BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOGA-STAR¿ CARDIOLOGY CATHETER

    MDR report key: 3885046 · Received June 19, 2014

    Report

    Report Number
    2029046-2014-00176
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 22, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    DRF
    PMA / PMN Number
    K954390
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REF. NO: (B)(4) IT WAS REPORTED THAT A PATIENT UNDERWENT AN ENDOCARDIAL STEM CELL INJECTION (CLINICAL STUDY SPONSORED BY (B)(4)) PROCEDURE WITH A NOGASTAR CATHETER AND SUFFERED A CARDIAC TAMPONADE WHICH REQUIRED A PERICARDIOCENTESIS. THE PATIENT¿S MEDICAL HISTORY IS UNKNOWN. A PERFORATION OF THE LEFT VENTRICLE WAS NOTICED AND CONFIRMED BY SURFACE ECHO. A PERICARDIOCENTESIS WAS PERFORMED HOWEVER, THE VOLUME OF FLUID REMOVED WAS UNKNOWN. THERE IS NO FURTHER INFORMATION ABOUT THE HOSPITALIZATION AND IF ANY ADDITIONAL INTERVENTION WAS PERFORMED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AT THE TIME THE COMPLAINT WAS REPORTED. THE RETURNED DEVICE WAS VISUALLY INSPECTED UPON RECEIPT AND THE SHAFT WAS BENT ABOUT 7CM AND 30.2 CM FROM SLEEVE. PER THE EVENT, THE CATHETER WAS TESTED FOR ELECTRICAL PERFORMANCE AND IT WAS FOUND WITHIN SPECIFICATIONS. THE CATHETER WAS ALSO EVALUATED FOR EEPROM, CARTO 3, 4 KHZ AND CALIBRATION FUNCTIONALITY. THE CATHETER WAS RECOGNIZED BY CARTO 3 SYSTEM, NO ERROR MESSAGES WERE DISPLAYED AND THE CATHETER WAS PROPERLY VISUALIZED. EEPROM DATA DEMONSTRATES THE CATHETER WAS PROPERLY CALIBRATED DURING MANUFACTURING. FINALLY, A DEFLECTION TEST WAS PERFORMED AND THE CATHETER PASSED. 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 PERFORATION REMAINS UNKNOWN. THE IFU STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED IN ORDER TO AVOID CARDIAC DAMAGE, PERFORATION OR TAMPONADE.

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. 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. CONCOMITANT PRODUCTS: NOGA SYSTEM; MODEL #: UNKNOWN; SERIAL #: UNKNOWN. NOGASTAR; MODEL #: 120708S; LOT #:15946496M . MYOSTAR; MODEL #: D-1211-19-SI; LOT #:15987367. EXTERNAL REFERENCE PATCH; MODEL #: D-1210-03; LOT #: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ENDOCARDIAL STEM CELL INJECTION ((B)(4) STUDY) PROCEDURE WITH A NOGASTAR CATHETER AND SUFFERED A CARDIAC TAMPONADE WHICH REQUIRED A PERICARDIOCENTESIS. THE PATIENT¿S MEDICAL HISTORY IS UNKNOWN. A PERFORATION OF THE LEFT VENTRICLE WAS NOTICED AND CONFIRMED BY SURFACE ECHO. A PERICARDIOCENTESIS WAS PERFORMED HOWEVER, THE VOLUME OF FLUID REMOVED WAS UNKNOWN. THERE IS NO FURTHER INFORMATION ABOUT THE HOSPITALIZATION AND IF ANY ADDITIONAL INTERVENTION WAS PERFORMED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AT THE TIME THE COMPLAINT WAS REPORTED. THE PHYSICIAN DID NOT PROVIDE A CAUSALITY OPINION FOR THE CAUSE OF THIS ADVERSE EVENT. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. PER 21 CFR, PART 803, THIS COMPLAINT IS REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361713 NOGA-STAR¿ CARDIOLOGY CATHETER CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER, INC (IRWINDALE) 120707S 15970388M

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R