BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARACHUTE STONE RETRIEVAL BASKET

    MDR report key: 1833127 · Received September 14, 2010

    Report

    Report Number
    3005099803-2010-03759
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Date of Event
    June 10, 2010
    Report Date
    August 23, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BUT AN EVALUATION HAS NOT YET BEEN PERFORMED; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED. AT THIS TIME, WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE FOR THE EVENT.

    Additional Manufacturer Narrative · 1

    THE CONDITION OF THE RETURNED DEVICE WAS CONSISTENT WITH THE COMPLAINT INCIDENT THAT THE BASKET WAS UNABLE TO OPEN AND CLOSE. BASED ON THE ANALYSIS, KINKS WERE PRESENT IN THE HANDLE CANNULA AND WIRE SHEATH ASSEMBLY. ADDTIONALLY, A BEND WAS PRESENT ON THE OUTER SHEATH, WHICH WAS MOST LIKELY A RESULT OF FORCES RECEIVED DURING THE PROCEDURE. THE DAMAGE TO THE DEVICE COULD HAVE OCCURRED DURING INSERTION INTO THE SCOPE, POSITIONING THE DEVICE INSIDE THE PATRIENT, OR WHEN TRYING TO EXTRACT THE STONE. THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2010 THAT A PARACHUTE STONE RETRIEVAL BASKET WAS USED IN A CYSTOSCOPY PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, THE BASKET WOULD NOT OPEN AND CLOSE. IT IS UNKNOWN IF THE PROBLEM OCCURRED INSIDE THE PATIENT, OR IF A STONE WAS IN THE DEVICE WHEN THE MALFUNCTION OCCURRED. A SECOND PARACHUTE STONE RETRIEVAL BASKET WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE IS REPORTED TO BE UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2010 THAT A PARACHUTE STONE RETRIEVAL BASKET WAS USED IN A CYSTOSCOPY PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, THE BASKET WOULD NOT OPEN AND CLOSE. IT IS UNKNOWN IF THE PROBLEM OCCURRED INSIDE THE PATIENT, OR IF A STONE WAS IN THE DEVICE WHEN THE MALFUNCTION OCCURRED. A SECOND PARACHUTE STONE RETRIEVAL BASKET WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE IS REPORTED TO BE UNKNOWN.

    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 8908714

    Patients

    Seq Age Sex Outcome Treatment
    1