR, AND VISITAG FORCE VISUALIZATION FEATURES WERE USED. THE LASSO INFORMATION IS NOT AVAILABLE DUE TO THE SURGICAL TEAM COMING IN TO SCRUB IN. THE LASSO WAS USED THROUGH THE BAYLIS SHEATH. SINCE THE EVENT IS LIFE THREATENING AND IT MIGHT RESULT IN PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE; OR IT COULD REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, IT IS TO BE CONSIDERED SERIOUS AND MDR-REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2411948 LASSOSTAR¿ CIRCULAR MAPPING CATHETER CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Life Threatening| R| H BAYLIS VERSACROSS NEEDLE.| CARTO 3 SYSTEM.| CARTO VISITAG MODULE.| SMARTABLATE GENERATOR.| SOUNDSTAR ECO CATHETER.| THERMOCOOL SMARTTOUCH.| UNSPECIFIED CS CATHETER.