BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZERO TIP

    MDR report key: 20268147 · Received September 20, 2024

    Report

    Report Number
    2124215-2024-58617
    Event Type
    Malfunction
    Date Received
    September 20, 2024
    Date of Event
    August 28, 2024
    Report Date
    November 26, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FFL
    UDI-DI
    08714729469643
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK E1: INITIAL REPORTER FACILITY NAME: (B)(6) HOSPITAL. BLOCK H6: DEVICE CODE A0501 CAPTURES THE REPORTABLE EVENT OF BASKET DETACHED. BLOCK H11: INVESTIGATION RESULTS: THE RETURNED ZERO TIP BASKET WAS ANALYZED, AND A VISUAL EVALUATION NOTED THAT HANDLE RETURNED IN GOOD CONDITION. MEDIA ANALYSIS SHOWS THAT THE ZERO TIP BASKET HAS THE SHEATH BENT/KINKED. MICROSCOPIC EXAMINATION WAS PERFORMED UNDER MAGNIFICATION, AND IT WAS POSSIBLE TO SEE THAT THE SHEATH WAS BENT/KINKED AT THE DISTAL SECTION. ADDITIONALLY, IT WAS STRETCHED AND TORN AT THE DISTAL SECTION. FUNCTIONAL EXAMINATION WAS PERFORMED, AND THE HANDLE WAS ACTUATED, HOWEVER, IT WAS NOT POSSIBLE TO SEE THE BASKET. DESTRUCTIVE TEST WAS PERFORMED, AND BEFORE REMOVING THE CAP FROM THE DEVICE, THE EVIDENCE OF THE TORQUE MARK ON THE CAP WAS NOTED. ONCE THE CAP WAS REMOVED, IT WAS POSSIBLE TO SEE THAT THE HANDLE CANULA WAS PROPERLY ASSEMBLED TO THE PINCH VISE. THE PULL WIRE WAS REMOVED FROM THE DEVICE, IT WAS POSSIBLE TO SEE THAT IT WAS PROPERLY ASSEMBLED TO THE NOTCH CANULA. ALSO, IT WAS POSSIBLE TO SEE THE BASKET THAT WAS PROPERLY ASSEMBLED TO THE NOTCH CANNULA AS WELL. THERE WAS EVIDENCE OF THE 8 CRIMP MARKS AND NO ISSUES WERE FOUND ON THE BASKET. WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THAT THE REPORTED EVENT OF BASKET DETACHMENT WAS NOT CONFIRMED SINCE IT WAS POSSIBLE TO SEE THE BASKET INSIDE THE SHEATH, AND IT DID NOT HAVE ANY ISSUE. THE OBSERVED FINDINGS OF SHEATH BENT/KINKED, TORN AND STRETCHED COULD BE RELATED TO HANDLING AND MANIPULATION OF THE DEVICE DURING PROCEDURE, IT IS PROBABLE THAT AN EXCESS OF FORCE APPLIED TO THE DEVICE SUCH AS OPERATIONAL FACTORS DURING THE USE COULD HAVE CAUSED THESE DEVICE ISSUES. ALSO, SINCE THE SHEATH WAS STRETCHED, THIS COULD HAVE CAUSED THE BASKET TO GET STUCK INSIDE THE SHEATH AND THE BASKET WAS NOT VISIBLE TO THE CUSTOMER. BASED ON INFORMATION AVAILABLE AND INVESTIGATION RESULTS, AN INVESTIGATION CONCLUSION CODE OF ADVERSE EVENT RELATED TO PROCEDURE WAS ASSIGNED TO THIS INVESTIGATION BECAUSE THE ADVERSE EVENT OCCURRED DURING THE PROCEDURE AND THE DEVICE HAD NO INFLUENCE ON THE EVENT.

    Additional Manufacturer Narrative · 0

    BLOCK E1: INITIAL REPORTER FACILITY NAME: (B)(6) HOSPITAL. BLOCK H6: DEVICE CODE A0501 CAPTURES THE REPORTABLE EVENT OF BASKET DETACHED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A ZERO TIP BASKET DEVICE WAS USED DURING A URETEROLITHOTOMY PROCEDURE. DURING THE PROCEDURE, AFTER THE BASKET DEPLOY THE STONE OUTSIDE THE PATIENT'S BODY, THE ENTIRE BASKET FELL OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A ZERO TIP BASKET DEVICE WAS USED DURING A URETEROLITHOTOMY PROCEDURE. DURING THE PROCEDURE, AFTER THE BASKET DEPLOY THE STONE OUTSIDE THE PATIENT'S BODY, THE ENTIRE BASKET FELL OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1472121 ZERO TIP DISLODGER, STONE, BASKET, URETERAL, METAL FFL BOSTON SCIENTIFIC CORPORATION M0063901050 0033380604 08714729469643

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male