BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZERO TIP

    MDR report key: 16404117 · Received February 20, 2023

    Report

    Report Number
    3005099803-2023-00850
    Event Type
    Injury
    Date Received
    February 20, 2023
    Date of Event
    February 1, 2023
    Report Date
    April 17, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FFL
    UDI-DI
    08714729469643
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF DEVICE CODE A0401 CAPTURES THE REPORTABLE EVENT OF BASKET WIRE BREAK. BLOCK H10: THE RETURNED ZERO TIP BASKET WAS ANALYZED, AND A VISUAL INSPECTION REVEALED THAT THE SHEATH AT THE DISTAL END WAS KINKED. THE HANDLE IS IN GOOD CONDITION. AN X-RAY TEST REVEALED THAT THE BASKET WAS MISSING. A MICROSCOPE EXAMINATION REVEALED GLUE RESIDUES ON THE CANNULA'S NOTCH. THE REPORTED EVENT OF BASKET WIRE BREAK WAS NOT CONFIRMED. WITH ALL OF THE INFORMATION GATHERED AND AFTER THE PRODUCT ANALYSIS, EVIDENCE OF THE BASKET DETACHED (MISSING) AND SHEATH BENT/KINKED WAS POSSIBLE. FURTHERMORE, AFTER DISASSEMBLING THE DEVICE, IT WAS POSSIBLE TO NOTICE THAT THE NOTCHED CANNULA HAS CRIMPS AND WIRE GLUE MARKS INDICATING THAT THE BASKET WAS PRESENT. IT IS POSSIBLE THAT THE FAILURE WAS CAUSED BY AN INTERACTION OF THE DEVICE WITH ANOTHER DEVICE, SUCH AS AN EXCESS OF FORCE APPLIED OVER THE DEVICE DURING THE PROCEDURE. THE SHEATH BENT/KINK ISSUE IS RELATED TO THE BASKET DETACHMENT; ONCE THE BASKET WAS REMOVED, SOME MANIPULATION, SUCH AS HANDLING THE DEVICE WITH EXCESSIVE FORCE, COULD HAVE CAUSED THE BENT/KINK. BECAUSE THE INVESTIGATION FINDINGS DO NOT LEAD TO A CLEAR CONCLUSION ABOUT THE CAUSE OF THE REPORTED ADVERSE EVENT, CAUSE NOT ESTABLISHED IS SELECTED AS THE MOST PROBABLE CAUSE FOR THE COMPLAINT.

    Additional Manufacturer Narrative · 0

    DEVICE CODE A0401 CAPTURES THE REPORTABLE EVENT OF BASKET WIRE BREAK.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ZERO TIP BASKET WAS USED IN THE URETER DURING A URETEROSCOPY WITH LASER LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE BASKET WIRE DETACHED INSIDE THE PATIENT. THE DETACHED WIRE WAS RETRIEVED USING A GRASPING FORCEPS. THE PROCEDURE WAS COMPLETED WITH ANOTHER ZERO TIP BASKET. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ZERO TIP BASKET WAS USED IN THE URETER DURING A URETEROSCOPY WITH LASER LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE BASKET WIRE DETACHED INSIDE THE PATIENT. THE DETACHED WIRE WAS RETRIEVED USING A GRASPING FORCEPS. THE PROCEDURE WAS COMPLETED WITH ANOTHER ZERO TIP BASKET. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1573064 ZERO TIP DISLODGER, STONE, BASKET, URETERAL, METAL FFL BOSTON SCIENTIFIC CORPORATION M0063901050 0030696882 08714729469643

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention