BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEPHROSTOMY SHEATHS AND DILATORS

    MDR report key: 21028294 · Received December 27, 2024

    Report

    Report Number
    2124215-2024-82171
    Event Type
    Injury
    Date Received
    December 27, 2024
    Date of Event
    January 1, 2022
    Report Date
    April 15, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    GCC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B5 DESCRIBE EVENT OR PROBLEM: EXACT DATES OF PROCEDURE UNKNOWN, APPROXIMATE DATE USED BASED ON THE RANGE PROVIDED. MEMIK, O., VOYVODA, B., USTUNER, M., KARSLI, O., HALAT, A. O., & OZCAN, L. (2023). WHAT IS THE SAFE AND EFFECTIVE DILATOR NUMBER DURING ACCESS IN PCNL? THREE-SHOT DILATION VERSUS CLASSICAL SEQUENTIAL AMPLATZ DILATION. BMC UROLOGY, 23(1). HTTPS://DOI.ORG/10.1186/S12894-023-01368-6. BLOCK D4, H4: DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BLOCK H11: CORRECTION TO FIELD BLOCK H6: PATIENT CODES.

    Additional Manufacturer Narrative · 0

    B5 DESCRIBE EVENT OR PROBLEM: EXACT DATES OF PROCEDURE UNKNOWN, APPROXIMATE DATE USED BASED ON THE RANGE PROVIDED. MEMIK, O., VOYVODA, B., USTUNER, M., KARSLI, O., HALAT, A. O., & OZCAN, L. (2023). WHAT IS THE SAFE AND EFFECTIVE DILATOR NUMBER DURING ACCESS IN PCNL? THREE-SHOT DILATION VERSUS CLASSICAL SEQUENTIAL AMPLATZ DILATION. BMC UROLOGY, 23(1). HTTPS://DOI.ORG/10.1186/S12894-023-01368-6.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN BMC UROLOGY THAT A STUDY WAS CONDUCTED TO COMPARE CONVENTIONAL SEQUENTIAL AMPLATZ DILATATION (SAD) USING TEN DILATORS AND A METHOD USING THREE DILATORS (3SD). THE STUDY INCLUDED DATA FROM 283 PATIENTS, BEING 138 IN THE 3SD GROUP AND 145 IN THE SAD GROUP; THE CASES OCCURRED BETWEEN 2012 AND 2022. IT WAS SAID THAT AN INTRODUCER PERCUTANEOUS NEEDLE AND AN AMPLATZ ACCESS SHEATH WERE INTRODUCED IN THE PRONE POSITION AS PART OF THE DILATATION PROCESS. COMPLICATIONS WITHIN THE STUDY INCLUDED FEVER IN 11 CASES, URINARY TRACT INFECTION IN 7 PATIENTS, WITH 6 OF THEM REQUIRING ANTIBIOTICS TREATMENT; 18 PATIENTS REQUIRED BLOOD TRANSFUSIONS, 4 CASES WERE A URETEROSCOPY WAS REQUIRED, 5 PATIENTS THAT EXPERIENCED URINARY LEAKAGE AND ALSO, 2 PATIENTS REQUIRED SELECTIVE ANGIOEMBOLIZATION DUE TO UNCONTROLLABLE BLEEDING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN BMC UROLOGY THAT A STUDY WAS CONDUCTED TO COMPARE CONVENTIONAL SEQUENTIAL AMPLATZ DILATATION (SAD) USING TEN DILATORS AND A METHOD USING THREE DILATORS (3SD). THE STUDY INCLUDED DATA FROM 283 PATIENTS, BEING 138 IN THE 3SD GROUP AND 145 IN THE SAD GROUP; THE CASES OCCURRED BETWEEN 2012 AND 2022. IT WAS SAID THAT AN INTRODUCER PERCUNTANEOUS NEEDLE AND AN AMPLATZ ACCESS SHEATH WERE INTRODUCED IN THE PRONE POSITION AS PART OF THE DILATATION PROCESS. COMPLICATIONS WITHIN THE STUDY INCLUDED FEVER IN 11 CASES, URINARY TRACT INFECTION IN 7 PATIENTS, WITH 6 OF THEM REQUIRING ANTIBIOTICS TREATMENT; 18 PATIENTS REQUIRED BLOOD TRANSFUSIONS, 4 CASES WERE A URETEROSCOPY WAS REQUIRED, 5 PATIENTS THAT EXPERIENCED URINARY LEAKAGE AND ALSO, 2 PATIENTS REQUIRED SELECTIVE ANGIOEMBOLIZATION DUE TO UNCONTROLLABLE BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1745401 NEPHROSTOMY SHEATHS AND DILATORS DILATOR, CATHETER GCC BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R