BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXCATH ADVANCE STEERABLE SHEATH

    MDR report key: 6128972 · Received November 28, 2016

    Report

    Report Number
    3002648230-2016-00501
    Event Type
    Malfunction
    Date Received
    November 28, 2016
    Date of Event
    November 8, 2016
    Report Date
    November 8, 2016
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    DRA
    PMA / PMN Number
    K123591
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DATA FILES WERE RETURNED AND ANALYZED. THE DATA FILES DID NOT SHOW SYSTEM NOTICES OR ISSUES FOR THE DATE OF THE EVENT.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE PATIENT EXPERIENCED PAIN. THE PATIENT¿S BLOOD PRESSURE WAS OBSERVED WITH NO CONCERNS AND AN ADDITIONAL BOLUS OF FENTANYL AND HEPARIN WERE GIVEN. AT THE END OF THE ABLATION, THE PATIENT¿S BLOOD PRESSURE HAD DECREASED; IT WAS NOTED THAT, ¿THE RANGE OF THE VALUES WERE SEEN BEFORE THE FIRST APPLICATION¿. THE PROCEDURE WAS CONTINUED UNTIL THE PATIENT¿S BLOOD PRESSURE COULD NOT BE MEASURED NON-INVASIVELY. THE PHYSICIAN REPORTED, ¿NO INVASIVE BLOOD PRESSURE MONITORING WAS IN PLACE, AND AT THIS STAGE AN ARTERIAL CANNULATION WAS NOT POSSIBLE¿. AN X-RAY WAS PERFORMED AND AN OPAQUE, DILATED PERICARDIAL SPACE WAS OBSERVED AND A CARDIAC TAMPONADE WAS SUSPECTED. AN EMERGENCY ECHOCARDIOGRAM WAS PERFORMED AND THE CARDIAC TAMPONADE WAS CONFIRMED. PROTAMIN WAS ADMINISTERED AND AN EMERGENCY PERICARDIAL PUNCTURE WAS CONDUCTED. A DRAIN WAS INSERTED AND BLOOD WAS EXTRACTED. THE PATIENT¿S BLOOD PRESSURE IMPROVED SLIGHTLY; HOWEVER, THE ECG REVEALED THAT THE PERICARDIAL EFFUSION HAD NOT RESOLVED. THE EMERGENCY CARDIAC SURGICAL TEAM WAS NOTIFIED AND A DECISION TO PERFORM AN EMERGENCY STERNOTOMY WAS PERFORMED. IT WAS NOTED THAT MECHANICAL RESUSCITATION WAS REQUIRED FOR APPROXIMATELY FIVE MINUTES DUE TO PROGRESSIVE BRADYCARDIA UNTIL THE ARRIVAL OF THE SURGICAL TEAM. OPEN HEART SURGERY WAS CONDUCTED AND THE PERICARDIAL EFFUSION WAS DRAINED AND A CARDIO-PULMONARY BYPASS WAS INSTALLED. EXPLORATION OF THE HEART REVEALED A PERFORATION TO THE LEFT SUPERIOR PULMONARY VEIN (LSPV), WHICH WAS CLOSED BY THE CARDIAC SURGEON. HOWEVER, AN INTERMITTENT ST-ELEVATION WAS OBSERVED. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS CONDUCTED THAT OBSERVED NO REGIONAL WALL MOTION ABNORMALITIES, BUT THERE WAS A SIGNIFICANT AMOUNT OF AIR IN THE LEFT PULMONARY VEIN (LPV). A LARGE PART OF THE AIR WAS RELEASED THROUGH THE VENTRICULAR WALL AND THE PATIENT¿S ST SEGMENT ELEVATION RESOLVED. THE PATIENT WAS DISCONNECTED FROM THE CARDIOPULMONARY BYPASS AND THE CHEST WAS CLOSED. HOWEVER, SEVERE RIGHT-HEART FAILURE OCCURRED, REQUIRING EMERGENT RE-OPENING OF THE CHEST AND RE-INSTALLATION OF THE CARDIOPULMONARY BYPASS. AFTER CARDIOPULMONARY BYPASS AND CONTINUOUS SEVERELY IMPAIRED BI-VENTRICULAR FUNCTION, IT WAS DECIDED TO LEAVE THE CHEST OPEN AND TO INSTALL AN EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). THE PATIENT WAS THEN TRANSFERRED TO THE SURGICAL INTENSIVE CARE UNIT WITH THE ECMO IN PLACE AND HEMODYNAMICALLY STABLE. IT WAS FURTHER REPORTED THAT THE PATIENT WAS STILL IN RECOVERY FIVE DAYS AFTER THE PROCEDURE AND THE PATIENT¿S CHEST REMAINS OPEN. THE PHYSICIAN REPORTED THAT, ¿WEANING OF THE ECMO IS COMPLETED HALF WAY AND THE ECMO CAN HOPEFULLY BE REMOVED SOON¿. THE PATIENT¿S OTHER ORGANS WERE STABLE AND NEUROLOGICALLY THE PATIENT HAS OPENED THEIR EYES AND WAS FOLLOWING COMMANDS AND MOVING ALL EXTREMITIES. THE PHYSICIAN ALSO REPORTED THAT THE PATIENT HAD BEEN TAKEN OFF THE VENTILATION AND ECMO. THE PATIENT HAS NO PERMANENT INJURY AND IS CARDIOLOGICALLY AND NEUROLOGICALLY IN GOOD SHAPE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779516 FLEXCATH ADVANCE STEERABLE SHEATH CATHETER, STEERABLE DRA MEDTRONIC CRYOCATH LP 4FC12 01215

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| L| R 4FC12, (B)(4)