BEUDAMED
    FDA Adverse Event Death Summary report: N

    DAKOTA

    MDR report key: 20019683 · Received August 21, 2024

    Report

    Report Number
    2124215-2024-50270
    Event Type
    Death
    Date Received
    August 21, 2024
    Date of Event
    January 29, 2023
    Report Date
    September 18, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FFL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AKGUL, M., CAKIR, H., CINAR, O., OZMAN, O., BASATAC, C., SIDDIKOGLU, D., DOGAN, C., BASESKIOGLU, A. B., YAZICI, C. M., SANCAK, E., AKPINAR, H., & ONAL, B. (2023). THE EFFICACY AND SAFETY OF RETROGRADE INTRARENAL SURGERY: A MULTI-CENTER EXPERIENCE OF THE RIRSEARCH GROUP STUDY. JOURNAL OF UROLOGICAL SURGERY, 10(2), 119-128. HTTPS://DOI.ORG/10.4274/JUS.GALENOS.2023.2022.0039. B2 DATE OF DEATH AND B3 DATE OF EVENT: EXACT DATES UNKNOWN, PUBLISH DATE HAS BEEN USED INSTEAD. H6 PATIENT CODES HAVE BEEN UPDATED.

    Additional Manufacturer Narrative · 0

    AKGUL, M., CAKIR, H., CINAR, O., OZMAN, O., BASATAC, C., SIDDIKOGLU, D., DOGAN, C., BASESKIOGLU, A. B., YAZICI, C. M., SANCAK, E., AKPINAR, H., & ONAL, B. (2023). THE EFFICACY AND SAFETY OF RETROGRADE INTRARENAL SURGERY: A MULTI-CENTER EXPERIENCE OF THE RIRSEARCH GROUP STUDY. JOURNAL OF UROLOGICAL SURGERY, 10(2), 119-128. HTTPS://DOI.ORG/10.4274/JUS.GALENOS.2023.2022.0039 B2 DATE OF DEATH AND B3 DATE OF EVENT: EXACT DATES UNKNOWN, PUBLISH DATE HAS BEEN USED INSTEAD.

    Additional Manufacturer Narrative · 0

    AKGUL, M., CAKIR, H., CINAR, O., OZMAN, O., BASATAC, C., SIDDIKOGLU, D., DOGAN, C., BASESKIOGLU, A. B., YAZICI, C. M., SANCAK, E., AKPINAR, H., & ONAL, B. (2023). THE EFFICACY AND SAFETY OF RETROGRADE INTRARENAL SURGERY: A MULTI-CENTER EXPERIENCE OF THE RIRSEARCH GROUP STUDY. JOURNAL OF UROLOGICAL SURGERY, 10(2), 119-128. HTTPS://DOI.ORG/10.4274/JUS.GALENOS.2023.2022.0039. B2 DATE OF DEATH: THE DATE OF DEATH WAS NOT PROVIDED, BUT IT IS PROBABLE THAT IT OCCURED BETWEEN 2016 AND 2021, WHICH IS THE TIMEFRAME USED IN THE STUDY. B3 DATE OF EVENT: CORRECTED, EXACT DATE UNKNOWN, PUBLISH DATE HAS BEEN USED INSTEAD.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN THE JOURNAL OF UROLOGICAL SURGERY THAT A STUDY WAS CONDUCTED TO ASSESS THE EFFICACY AND SAFETY OF RETROGRADE INTRARENAL SURGERIES (RIRS), INVOLVING A DAKOTA BASKET TO EXTRACT STONE FRAGMENTS LARGER THAN 2 MM AND A SENSOR WIRE TO PERFORM A CYSTOSCOPY AND RETROGRADE PYELOGRAPHY EVALUATION. THE STUDY CONSISTED OF 1067 PATIENTS THAT UNDERWENT RIRS PROCEDURES BETWEEN 2016 AND 2021, WHERE 59.8% WERE MALES AND 40.2% WERE FEMALES. IT WAS STATED THAT ONE OF THE PATIENTS EXPERIENCED FEVER, PANCYTOPENIA, AND HEPATOSPLENOMEGALY THAT WAS DIAGNOSED WITH HEMOPHAGOCYTIC SYNDROME. THIS PATIENT DIED FROM MULTIORGAN FAILURE DURING THE POSTOPERATIVE THIRD WEEK OF THE RIRS. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN THE JOURNAL OF UROLOGICAL SURGERY THAT A STUDY WAS CONDUCTED TO ASSESS THE EFFICACY AND SAFETY OF RETROGRADE INTRARENAL SURGERIES (RIRS), INVOLVING A DAKOTA BASKET TO EXTRACT STONE FRAGMENTS LARGER THAN 2 MM AND A SENSOR WIRE TO PERFORM A CYSTOSCOPY AND RETROGRADE PYELOGRAPHY EVALUATION. THE STUDY CONSISTED OF 1067 PATIENTS THAT UNDERWENT RIRS PROCEDURES BETWEEN 2016 AND 2021, WHERE 59.8% WERE MALES AND 40.2% WERE FEMALES. IT WAS STATED THAT ONE OF THE PATIENTS EXPERIENCED FEVER, PANCYTOPENIA, AND HEPATOSPLENOMEGALY THAT WAS DIAGNOSED WITH HEMOPHAGOCYTIC SYNDROME. THIS PATIENT DIED FROM MULTIORGAN FAILURE DURING THE POSTOPERATIVE THIRD WEEK OF THE RIRS. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC VIA AN ARTICLE PUBLISHED IN THE JOURNAL OF UROLOGICAL SURGERY THAT A STUDY WAS CONDUCTED TO ASSESS THE EFFICACY AND SAFETY OF RETROGRADE INTRARENAL SURGERIES (RIRS), INVOLVING A DAKOTA BASKET TO EXTRACT STONE FRAGMENTS LARGER THAN 2 MM AND A SENSOR WIRE TO PERFORM A CYSTOSCOPY AND RETROGRADE PYELOGRAPHY EVALUATION. THE STUDY CONSISTED OF 1067 PATIENTS THAT UNDERWENT RIRS PROCEDURES BETWEEN 2016 AND 2021, WHERE 59.8% WERE MALES AND 40.2% WERE FEMALES. IT WAS STATED THAT ONE OF THE PATIENTS EXPERIENCED FEVER, PANCYTOPENIA, AND HEPATOSPLENOMEGALY THAT WAS DIAGNOSED WITH HEMOPHAGOCYTIC SYNDROME. THIS PATIENT DIED FROM MULTIORGAN FAILURE DURING THE POSTOPERATIVE THIRD WEEK OF THE RIRS. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1397186 DAKOTA DISLODGER, STONE, BASKET, URETERAL, METAL FFL BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death