BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER

    MDR report key: 7542829 · Received May 24, 2018

    Report

    Report Number
    2029046-2018-01595
    Event Type
    Injury
    Date Received
    May 24, 2018
    Date of Event
    May 2, 2018
    Report Date
    May 2, 2018
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    MTD
    UDI-DI
    10846835012255
    PMA / PMN Number
    K123837
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: IT WAS REPORTED THAT A FEMALE PATIENT, IN HER 80S, UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS AND SURGICAL INTERVENTION. DURING LEFT ATRIAL MAPPING WITH THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER, THE PATIENT SUDDENLY BECAME HYPOTENSIVE AND A SIGNIFICANT PERICARDIAL EFFUSION WAS DETECTED VIA INTRACARDIAC ECHOCARDIOGRAPHY (ICE). PERICARDIOCENTESIS YIELDED A LARGE VOLUME (UNSPECIFIED) OF BLOOD/FLUID. PATIENT WAS IN UNSTABLE CONDITION AND THE CARDIOTHORACIC SURGEON WAS CONSULTED. OPEN HEART SURGERY WAS PERFORMED TO REPAIR THE PERFORATION NEAR THE LEFT ATRIAL APPENDAGE (LAA). PATIENT WAS REPORTED TO BE IN STABLE CONDITION POSTOPERATIVELY. PATIENT REMAINED IN THE HOSPITAL FOR AN UNSPECIFIED PERIOD OF TIME. THE DEVICE WAS VISUALLY INSPECTED AND IT WAS FOUND IN GOOD CONDITIONS. THE MAGNETIC SENSOR WAS TESTED ON CARTO AND THE CATHETER WAS PROPERLY VISUALIZED AND NO ERRORS WERE OBSERVED. THEN, ELECTRICAL TEST WAS PERFORMED ON THE CATHETER AND IT WAS FOUND WITHIN SPECIFICATIONS. NO ELECTRICAL MALFUNCTION WAS OBSERVED. THEN, THE IRRIGATION AND DEFLECTION TEST WERE PERFORMED AND IT WAS FOUND WITHIN SPECIFICATIONS, THE CATHETER WAS IRRIGATING AND DEFLECTING CORRECTLY. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. THE CATHETER PASSED ALL SPECIFICATIONS. THE ROOT CAUSE OF THE ADVERSE EVENT REMAINS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED TO AVOID CARDIAC DAMAGE, PERFORATION OR TAMPONADE. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    THE BWI FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. THE DEVICE HISTORY RECORD (DHR) FOR THE LOT NUMBER 30025496L HAS BEEN REVIEWED AND IT WAS VERIFIED THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATIONS AND PROCEDURES. CONCOMITANT PRODUCTS: CARTO 3 SYSTEM , US CATALOG #: FG540000, SERIAL (B)(4). NON-BIOSENSE WEBSTER, INC. PRODUCT: COOK MEDICAL TRANSSEPTAL NEEDLE. NON-BIOSENSE WEBSTER, INC. PRODUCT: ST. JUDE MEDICAL SR0 SHEATH. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT, IN HER 80S, UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS AND SURGICAL INTERVENTION. DURING LEFT ATRIAL MAPPING WITH THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER, THE PATIENT SUDDENLY BECAME HYPOTENSIVE AND A SIGNIFICANT PERICARDIAL EFFUSION WAS DETECTED VIA INTRACARDIAC ECHOCARDIOGRAPHY (ICE). PERICARDIOCENTESIS YIELDED A LARGE VOLUME (UNSPECIFIED) OF BLOOD/FLUID. PATIENT WAS IN UNSTABLE CONDITION AND THE CARDIOTHORACIC SURGEON WAS CONSULTED. OPEN HEART SURGERY WAS PERFORMED TO REPAIR THE PERFORATION NEAR THE LEFT ATRIAL APPENDAGE (LAA). PATIENT WAS REPORTED TO BE IN STABLE CONDITION POSTOPERATIVELY. PATIENT REMAINED IN THE HOSPITAL FOR AN UNSPECIFIED PERIOD OF TIME. FACTORS CITED THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT INCLUDE THE PATIENT¿S AGE. PHYSICIAN DID NOT PROVIDE A CAUSALITY OPINION. IT WAS NOTED THAT IT IS BELIEVED THAT THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER WAS RESPONSIBLE FOR THE INJURY. THERE WERE NO ISSUES OR ERRORS REPORTED ON ANY BIOSENSE WEBSTER, INC. PRODUCTS OR EQUIPMENT DURING THE PROCEDURE. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A COOK MEDICAL TRANSSEPTAL NEEDLE AND A ST. JUDE MEDICAL SR0 SHEATH. THERE IS NO INFORMATION REGARDING GENERATOR PARAMETERS, GENERATOR SETTINGS, POWER TITRATION, OVERALL ABLATION TIME AT THE SITE OF INJURY, OR LAST ABLATION CYCLE TIME AT THE SITE OF INJURY, AS NO ABLATION WAS PERFORMED. THERE IS NO INFORMATION REGARDING IRRIGATED CATHETER FLOW SETTING. PATIENT RECEIVED ANTICOAGULANT DURING THE PROCEDURE WITH ACTIVATED CLOTTING TIME (ACT) OF 333 SECONDS AT THE FIRST CHECK AFTER HEPARIN WAS STARTED AND AT THE TIME OF THE ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383284 PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD BIOSENSE WEBSTER INC 30025496L 10846835012255

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R