BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARACHUTE STONE RETRIEVAL DEVICE

    MDR report key: 1476695 · Received June 22, 2009

    Report

    Report Number
    3005099803-2009-02994
    Event Type
    Malfunction
    Date Received
    June 22, 2009
    Date of Event
    March 11, 2009
    Report Date
    March 13, 2009
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PARACHUTE BASKET WAS RECEIVED FOR EVALUATION. RESIDUE WAS OBSERVED ON THE BASKET TIP INDICATING USE. A VISUAL INSPECTION FOUND THE SHEATH OF THE DEVICE SEPARATED IN THE MIDDLE. A FUNCTIONAL CHECK FOUND THE BASKET OF THE DEVICE CLOSED AND COULD NOT BE OPENED DUE TO THE SHEATH DAMAGE. THE EVALUATION REVEALED THAT THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE DEVICE WOULD NOT WORK. THE INVESTIGATION FOUND THE BASKET WAS CLOSED AND COULD NOT BE OPENED DUE TO THE SHEATH BEING SEPARATED. THE SEPARATED ENDS OF THE SHEATH WERE TORN AND NOT CRUSHED OR BUCKLED. BASED ON THE INVESTIGATION OF THE DEVICE, IT APPEARS THE SHEATH OF THE DEVICE WAS TORN BY AN UNK EXTERNAL OBJECT. THERE WAS NO INDICATION OF ANY DEFECT WITH THE SHEATH THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE SEPARATION. THE PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS THAT THE DAMAGE WAS CAUSED BY ANOTHER DEVICE. (B) (4).

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED THAT THE CLINICIAN WAS PERFORMING A FLEXIBLE URETEROSCOPY ON A PT. ACCORDING TO THE COMPLAINANT, THE CLINICIAN HAD USED A HOLMIUM LASER TO BREAK UP A STONE IN THE PT URETER. HE THEN PREPARED TO USE A PARACHUTE BASKET TO REMOVE STONE FRAGMENTS. THE BASKET WAS OBTAINED AND THEN TESTED TO ENSURE THAT IT FUNCTIONED CORRECTLY BEFORE USING, BUT THE BASKET WOULD NOT OPEN OR CLOSE. THE CLINICIAN THEN OPENED A 2ND BASKET, BUT THAT BASKET ALSO WOULD NOT OPEN OR CLOSE (SEE ATTACHED MEDWATCH REPORT # 3005099803-2009-02995 FOR A DESCRIPTION OF THE SECOND EVENT). THE CLINICIAN THEN OBTAINED ANOTHER DEVICE AND SUCCESSFULLY REMOVED ALL THE STONE FRAGMENTS FROM THE PATIENT. THERE WERE NO PT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "STABLE". ON MAY 28, 2009, THE EVALUATION OF THE RETURNED DEVICE REVEALED THAT THE DEVICE SHEATH WAS TORN IN THE MIDDLE PORTION OF THE DEVICE, NOT NEAR THE HANDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARACHUTE STONE RETRIEVAL DEVICE FFL BOSTON SCIENTIFIC CORPORATION M0063203020 12092834

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK