BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE ACTION PUMPING SYSTEM CONTINUOUS FLOW

    MDR report key: 21194246 · Received January 20, 2025

    Report

    Report Number
    2124215-2025-01479
    Event Type
    Injury
    Date Received
    January 20, 2025
    Date of Event
    May 19, 2015
    Report Date
    January 20, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KOD
    UDI-DI
    08714729045076
    PMA / PMN Number
    K870557
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: DATE OF EVENT: APPROXIMATED TO MAY 19, 2015, AS TO WHEN THE LITERATURE REPORT WAS PUBLISHED. BLOCK H6: PATIENT CODE (B)(6) CAPTURES THE REPORTABLE EVENT OF PAIN. IMPACT CODE F2303 CAPTURES THE REPORTABLE EVENT OF MEDICATION REQUIRED. BLOCK G2 (REPORT SOURCE): ALAZEM, K., LI, I., & MONGA, M. (20215). PREDICTING PROCEDURAL PAIN AFTER URETEROSCOPY: DOES HYDRODISTENTION PLAY A ROLE? JOURNAL OF INT BRAZ J UROL, 2016; 42: 734-9, HTTPS://DOI.ORG/10.1590/S1677-5538.IBJU.2015.0275

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC THE STUDY PUBLISHED IN THE INTERNATIONAL BRAZILIAN JOURNAL OF UROLOGY AIMED TO IDENTIFY PERIOPERATIVE PREDICTORS OF IMMEDIATE PAIN FOLLOWING URETEROSCOPY, WITH A SPECIFIC FOCUS ON WHETHER HYDRODISTENTION (FROM PRESSURIZED IRRIGATION) OF THE RENAL COLLECTING SYSTEM CONTRIBUTES TO POST-PROCEDURE PAIN, WHERE AN IRRIGATION SYRING UNIT WAS USED. A TOTAL OF 131 PATIENTS WERE INCLUDED IN THE STUDY WHO UNDERWENT URETEROSCOPY FOR STONE TREATMENT, WITH EQUAL GENDER DISTRIBUTION. AN UNSPECIFIED AMOUNT OF PATIENT EXPERIENCED PAIN THAT REQUIRED NARCOTICS UPON POST-ANESTHESIA CARE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556554 SINGLE ACTION PUMPING SYSTEM CONTINUOUS FLOW CATHETER, UROLOGICAL KOD BOSTON SCIENTIFIC CORPORATION 08714729045076

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other