BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL

    MDR report key: 2070181 · Received April 27, 2011

    Report

    Report Number
    3005099803-2011-01310
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Report Date
    April 7, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FGO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON FURTHER REVIEW OF ALL AVAILABLE INFORMATION THIS EVENT IS CONSIDERED A NON REPORTABLE EVENT. (B)(4).

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT A PORTION OF THE HEAT-SHRINK WAS PULLED AWAY FROM THE DISTAL STOP. NO OTHER ANOMALIES WERE NOTED. FUNCTIONALLY THE DEVICE WAS ABLE TO BE OPENED AND CLOSED WITH NO DIFFICULTY. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS NOT CONSISTENT WITH THE COMPLAINT THAT THE DEVICE WAS DIFFICULT TO EXTEND/RETRACT. DEVICE EVALUATION FOUND THAT A PORTION OF THE HEAT-SHRINK WAS PULLED AWAY FROM THE DISTAL STOP. THE MOST PROBABLE ROOT CAUSE IS UNDETERMINABLE DUE TO THE LACK OF EVIDENCE IDENTIFYING THE USE OF THE DEVICE. (B)(4)

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL WAS TO BE USED DURING A REMOVAL OF URETERAL STONE PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING PREPARATION FOR THE PROCEDURE THE DEVICE WAS TESTED AND RESISTANCE WAS FELT WHILE EXTENDING AND RETRACTING THE CONE. THE PROCEDURE WAS COMPLETED WITH ANOTHER STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL DEVICE. 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. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; HEAT-SHRINK/SHEATH DAMAGE.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL WAS TO BE USED DURING A REMOVAL OF URETERAL STONE PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING PREPARATION FOR THE PROCEDURE THE DEVICE WAS TESTED AND RESISTANCE WAS FELT WHILE EXTENDING AND RETRACTING THE CONE. THE PROCEDURE WAS COMPLETED WITH ANOTHER STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL DEVICE. 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. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; HEAT-SHRINK/SHEATH DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL DISLODGER, STONE, FLEXIBLE FGO BOSTON SCIENTIFIC - MARLBOROUGH M0063903200

    Patients

    Seq Age Sex Outcome Treatment
    1