BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZERO TIP?

    MDR report key: 3123816 · Received May 22, 2013

    Report

    Report Number
    3005099803-2013-04122
    Event Type
    Injury
    Date Received
    May 22, 2013
    Date of Event
    April 9, 2013
    Report Date
    May 6, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FFL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL ASSESSMENT OF THE RETURNED ZERO TIP RETRIEVAL BASKET REVEALED THAT THE OUTER SHEATH WAS KINKED IN SEVERAL LOCATIONS, A KINK LOCATED APPROXIMATELY 3.1CM FROM THE DISTAL END OF THE SHEATH WAS COLLAPSED. THERE WAS A TORQUE MARK PRESENT ON THE HANDLE CAP TO INDICATE THE APPLICATION OF THE TORQUING PROCESS. THE HANDLE CANNULA WAS VISIBLE THROUGH THE HANDLE. FUNCTIONAL EVALUATION NOTED THAT WHEN THE HANDLE WAS ACTUATED, THE HANDLE WOULD MOVE SMOOTHLY BUT THE BASKET WOULD NOT OPEN. THE LUER AND SHEATH WERE REMOVED FROM THE HANDLE. THE SHEATH WAS REMOVED FROM THE WIRE SUB-ASSEMBLY. THE BASKET WAS DETACHED WHEN RECEIVED BUT THE DETACHED BASKET WAS NOT RETURNED. THE BASKET DETACHED AT THE SPLICE CANNULA. CRIMP MARKS WERE PRESENT ON THE SPLICE CANNULA TO INDICATE PROPER CRIMPING DURING MANUFACTURING. ADHESIVE RESIDUE WAS PRESENT IN THE SPLICE CANNULA INDICATE ADHESIVE APPLIED DURING MANUFACTURING. A DIMENSIONAL VERIFICATION WAS PERFORMED ON THE SHEATH SUB-ASSEMBLY AND MEASURED APPROXIMATELY 121.5CM, WHICH MEETS SPECIFICATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND CONFIRMED THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH THE DEVICE MASTER RECORD. DURING MANUFACTURING, THE DEVICES ARE 100% INSPECTED FOR DEVICE FUNCTIONALITY/INTEGRITY. THE DEFECTS IDENTIFIED ON THE DEVICE WERE MOST LIKELY DUE TO SOME OPERATIONAL OR ANATOMICAL ASPECT ENCOUNTERED DURING THE PROCEDURE; THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS OPERATIONAL/PHYSIOLOGICAL CONTEXT.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A 1.9 ZERO TIP NITINOL RETRIEVAL BASKET WAS USED DURING A FLEXIBLE URETERORENOSCOPY (URS) PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BASKET BROKE INTO TWO PIECES. THE 25 CM-DETACHED-FRAGMENT WAS REMOVED FROM THE PATIENT WITH THE USE OF A FORCEPS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A 1.9 ZERO TIP NITINOL RETRIEVAL BASKET WAS USED DURING A FLEXIBLE URETERORENOSCOPY (URS) PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BASKET BROKE INTO TWO PIECES. THE 25 CM-DETACHED-FRAGMENT WAS REMOVED FROM THE PATIENT WITH THE USE OF A FORCEPS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225920 ZERO TIP? DISLODGER, STONE, BASKET, URETERAL, METAL FFL BOSTON SCIENTIFIC - SPENCER M0063901050 15867774

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR