BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER

    MDR report key: 9282215 · Received November 5, 2019

    Report

    Report Number
    2029046-2019-03833
    Event Type
    Injury
    Date Received
    November 5, 2019
    Date of Event
    October 14, 2019
    Report Date
    October 14, 2019
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OBJ
    UDI-DI
    10846835008838
    PMA / PMN Number
    K112050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INITIALLY, IT WAS REPORTED THAT A 67-YEAR-OLD MALE PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING THE PROCEDURE, THE PATIENT DEVELOPED A PERICARDIAL EFFUSION AFTER THE ST. JUDE/ABBOTT MEDICAL SL1 SHEATH, WHICH WAS IN LEFT ATRIUM, WAS EXCHANGED FOR ST. JUDE/ABBOTT MEDICAL 8.5 FRENCH AGILIS SHEATH. PERICARDIOCENTESIS WAS PERFORMED BY INTERVENTIONAL CARDIOLOGIST, AND 600 CC OF FLUID WAS REMOVED FROM THE PERICARDIAL SPACE. HOWEVER, BLEEDING CONTINUED AFTER DRAINAGE. A CARDIOTHORACIC SURGEON WAS CONSULTED FOR SURGICAL REPAIR OF PERFORATION. TWO DAYS OF HOSPITALIZATION WAS REQUIRED AS A RESULT OF THE ADVERSE EVENT. PATIENT¿S OUTCOME IS FULLY RECOVERED. THE PHYSICIAN OPINION ON CAUSALITY OF THE EVENT IS THAT THIS WAS PROCEDURE RELATED. NO ERROR MESSAGES ON BIOSENSE WEBSTER, INC. EQUIPMENT WAS REPORTED. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A ST. JUDE/ABBOTT MEDICAL 8.5 FRENCH AGILIS SHEATH, ST. JUDE/ABBOTT MEDICAL SL1 SHEATH, AND A ST. JUDE/ABBOTT MEDICAL BRK1 TRANSSEPTAL NEEDLE. NO ABLATION CATHETER WAS USED DURING THE PROCEDURE. AFTER FURTHER REVIEW ON NOVEMBER 21, 2019, IT WAS DETERMINED THAT THIS COMPLAINT WAS SUBMITTED IN ERROR AS THE EVENT IS NOT MDR REPORTABLE. IN THIS EVENT OF CARDIAC TAMPONADE, THE EFFUSION WAS NOTED AFTER TRANSSEPTAL PROCEDURE AND WITH TRANSITION TO A SECOND SHEATH. ALTHOUGH ULTRASOUND WAS USED AT THE TIME, THERE IS NO INDICATION THAT THE EFFUSION WAS CAUSED BY THE PRODUCT. THIS PRODUCT SHOULD BE CONSIDERED CONCOMITANT GIVEN THE TIMING OF EFFUSION SEEMED TO BE DIRECTLY RELATED TO TRANSSEPTAL PROCEDURE AND EXCHANGE OF SHEATH. HOWEVER, SINCE IT HAS ALREADY BEEN REPORTED TO FDA, ANY ADDITIONAL UPDATES RECEIVED WILL CONTINUE TO BE REPORTED. PATIENT CODE OF ¿NO CODE AVAILABLE¿ REPRESENTS ¿SURGICAL INTERVENTION¿. THIS HAS BEEN ADDED TO MATCH THE EVENT DESCRIPTION. ON NOVEMBER 27, 2019, THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION, AND IT WAS NOTED THAT UPON INITIAL VISUAL INSPECTION, THERE WAS NO DAMAGES OR ANOMALIES THAT WERE OBSERVED. 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. MANUFACTURER'S REFERENCE # (B)(4).

