BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESCAPE NITINOL STONE RETRIEVAL BASKET

    MDR report key: 1820775 · Received August 31, 2010

    Report

    Report Number
    3005099803-2010-03725
    Event Type
    Malfunction
    Date Received
    August 31, 2010
    Report Date
    August 12, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONDITION OF THE RETURNED PRODUCT INDICATED THE DEVICE WAS USED IN THE PROCEDURE. THEREFORE, IT FUNCTIONED WHEN REMOVED FROM THE PACKAGING. THERE WERE MANY BENDS ALONG THE WORKING LENGTH, AND THE OUTER SHEATH WAS TORN AT THE DISTAL END OF THE BLACK HEAT SHRINK. ADDITIONALLY, A BASKET WIRE WAS BROKEN, BUT NOT DETACHED FROM THE DEVICE. THE BROKEN WIRE SHOWED SIGNS OF BURNS, MOST LIKELY FROM A LITHOTRIPSY LASER. THE HANDLE CANNULA HAD BEEN INSTALLED, BUT MOST LIKELY PULLED OUT DURING THE PROCEDURE. THE DFU STATES: "IF RESISTANCE IS ENCOUNTERED DURING ADVANCEMENT OR WITHDRAWAL OF THE BASKET, DO NOT EXERT EXCESSIVE FORCE. KINKS IN THE SHEATH WILL HINDER THE MECHANICAL OPERATION OF THE BASKET." BASED ON THE CONDITION OF THE RETURNED DEVICE, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS OPERATIONAL CONTEXT. IT IS ALSO NOTED THAT THE SHEATH TEARING FROM THE HANDLE HUB, AND/OR A BROKEN, BUT NOT DETACHED BASKET WIRE ARE NOT MEDWATCH REPORTABLE EVENTS.

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS NOT KNOWN PER THE COMPLAINANT; THEREFORE, THE DEVICE MANUFACTURE AND EXPIRATION DATES CANNOT BE DETERMINED. 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

    THE DATE OF EVENT IS UNKNOWN. AN ESCAPE NITINOL STONE RETRIEVAL BASKET WAS RECEIVED BY BOSTON SCIENTIFIC CORPORATION ON AUGUST 12, 2010. ACCORDING TO THE COMPLAINANT, "THE TIP OF THE DEVICE GOT STUCK SOON" WHILE PERFORMING A "STONE REMOVAL" PROCEDURE. ADDITIONAL EVENT DETAILS ARE REPORTED TO BE UNAVAILABLE. 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 "GOOD."

    Description of Event or Problem · 1

    NOTE: THE DATE OF EVENT IS UNKNOWN. AN ESCAPE NITINOL STONE RETRIEVAL BASKET WAS RECEIVED BY BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, "THE TIP OF THE DEVICE GOT STUCK SOON" WHILE PERFORMING A "STONE REMOVAL" PROCEDURE. ADDITIONAL EVENT DETAILS ARE REPORTED TO BE UNAVAILABLE. 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 "GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESCAPE NITINOL STONE RETRIEVAL BASKET DISLODGER, STONE, BASKET, URETERAL, METAL FFL BOSTON SCIENTIFIC - SPENCER M0063902010

    Patients

    Seq Age Sex Outcome Treatment
    1