BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARACHUTE STONE RETRIEVAL BASKET

    MDR report key: 2130646 · Received June 16, 2011

    Report

    Report Number
    3005099803-2011-01920
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 20, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED PARACUTE STONE RETRIEVAL BASKET REVEALED THE DEVICE BASKET WOULD NOT OPEN. THE HANDLE SLIDE WAS ACTUATED WITH THE OUTER SHEATH HELD STRAIGHT, AND THE BASKET WOULD OPEN AND CLOSE. THE HANDLE SLIDE WAS ACTUATED WITH THE OUTER SHEATH HELD IN A LOOP, AND THE BASKET WOULD OPEN AND CLOSE WITH ASSISTANCE. THE BASKET AND ALL BASKET WIRES WERE PRESENT AND ATTACHED. THE WIRE SUB ASSEMBLY WAS SLIGHTLY BENT IN SEVERAL LOCATIONS ALONG THE WORKING LENGTH. PER THE EVENT INFORMATION, THE DEFECT WAS IDENTIFIED INSIDE THE PATIENT DURING THE PROCEDURE. MOST LIKELY, DUE TO SOME ASPECT OF THE PROCEDURE, THE WIRE SUB ASSEMBLY BECAME BENT. THIS WOULD CAUSE FRICTION BETWEEN THE OUTER SHEATH AND WIRE SUB ASSEMBLY WHEN ACTUATING THE HANDLE, WHICH MOST LIKELY WOULD NOT ALLOW THE BASKET TO OPEN/CLOSE PROPERLY. THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS OPERATIONAL/PHYSIOLOGICAL CONTEXT. DURING MANUFACTURING, THE DEVICES ARE 100% INSPECTED FOR DEVICE FUNCTIONALITY/INTEGRITY.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PARACHUTE STONE RETRIEVAL BASKET WAS USED IN A PROCEDURE ON A FEMALE PATIENT (PATIENT IDENTIFIER, SEX, AND WEIGHT UNKNOWN). ACCORDING TO THE COMPLAINANT, BASKET WAS PASSED THROUGH SEMI-RIGID SCOPE AND WOULD NOT OPEN. IT IS UNKNOWN IF STONES WERE PRESENT IN THE BASKET WHEN THE EVENT OCCURRED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PARACHUTE STONE RETRIEVAL BASKET WAS USED IN A PROCEDURE ON A FEMALE PATIENT (PATIENT IDENTIFIER, SEX, AND WEIGHT UNKNOWN). ACCORDING TO THE COMPLAINANT, BASKET WAS PASSED THROUGH SEMI-RIGID SCOPE AND WOULD NOT OPEN. IT IS UNKNOWN IF STONES WERE PRESENT IN THE BASKET WHEN THE EVENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARACHUTE STONE RETRIEVAL BASKET DISLODGER, STONE, BASKET, URETERAL, METAL FFL BOSTON SCIENTIFIC - SPENCER M0063203020

    Patients

    Seq Age Sex Outcome Treatment
    1