BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTABLATE¿ IRRIGATION PUMP

    MDR report key: 5082724 · Received September 16, 2015

    Report

    Report Number
    9612355-2015-00044
    Event Type
    Injury
    Date Received
    September 16, 2015
    Date of Event
    August 21, 2015
    Report Date
    August 21, 2015
    Manufacturer
    STOCKERT GMBH
    Product Code
    LPB
    PMA / PMN Number
    P990071/S017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT A PATIENT, UNDERWENT AN ATRIAL FIBRILLATION PROCEDURE WITH A SMARTABLATE¿ IRRIGATION PUMP AND SMART TOUCH CATHETER. DURING THE PROCEDURE IT WAS NOTICED A LOW FLOW IRRIGATION ISSUE. SOON AFTER ST ELEVATION WAS OBSERVED IN THE INFERIOR LEADS WHICH RESOLVED WITHOUT INTERVENTION. AFTER FIVE MINUTES. IT WAS DISCOVERED THAT THE TUBING WAS NOT CONNECTED PROPERLY AND BYPASSED THE SENSOR. THE PATIENT WAS REPORTED FULLY RECOVERED WITH NO NEUROLOGICAL SYMPTOMS AT THE TIME BWI FOLLOWED-UP. REPAIR FOLLOW-UP WAS PERFORMED AND DEVICE WILL BE NOT SHIPPED FOR SERVICE. SERVICE WAS DECLINED. THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES.

    Additional Manufacturer Narrative · 1

    THE HARDWARE INVESTIGATION HAS BEGUN BUT IT HAS NOT BEEN COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. BWI CONCOMITANT PRODUCTS USED: PRODUCT NAME: CARTO® 3 SYSTEM; US CATALOG #: FG540000; SERIAL #: (B)(4). PRODUCT NAME: SMARTABLATE GENERATOR KIT (US); US CATALOG #: M490007; SERIAL #: (B)(4). PRODUCT NAME: SMARTABLATE REMOTE KIT (US); US CATALOG #: UNKNOWN; SERIAL #: (B)(4). PRODUCT NAME: THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER; US CATALOG #: D132705; LOT #: 17225921M. PRODUCT NAME: THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER; US CATALOG #: D132705; LOT #: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT, UNDERWENT AN ATRIAL FIBRILLATION PROCEDURE WITH A SMARTABLATE¿ IRRIGATION PUMP AND DURING THE PROCEDURE LOW FLOW WAS NOT ALLOWED AS WELL AS AN AIR EMBOLUS WAS DISCOVERED AFTER BYPASSING THE SENSOR. ALSO, AN ST ELEVATION WAS OBSERVED IN THE INFERIOR LEADS WHICH RESOLVED AFTER FIVE MINUTES. THE PATIENT'S MEDICAL HISTORY IS UNKNOWN. ONCE PHYSICIAN CONFIRMED STABILITY THE CASE WAS CONTINUED WITH NO OTHER COMPLICATIONS. IT WAS ALSO REPORTED THAT A THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER DISPLAYED AN ERROR 105 (MAGNETIC SENSOR). TROUBLESHOOTING WAS PERFORMED AND WHEN THE CATHETER WAS REPLACED, THE ISSUE WAS RESOLVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION WAS REQUESTED TO CLARIFY THE EVENT AND IT WAS INFORMED THAT PATIENT DIAGNOSIS RELATED TO THIS EVENT IS A POSSIBLE TRANSIENT AIR EMBOLISM. THERE IS NO FURTHER INFORMATION ABOUT THE HOSPITALIZATION AND THE PATIENT DID NOT REQUIRE ANY INTERVENTION. THE PATIENT WAS REPORTED FULLY RECOVERED WITH NO RESIDUAL EFFECTS AT THE TIME BWI FOLLOWED-UP. THE PHYSICIAN'S OPINION REGARDING THE CAUSE OF THIS ADVERSE EVENT IS THAT THIS IS AN AIR EMBOLUS THAT WENT THROUGH THE LONG SHEATH OR THE CATHETER POSSIBLY NOT FLUSHED PROPERLY BY THE STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614275 SMARTABLATE¿ IRRIGATION PUMP CARDIAC ABLATION PERCUTANEOUS CATHETER LPB STOCKERT GMBH M-4900-08

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| O