BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELLAMAP ORION¿

    MDR report key: 5444197 · Received February 18, 2016

    Report

    Report Number
    2134265-2016-00608
    Event Type
    Injury
    Date Received
    February 18, 2016
    Report Date
    January 19, 2016
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    DRF
    PMA / PMN Number
    K122461
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: DEVICE BRAND NAME CORRECTED FROM RHYTHMIA¿ MAPPING SYSTEM TO INTELLAMAP ORION¿. COMMON DEVICE NAME, CORRECTED FROM COMPUTER, DIAGNOSTIC, PROGRAMMABLE TO CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING. PRODUCT CODE CORRECTED FROM DQK TO DRF. MANUFACTURER NAME CORRECTED FROM BOSTON SCIENTIFIC (B)(4). UPN AND CATALOG/MODEL # CORRECTED FROM UNKNOWN TO M004RC64S0 AND RC64S. MFG SITE NAME CORRECTED FROM BOSTON SCIENTIFIC (B)(4). PMA# OR 510K# CORRECTED FROM K130750 TO K122461. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS: 2134265-2016-01888. IT WAS FURTHER REPORTED THAT DURING THE PROCEDURE, POLARIS X STEERABLE DECAPOLAR MAPPING CATHETERS, BLAZER OPEN-IRRIGATED ABLATION CATHETER AND INTELLAMAP ORION¿ MAPPING CATHETER WAS USED. DURING RECOVERY, THE PATIENT WAS FOUND TO HAVE A VARIABLE BLOOD PRESSURE, MILD CHEST PAIN AND AN ECHOCARDIOGRAM FOUND A SMALL TAMPONADE. THE CAUSE OF THE TAMPONADE IS UNKNOWN THOUGH THE PATIENT HAD SOME VARIANTS IN ANATOMY. IT WAS NOTED THAT THE PLACEMENT OF POLARIS X CATHETER WAS VERY DIFFICULT. IT WAS NOTED THAT THERE WAS NO ISSUE WITH THE USE OF THE BLAZER OI OR THE ORION CATHETER AND NOT ANY ALLEGED ISSUE WITH THE RHYTHMIA SYSTEM. THE PATIENT¿S SYMPTOMS WERE RESOLVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CARDIAC TAMPONADE OCCURRED. DURING SUPRAVENTRICULAR TACHYCARDIA - HIGH RIGHT ATRIAL TACHYCARDIA PROCEDURE, ARRHYTHMIA¿ MAPPING SYSTEM WAS USED. POST-PROCEDURE, THE PATIENT WAS FOUND TO HAVE A TAMPONADE WHICH REQUIRED IMMEDIATE DRAINING. IT IS UNKNOWN IF IT WAS RELATED TO THE REPORTED PRODUCT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100920 INTELLAMAP ORION¿ CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BOSTON SCIENTIFIC - COSTA RICA (COYOL) M004RC64S0

    Patients

    Seq Age Sex Outcome Treatment
    1 Other