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY- IT WAS REPORTED THAT A 67-YEAR-OLD MALE PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING THE PROCEDURE, THE PATIENT DEVELOPED A PERICARDIAL EFFUSION AFTER THE ST. JUDE/ABBOTT MEDICAL SL1 SHEATH, WHICH WAS IN LEFT ATRIUM, WAS EXCHANGED FOR ST. JUDE/ABBOTT MEDICAL 8.5 FRENCH AGILIS SHEATH. PERICARDIOCENTESIS WAS PERFORMED BY INTERVENTIONAL CARDIOLOGIST, AND 600 CC OF FLUID WAS REMOVED FROM THE PERICARDIAL SPACE. HOWEVER, BLEEDING CONTINUED AFTER DRAINAGE. A CARDIOTHORACIC SURGEON WAS CONSULTED FOR SURGICAL REPAIR OF PERFORATION. TWO DAYS OF HOSPITALIZATION WAS REQUIRED AS A RESULT OF THE ADVERSE EVENT. PATIENT¿S OUTCOME IS FULLY RECOVERED. THE PHYSICIAN OPINION ON CAUSALITY OF THE EVENT IS THAT THIS WAS PROCEDURE RELATED. UPON RECEIPT, THE CATHETER WAS VISUALLY INSPECTED, AND NO DAMAGE WERE FOUND. ADDITIONAL TESTING WAS PERFORMED ON CARTO, DEFLECTION TEST, TRANSDUCER AND COIL DISCONNECTION TESTS AND THE CATHETER PASSED ALL SPECIFICATION. THE DEVICE IS WORKING PROPERLY. CUSTOMER COMPLAINT WAS NOT CONFIRMED. THERE WAS NO DEVICE FAILURE. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND IT WAS VERIFIED THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. MANUFACTURER'S REFERENCE # (B)(4).

    Additional Manufacturer Narrative · 1

    SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. DEVICE HISTORY RECORD (DHR) WAS REVIEWED. IT WAS VERIFIED THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. MANUFACTURER'S REFERENCE # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6)-YEAR-OLD MALE PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING THE PROCEDURE, THE PATIENT DEVELOPED A PERICARDIAL EFFUSION AFTER THE ST. JUDE/ABBOTT MEDICAL SL1 SHEATH, WHICH WAS IN LEFT ATRIUM, WAS EXCHANGED FOR ST. JUDE/ABBOTT MEDICAL 8.5 FRENCH AGILIS SHEATH. PERICARDIOCENTESIS WAS PERFORMED BY INTERVENTIONAL CARDIOLOGIST, AND 600 CC OF FLUID WAS REMOVED FROM THE PERICARDIAL SPACE. HOWEVER, BLEEDING CONTINUED AFTER DRAINAGE. A CARDIOTHORACIC SURGEON WAS CONSULTED FOR SURGICAL REPAIR OF PERFORATION. TWO DAYS OF HOSPITALIZATION WAS REQUIRED AS A RESULT OF THE ADVERSE EVENT. PATIENT¿S OUTCOME IS FULLY RECOVERED. THE PHYSICIAN OPINION ON CAUSALITY OF THE EVENT IS THAT THIS WAS PROCEDURE RELATED. NO ERROR MESSAGES ON BIOSENSE WEBSTER, INC. EQUIPMENT WAS REPORTED. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A ST. JUDE/ABBOTT MEDICAL 8.5 FRENCH AGILIS SHEATH, ST. JUDE/ABBOTT MEDICAL SL1 SHEATH, AND A ST. JUDE/ABBOTT MEDICAL BRK1 TRANSSEPTAL NEEDLE. NO ABLATION CATHETER WAS USED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1073615 SOUNDSTAR® ECO DIAGNOSTIC ULTRASOUND CATHETER CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BIOSENSE WEBSTER INC 10438577 E5075352 10846835008838

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| L| R ST. JUDE/ABBOTT MEDICAL 8.5 FRENCH AGILIS SHEATH| ST. JUDE/ABBOTT MEDICAL BRK1 TRANSSEPTAL NEEDLE| ST. JUDE/ABBOTT MEDICAL SL1 SHEATH