BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESCAPE¿

    MDR report key: 2536039 · Received April 16, 2012

    Report

    Report Number
    3005099803-2012-01332
    Event Type
    Malfunction
    Date Received
    April 16, 2012
    Date of Event
    March 17, 2012
    Report Date
    March 23, 2012
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED, BUT AN EVALUATION HAS NOT YET BEEN PERFORMED. THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE AND WE HAVE NOT YET DETERMINED THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. IF THERE IS ANY FURTHER RELEVANT INFORMATION, A SUPPLEMENTAL MANUFACTURER'S REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2012 REVEALED THAT THE REPORTED EVENT OCCURRED DURING THE PROCEDURE AND INSIDE THE PATIENT. IT WAS ALSO CONFIRMED THAT THERE WAS NO STONE IN THE BASKET WHEN IT FAILED TO OPEN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE. ANALYSIS OF THE RETURNED ESCAPE RETRIEVAL BASKET REVEALED THE BASKET WAS CLOSED AND THE OUTER SHEATH WAS BROKEN AT THE PROXIMAL END OF THE BLUE HEAT SHRINK. THE LUER WAS BROKEN AT THE BASE OF THE NIPPLE AND THE PORTION OF THE HANDLE CANNULA THAT WAS EXPOSED ON THE DISTAL END OF THE HANDLE WAS KINKED. SEVERAL KINKS WERE ALSO NOTED ALONG THE WORKING LENGTH OF THE OUTER SHEATH. THE BASKET AND ALL BASKET WIRES WERE PRESENT AND ATTACHED. THERE WAS A TORQUE MARK PRESENT ON THE HANDLE CAP TO INDICATE THE APPLICATION OF THE TORQUING PROCESS AND THE HANDLE CANNULA WAS VISIBLE THROUGH THE HANDLE. A FUNCTIONAL EVALUATION WAS NOT PERFORMED DUE TO THE DEFECTS ON THE SHEATH AND THE BROKEN LUER. REVIEW OF THE RETURNED DEVICE AND ALL AVAILABLE INFORMATION FAILED TO IDENTIFY A MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT, AND IS THEREFORE, UNDETERMINABLE. IT SHOULD BE NOTED THAT THE FAILURE OF THE BASKET TO OPEN BEFORE A STONE WAS RETRIEVED IS A NON REPORTABLE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ESCAPE RETRIEVAL BASKET WAS USED DURING A PROCEDURE ON (B)(6) 2012. THE PATIENT IDENTIFIER, AGE, DATE OF BIRTH, SEX AND WEIGHT ARE ALL UNKNOWN. ACCORDING TO THE COMPLAINANT, THE BASKET DID NOT OPEN OR CLOSE. IT IS UNKNOWN IF THE PROCEDURE TOOK PLACE INSIDE OR OUTSIDE THE PATIENT, OR HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ESCAPE RETRIEVAL BASKET WAS USED DURING A PROCEDURE ON (B)(6) 2012. THE PATIENT IDENTIFIER, AGE, DATE OF BIRTH, SEX AND WEIGHT ARE ALL UNKNOWN. ACCORDING TO THE COMPLAINANT, THE BASKET DID NOT OPEN OR CLOSE. IT IS UNKNOWN IF THE PROCEDURE TOOK PLACE INSIDE OR OUTSIDE THE PATIENT, OR HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1