BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEGURA HEMISPHERE STONE RETRIEVAL BASKET

    MDR report key: 1953080 · Received January 7, 2011

    Report

    Report Number
    3005099803-2011-00031
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    August 25, 2010
    Report Date
    December 17, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FFL
    PMA / PMN Number
    K935723
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. BASED ON THE INVESTIGATION, IT HAS BEEN DETERMINED THAT THE OUTER SHEATH OF THE DEVICE WAS KINKED, SCRAPED ON THE DISTAL END, TORN, AND A FRAGMENT OF THE DISTAL END WAS DETACHED. THE DEFECTS IDENTIFIED ON THE OUTER SHEATH INDICATE THE DEVICE WAS EXPOSED TO SIGNIFICANT FORCES. THE SCRAPING ON THE DISTAL END OF THE OUTER SHEATH WERE CONSISTENT WITH DAMAGE CAUSED WHEN RUBBED AGAINST A SHARPER OBJECT. THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS OPERATIONAL CONTEXT.

    Additional Manufacturer Narrative · 1

    THE UF/IMPORTER REPORT NUMBER IS (B)(4). 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 ON (B)(6) 2010 THAT A SEGURA HEMISPHERE STONE RETRIEVAL BASKET WAS USED IN A CYSTO RIGHT RETROGRADE PYLOGRAM OF THE RIGHT URETER PROCEDURE PERFORMED ON (B)(6) 2010 (PATIENT ID AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, NO IRREGULARITIES WERE NOTICED DURING THE PROCEDURE, AND THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. AFTER THE LAST PASS, THE PHYSICIAN NOTICED THE END OF THE SHEATH APPEARED "RAGGED," AND OPENED A SECOND SEGURA BASKET TO COMPARE TO THE DEVICE USED IN THE PROCEDURE. IT WAS THEN NOTICED THAT A PORTION OF THE SHEATH APPEARED TO BE MISSING. IT WAS DETERMINED THAT APPROXIMATELY 2 CM OF THE SHEATH WAS UNACCOUNTED FOR. THE DETACHED PORTION WAS NOT VISUALIZED UNDER FLUOROSCOPY; THE PIECE IS RADIOTRANSLUCENT. THE PROCEDURE WAS COMPLETED. ON (B)(6) 2010 THE PATIENT UNDERWENT A PREVIOUSLY SCHEDULED URETERAL STRICTURE AND STONE REMOVAL PROCEDURE, AND THE DETACHED PORTION OF THE SHEATH WAS FOUND AND REMOVED FROM THE PATIENT AT THIS TIME. THERE WERE NO PATIENT COMPLICATIONS IN EITHER PROCEDURE, AND THE PATIENT IS REPORTED TO BE DOING "FINE." NO LASER OR LITHOTRITE WAS USED IN THE PROCEDURE, AND THE STONE SIZE IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2010 THAT A SEGURA HEMISPHERE STONE RETRIEVAL BASKET WAS USED IN A CYSTO RIGHT RETROGRADE PYLOGRAM OF THE RIGHT URETER PROCEDURE PERFORMED ON (B)(6) 2010 (PATIENT ID AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, NO IRREGULARITIES WERE NOTICED DURING THE PROCEDURE, AND THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. AFTER THE LAST PASS, THE PHYSICIAN NOTICED THE END OF THE SHEATH APPEARED "RAGGED," AND OPENED A SECOND SEGURA BASKET TO COMPARE TO THE DEVICE USED IN THE PROCEDURE. IT WAS THEN NOTICED THAT A PORTION OF THE SHEATH APPEARED TO BE MISSING. IT WAS DETERMINED THAT APPROXIMATELY 2 CM OF THE SHEATH WAS UNACCOUNTED FOR. THE DETACHED PORTION WAS NOT VISUALIZED UNDER FLUOROSCOPY; THE PIECE IS RADIOTRANSLUCENT. THE PROCEDURE WAS COMPLETED. ON (B)(6) 2010 THE PATIENT UNDERWENT A PREVIOUSLY SCHEDULED URETERAL STRICTURE AND STONE REMOVAL PROCEDURE, AND THE DETACHED PORTION OF THE SHEATH WAS FOUND AND REMOVED FROM THE PATIENT AT THIS TIME. THERE WERE NO PATIENT COMPLICATIONS IN EITHER PROCEDURE, AND THE PATIENT IS REPORTED TO BE DOING "FINE." NO LASER OR LITHOTRITE WAS USED IN THE PROCEDURE, AND THE STONE SIZE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEGURA HEMISPHERE STONE RETRIEVAL BASKET DISLODGER, STONE, BASKET, URETERAL, METAL FFL BOSTON SCIENTIFIC - SPENCER M0063801060 13055146

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention