BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENESYS HTA PROCERVA®

    MDR report key: 3822436 · Received May 20, 2014

    Report

    Report Number
    3005099803-2014-01852
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 17, 2014
    Report Date
    April 21, 2014
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THERE WAS A HOLE PRESENT ON THE SHEATH PROBE APPROXIMATELY 6.8CM FROM THE DISTAL TIP. RESIDUE WAS ALSO FOUND IN THE SHEATH ASSEMBLY. AS A HOLE WAS OBSERVED IN THE SHEATH DURING ANALYSIS OF THE RETURNED DEVICE, THE COMPLAINT INCIDENT WAS CONFIRMED. SINCE THE EVENT DESCRIPTION STATED THAT THE SHEATH WAS PUNCTURED BY THE TENACULUM DURING THE PROCEDURE, THE MOST PROBABLE ROOT CAUSE FOR THE COMPLAINT IS CAUSED BY OTHER DEVICE.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BUT AN EVALUATION HAS NOT YET BEEN PERFORMED; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED. AT THIS TIME, WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE FOR THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GENESYS HYDROTHERMABLATION PROCERVA PROCEDURE SET WAS USED IN A HYDROTHERMABLATION (HTA) PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE NON-HEATED PHASE OF THE PROCEDURE, THE SHEATH WAS PUNCTURED BY THE TENACULUM. ROOM TEMPERATURE SALINE WAS OBSERVED LEAKING FROM THE HOLE IN THE SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATION WAS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GENESYS HYDROTHERMABLATION PROCERVA PROCEDURE SET WAS USED IN A HYDROTHERMABLATION (HTA) PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE NON-HEATED PHASE OF THE PROCEDURE, THE SHEATH WAS PUNCTURED BY THE TENACULUM. ROOM TEMPERATURE SALINE WAS OBSERVED LEAKING FROM THE HOLE IN THE SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATION WAS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300300 GENESYS HTA PROCERVA® DEVICE, THERMAL ABLATION, ENDOMETRIAL MNB BOSTON SCIENTIFIC - SPENCER M006580210 16541792

    Patients

    Seq Age Sex Outcome Treatment
    1