BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESCAPE¿

    MDR report key: 2534661 · Received April 13, 2012

    Report

    Report Number
    3005099803-2012-01160
    Event Type
    Injury
    Date Received
    April 13, 2012
    Date of Event
    March 19, 2012
    Report Date
    March 20, 2012
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED ESCAPE RETRIEVAL BASKET REVEALED THAT THE BASKET WAS OPEN WITH THE OUTER SHEATH TORN/DETACHED NEAR THE DISTAL END. THE DETACHED FRAGMENT WAS APPROXIMATELY 10.4CM LONG AND WAS KINKED IN SEVERAL LOCATIONS. SEVERAL KINKS WERE ALSO NOTED ON THE SECTION OF THE OUTER SHEATH THAT REMAINED ATTACHED TO THE DISTAL HANDLE. THE BASKET WIRE SUB-ASSEMBLY WAS BENT APPROXIMATELY 3CM PROXIMAL TO THE BASKET. THE BASKET WAS BENT/KINKED AND ONE OF THE BASKET WIRES WAS BROKEN AT ITS DISTAL END. THERE WAS A TORQUE MARK PRESENT ON THE HANDLE CAP TO INDICATE THE APPLICATION OF THE TORQUING PROCESS. THE HANDLE CANNULA WAS VISIBLE THROUGH THE HANDLE. A FUNCTIONAL EVALUATION WAS PERFORMED AND THE HANDLE ACTUATED SMOOTHLY. THE BASKET HOWEVER, WOULD NOT CLOSE DUE TO THE DETACHED SHEATH SECTION. DURING MANUFACTURING, THE DEVICES ARE 100% INSPECTED FOR DEVICE FUNCTIONALITY/INTEGRITY. THE DEFECTS IDENTIFIED ON THE DEVICE WERE MOST LIKELY DUE TO SOME OPERATIONAL OR ANATOMICAL ASPECT ENCOUNTERED DURING THE PROCEDURE; THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS OPERATIONAL/PHYSIOLOGICAL CONTEXT.

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVALUATION: RECEIVED, NOT YET EVALUATED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ESCAPE RETRIEVAL BASKET WAS USED DURING A KIDNEY STONE REMOVAL PROCEDURE ON (B)(6) 2012. THE PATIENT IDENTIFIER, AGE, DATE OF BIRTH, SEX AND WEIGHT ARE ALL UNKNOWN. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE OUTER COVERING OF THE SHEATH PEELED OFF INSIDE THE PATIENT. THERE WAS A LASER ADVANCED BESIDE THE BASKET, BUT WAS NOT ACTIVATED. THE SINGULAR PIECE OF COATING WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT WITH ANOTHER BASKET. THE PROCEDURE WAS THEN COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT'S CONDITION POST PROCEDURE WAS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ESCAPE RETRIEVAL BASKET WAS USED DURING A KIDNEY STONE REMOVAL PROCEDURE ON (B)(6) 2012. THE PATIENT IDENTIFIER, AGE, DATE OF BIRTH, SEX AND WEIGHT ARE ALL UNKNOWN. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE OUTER COVERING OF THE SHEATH PEELED OFF INSIDE THE PATIENT. THERE WAS A LASER ADVANCED BESIDE THE BASKET, BUT WAS NOT ACTIVATED. THE SINGULAR PIECE OF COATING WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT WITH ANOTHER BASKET. THE PROCEDURE WAS THEN COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT'S CONDITION POST PROCEDURE WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESCAPE¿ DISLODGER, STONE, BASKET, URETERAL, METAL FFL BOSTON SCIENTIFIC - SPENCER M0063902010 14916955

    Patients

    Seq Age Sex Outcome Treatment
    1