BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZERO TIP NITINOL STONE RETRIEVAL BASKET

    MDR report key: 1781746 · Received August 3, 2010

    Report

    Report Number
    3005099803-2010-03275
    Event Type
    Malfunction
    Date Received
    August 3, 2010
    Date of Event
    June 25, 2010
    Report Date
    July 14, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED ZERO TIP NITINOL RETRIEVAL BASKET REVEALED THE BASKET WAS RETURNED OPEN AND WAS ABLE TO RETRACT IN AND OUT THE SHEATH WITH EASE WHEN THE HANDLE WAS ACTUATED. THERE WERE KINKS FELT THROUGHOUT THE LENGTH OF THE SHEATH, HOWEVER, THIS DID NOT PREVENT THE BASKET FROM BEING ABLE TO RETRACT AND DEPLOY AS THE HANDLE WAS OPERATED. THE SHEATH WAS ALSO FOUND TO BE .45CM OUT OF SPEC. THERE WAS NO MALFUNCTION FOUND DURING PRODUCT ANALYSIS. THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR EVENT OF "WOULD NOT CLOSE" IS DETERMINED TO BE NOT CONFIRMED. HOWEVER, SINCE THE DEVICE WAS ALSO FOUND TO HAVE KINKS AND WAS OUT OF SPECIFICATION, A SECONDARY ROOT CAUSE IS DETERMINED TO BE OPERATIONAL CONTEXT.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED, BUT AN EVALUATION HAS NOT YET BEEN PERFORMED. THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE AND WE HAVE NOT YET DETERMINED THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. IF THERE IS ANY FURTHER RELEVANT INFORMATION, A SUPPLEMENTAL MANUFACTURER'S REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ZERO-TIP NITINOL BASKET WAS BEING USED IN AN URETEROSCOPY PROCEDURE ON (B)(6) 2010 (PATIENT WEIGHT UNKNOWN). ACCORDING TO THE COMPLAINANT, THE JAWS OF THE ZERO TIP NITINOL RETRIEVAL BASKET WOULD NOT CLOSE DURING THE CASE. THE DEVICE WAS REMOVED FROM THE PATIENT WITHOUT INCIDENT, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A SECOND ZERO-TIP NITINOL BASKET. THERE WERE NO COMPLICATIONS AND THE PATIENT WAS REPORTED TO BE STABLE AT THE CONCLUSION OF THE PROCEDURE. FOLLOW UP INFORMATION RECEIVED FROM THE FACILITY STATED THERE WAS A STONE IN THE BASKET WHEN IT WOULD NOT CLOSE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ZERO-TIP NITINOL BASKET WAS BEING USED IN AN URETEROSCOPY PROCEDURE ON (B)(6), 2010 (PATIENT WEIGHT UNKNOWN). ACCORDING TO THE COMPLAINANT, THE JAWS OF THE ZERO TIP NITINOL RETRIEVAL BASKET WOULD NOT CLOSE DURING THE CASE. THE DEVICE WAS REMOVED FROM THE PATIENT WITHOUT INCIDENT, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A SECOND ZERO-TIP NITINOL BASKET. THERE WERE NO COMPLICATIONS AND THE PATIENT WAS REPORTED TO BE STABLE AT THE CONCLUSION OF THE PROCEDURE. SEVERAL ATTEMPTS MADE TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL.

    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 12982585

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR