BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSATION¿ SHORT THROW

    MDR report key: 4913311 · Received July 14, 2015

    Report

    Report Number
    3005099803-2015-01999
    Event Type
    Malfunction
    Date Received
    July 14, 2015
    Date of Event
    June 24, 2015
    Report Date
    June 25, 2015
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    FDI
    PMA / PMN Number
    K941750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EVALUATION OF THE RETURNED DEVICE FOUND A HAIR INSIDE THE SEALED PACKAGE. THE INVESTIGATION CONFIRMED THE PRESENCE OF A FOREIGN MATERIAL INSIDE THE POUCH; THE MOST PROBABLE ROOT CASE FOR THIS EVENT IS MANUFACTURING. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND NO DEVIATIONS WERE FOUND. A SEARCH OF THE COMPLAINT DATABASE CONFIRMED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED BATCH.

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION MEDIUM OVAL SNARE WAS PREPARED FOR USE IN THE COLON DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, A HAIR WAS FOUND INSIDE THE STERILE PACKAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SENSATION SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION MEDIUM OVAL SNARE WAS PREPARED FOR USE IN THE COLON DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, A HAIR WAS FOUND INSIDE THE STERILE PACKAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SENSATION SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SENSATION MEDIUM OVAL SNARE WAS PREPARED FOR USE IN THE COLON DURING A POLYPECTOMY PROCEDURE PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, A HAIR WAS FOUND INSIDE THE STERILE PACKAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SENSATION SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457029 SENSATION¿ SHORT THROW SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00560311 17573450

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR