BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZERO TIP NITINOL STONE RETRIEVAL BASKET

    MDR report key: 1821475 · Received August 31, 2010

    Report

    Report Number
    3005099803-2010-03681
    Event Type
    Malfunction
    Date Received
    August 31, 2010
    Date of Event
    July 2, 2010
    Report Date
    August 10, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. AT THIS TIME WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE FOR THIS EVENT. USER SUBMITTED MEDWATCH# (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ZERO-TIP BASKET WAS USED DURING A RIGHT PERCUTANEOUS ULTRASONIC LITHOTRIPSY ON A FEMALE PATIENT (PATIENT IDENTIFIER AND WEIGHT NOT GIVEN). ACCORDING TO THE USER SUBMITTED MEDWATCH ((B)(4)), THE PHYSICIAN PLACED THE KIDNEY STONE BASKET THROUGH THE SCOPE TO RETRIEVE A STONE. AT THE TIME HE WAS ATTEMPTING TO WITHDRAW THE BASKET, IT BECAME "STUCK." HE WAS ABLE TO FINALLY PULL BACK ON THE GUIDE WIRE TO REMOVE THE BASKET THAT WAS ATTACHED TO THE END. WHEN HE PULLED THE WIRE OUT FROM THE TOP OF THE SCOPE, THE BASKET WAS MISSING AND IT APPEARED TO HAVE PULLED OFF THE END OF THE GUIDE WIRE. THE BASKET BROKE FROM THE END OF THE GUIDE WIRE INTRAOPERATIVELY. HE USED ANOTHER BASKET TO REMOVE THE STONE. THEN WHEN HE WITHDREW, HE WITHDREW THE OPERATING SCOPE IN FULL AND NOTICED THAT THIS BASKET WAS ALSO LOOSE AT THE CONNECTION TO THE GUIDE WIRE. THIS WAS DONE EXTERNALLY TO THE PATIENT. THE FIRST BASKET COULD NOT BE LOCATED UNDER FLUORO EXAMINATION ALTHOUGH THE PHYSICIAN PERFORMED A THOROUGH EXAMINATION OF THE AREA. THE PHYSICIAN DOES NOT FEEL THAT IT WAS RETAINED, GIVEN HE COULD NOT VISUALIZE IT WITHIN THE SURGICAL ENVIRONMENT. PLEASE NOTE: THIS REPORT PERTAINS TO THE SECOND OF TWO DEVICES. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZERO TIP NITINOL STONE RETRIEVAL BASKET DISLODGER, STONE, BASKET, URETERAL, METAL FFL BOSTON SCIENTIFIC - SPENCER M0063901050 13315977

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR