BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL

    MDR report key: 2515381 · Received April 3, 2012

    Report

    Report Number
    3005099803-2012-01093
    Event Type
    Malfunction
    Date Received
    April 3, 2012
    Date of Event
    December 14, 2011
    Report Date
    December 14, 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

    (B)(6). NOTE: THIS EVENT, AS REPORTED, DID NOT REFLECT AN MDR REPORTABLE SCENARIO; HOWEVER, EVALUATION OF THE RETURNED DEVICE REVEALED AN MDR-REPORTABLE MALFUNCTION. THIS MANUFACTURER REPORT IS BEING SUBMITTED BASED ON THE EVALUATION RESULTS. ANALYSIS OF THE RETURNED STONE CONE RETRIEVAL COIL REVEALED A KINK IN THE BLUE SHEATH. FURTHER VISUAL INSPECTION NOTED THAT THE BLUE/GREEN HEAT SHRINK WAS MISSING FROM DISTAL STOP TO THE DISTAL BALL. FUNCTIONAL EVALUATION WAS PERFORMED AND THE BASKET WOULD NOT FULLY CLOSE. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND CONFIRMED THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH THE DEVICE MASTER RECORD. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A STONE CONE RETRIEVAL COIL WAS USED IN A PROCEDURE ON (B)(6) 2011. THE PATIENT WAS MALE (IDENTIFIER, AGE, DATE OF BIRTH AND WEIGHT UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE WHILE INSIDE THE PATIENT, THE DEVICE WAS UNABLE TO OPEN AND SEVER RESISTANCE WAS MET. AFTER REMOVING THE DEVICE FROM THE PATIENT, THE DEVICE WAS TESTED AND IT WAS ABLE TO OPEN AND CLOSE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT'S CONDITION POST PROCEDURE WAS GOOD.

    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 0000895450

    Patients

    Seq Age Sex Outcome Treatment
    1