BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEGURA HEMISPHERE STONE RETRIEVAL BASKET

    MDR report key: 1993483 · Received February 16, 2011

    Report

    Report Number
    3005099803-2011-00410
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    January 20, 2011
    Report Date
    January 26, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FFL
    PMA / PMN Number
    K935729
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE INDICATED THAT THE FILAFORM TIP OF THE SEGURA RETRIEVAL BASKET WAS SLIGHTLY DISCOLORED. THE PRODUCT WAS DETERMINED TO HAVE MET BIOCOMPATIBILITY REQUIREMENTS AND THE APPARENT DISCOLORATION IS COSMETICALLY ACCEPTABLE PER BSC PROCEDURES. THIS DISCOLORATION DOES NOT POSE A RISK TO PATIENTS, THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THE COMPLAINT IS USER PREFERENCE. UPON FURTHER REVIEW OF ALL AVAILABLE INFORMATION THIS EVENT IS CONSIDERED A NON REPORTABLE EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RETURNED; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. AT THIS TIME, WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE OF THIS EVENT. IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    ON (B)(6), 2011, IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ON (B)(6), 2011, A SEGURA HEMISPHERE STONE RETRIEVAL BASKET WAS VISUALLY INSPECTED IN A DISTRIBUTOR WAREHOUSE. ACCORDING TO THE COMPLAINANT, OBSERVATION BY A DISTRIBUTION WAREHOUSE EMPLOYEE REVEALED THAT THE PROXIMAL END OF THE DEVICE STEM EXHIBITED A RUST LIKE STAIN. NO VISIBLE DAMAGE WAS NOTED ON THE PACKAGING AND THE PACKAGE SEAL WAS INTACT. REPORTEDLY, THE DEVICE WAS RECEIVED (B)(6), 2010, REMOVED FROM THE OUTER BOX AND STORED ON A SHELF IN AN AIR CONDITIONED, TEMPERATURE AND HUMIDITY CONTROLLED ROOM. THERE IS NO PATIENT OR PROCEDURE INFORMATION AVAILABLE AS THIS DEVICE WAS NEVER SHIPPED TO A CUSTOMER.

    Description of Event or Problem · 1

    ON (B)(6), 2011, IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ON (B)(6), 2011, A SEGURA HEMISPHERE STONE RETRIEVAL BASKET WAS VISUALLY INSPECTED IN A DISTRIBUTOR WAREHOUSE. ACCORDING TO THE COMPLAINANT, OBSERVATION BY A DISTRIBUTION WAREHOUSE EMPLOYEE REVEALED THAT THE PROXIMAL END OF THE DEVICE STEM EXHIBITED A RUST LIKE STAIN. NO VISIBLE DAMAGE WAS NOTED ON THE PACKAGING AND THE PACKAGE SEAL WAS INTACT. REPORTEDLY, THE DEVICE WAS RECEIVED (B)(6), 2010, REMOVED FROM THE OUTER BOX AND STORED ON A SHELF IN AN AIR CONDITIONED, TEMPERATURE AND HUMIDITY CONTROLLED ROOM. THERE IS NO PATIENT OR PROCEDURE INFORMATION AVAILABLE AS THIS DEVICE WAS NEVER SHIPPED TO A CUSTOMER.

    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 M0063801190 13085877

    Patients

    Seq Age Sex Outcome Treatment
    1