BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUSON

    MDR report key: 5793008 · Received July 13, 2016

    Report

    Report Number
    3009498591-2016-00194
    Event Type
    Malfunction
    Date Received
    July 13, 2016
    Date of Event
    October 4, 2013
    Report Date
    July 26, 2016
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    OBJ
    PMA / PMN Number
    K140959
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT WHICH IS BEING RE-SUBMITTED PER FDA'S REQUEST AS THE ORIGINAL SUPPLEMENTAL MDR (MFR#3009498591-2016-00194) SUBMITTED IN 2016 DID NOT GO THROUGH CORRECTLY. THE TYPE OF REPORT SECTION G7 WAS MISKENLY MARKED AS "INITIAL", INSTEAD OF FOLLOW-UP#1. THIS MDR IS THE RESULT OF A RETROSPECTIVE REVIEW OF COMPLAINTS FOR THE PURPOSE OF IDENTIFYING CONCOMITANT DEVICES. THE REPORTED EVENT DESCRIBES SIDE EFFECTS FROM THE PROCEDURE OR PATIENT SYMPTOMS DUE TO THEIR CONDITION. THIS PRODUCT IS CONSIDERED A CONCOMITANT DEVICE AND DID NOT CONTRIBUTE TO THE REPORTED EVENT. CORRECTIONS MADE TO FOLLOWING SECTIONS: D9, G1, G3, G7, H3, H6, H10.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE PATIENT INFORMATION (SEE SECTION A1,2,3,4), UPDATE THE OUTCOMES ATTRIBUTED TO ADVERSE EVENTS (SEE SECTION B2), PROVIDE ADDITIONAL EVENT INFORMATION (SEE SECTION B5, B7), CORRECT THE COMMON DEVICE NAME AND DEVICE PROCODE (SEE SECTION D2), UPDATE THE INITIAL REPORTER INFORMATION (SEE SECTION E1), CORRECT THE SPELLING OF THE MANUFACTURER'S CITY (SEE SECTION G2), UPDATE THE REPORT SOURCE (SEE SECTION G3), PROVIDE THE PMA/510(K) INFORMATION (SEE SECTIONG5), PROVIDE ADDITIONAL PATIENT CODE (SEE SECTIONH6), AND TO PROVIDE THE EVALUATION RESULTS (SEE SECTION H10). THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO PHYSICAL DAMAGE WAS OBSERVED. AN ACOUSTIC TEST WAS PERFORMED AND THE DEVICE PASSED.

    Description of Event or Problem · 0

    THIS IS A SUPPLEMENTAL REPORT WHICH IS BEING RE-SUBMITTED PER FDA'S REQUEST AS THE ORIGINAL SUPPLEMENTAL MDR (MFR#3009498591-2016-00194) SUBMITTED IN 2016 DID NOT GO THROUGH CORRECTLY.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE PATIENT WAS IN THE HOSPITAL FOR A REPEAT ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE. PRIOR TO THE PROCEDURE, THE PATIENT WAS GIVEN AN ANTICOAGULANT. THE PHYSICIAN ACHIEVED A DIFFICULT TRANSEPTAL ACCESS WITH TWO SEPARATE SHEATHS. WITH BOTH SHEATHS ACROSS, THE PHYSICIAN BEGAN MAPPING WITH A LASSO CATHETER ON THE UPPER LEFT VEIN AND WHICH AT THIS POINT, A SLIGHT DROP IN THE PATIENT'S BLOOD PRESSURE WAS NOTED. THIS WAS ATTRIBUTED TO THE ANESTHESIA SO THE PHYSICIAN PROCEEDED TO BURN THE TISSUE ON THE UPPER LEFT VEIN. AT THIS POINT, THE PATIENT'S BLOOD PRESSURE CONTINUED TO DROP. AN INTRACARDIAL ECHOCARDIOGRAPHY (ICE) SHOWED PERICARDIAL EFFUSION. THE EFFUSION BECAME MODERATE BUT ECHO SHOWED SEVERE EFFUSION. A PERICARDIOCENTESIS AND SURGICAL PERICARDIAL WINDOW WERE PERFORMED TO ALLEVIATE THE BLEEDING. THE PHYSICIAN REMOVED 800 CC'S OF FLUID FROM THE PERICARDIAL CAVITY. THE INTENDED PROCEDURE WAS REPORTEDLY ABANDONED FOR PATIENT SAFETY. THE PATIENT WAS IMMEDIATELY TRANSFERRED TO SURGERY FOR REPAIR. IT WAS FURTHER REPORTED THAT THE PATIENT MADE A FULL RECOVERY AFTER AN EXTENDED HOSPITAL STAY. IT WAS REPORTED THAT THE PHYSICIAN THOUGHT THAT THE EVENT WAS ATTRIBUTABLE TO THE TRANSEPTAL PUNCTURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    THIS MDR IS THE RESULT OF A RETROSPECTIVE REVIEW OF COMPLAINTS FOR THE PURPOSE OF IDENTIFYING CONCOMITANT DEVICES. THE REPORTED EVENT DESCRIBES SIDE EFFECTS FROM THE PROCEDURE OR PATIENT SYMPTOMS DUE TO THEIR CONDITION. THIS PRODUCT IS CONSIDERED A CONCOMITANT DEVICE AND DID NOT CONTRIBUTE TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE MAPPING THE LEFT ATRIUM THE PATIENT BECAME HYPOTENSIVE. THE HYPOTENSION WAS TREATED WITH MEDICATION AND ABLATION WAS STARTED. THE PATIENT BECAME HYPOTENSIVE AGAIN. ECHOCARDIOGRAPHY SHOWED A PERICARDIAL EFFUSION. THE PROCEDURE WAS STOPPED CATHETERS WERE WITHDRAWN AND ANTI-COAGULATION WAS REVERSED. A PERICARDIOCENTESIS WAS PERFORMED AND MORE THAN 800 CC'S OF FLUID WAS REMOVED FROM THE PERICARDIAL SPACE. THE PATIENT WAS NOT STABLE AT THE TIME OF THE CALL AND WAS BEING TRANSFERRED TO SURGERY. BWI PRODUCTS IN USE WERE: CARTO 3 10248, STOCKERT ST-0852, COOLFLOW PUMP 03618, NAVISTAR D131804, LASSO CATHETER D134301, AND ACUNAV 10135936. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443113 ACUSON ULTRASOUND CATHETER OBJ SIEMENS MEDICAL SOLUTIONS USA, INC. ACUNAV 8F-90

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Hospitalization| L| O