BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTIVATOR COLD SINGLE-USE SNARE

    MDR report key: 17481406 · Received August 8, 2023

    Report

    Report Number
    3005099803-2023-04106
    Event Type
    Malfunction
    Date Received
    August 8, 2023
    Date of Event
    June 19, 2023
    Report Date
    August 9, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGX
    UDI-DI
    08714729971252
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D4, H4: THE SUSPECT DEVICE LOT NUMBER IS NOT PROVIDED; THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. BLOCK G2: REPORT SOURCE: MEDWATCH# (B)(4). BLOCK H6: IMDRF DEVICE CODE A150208 CAPTURES THE REPORTABLE EVENT OF LOOP ENTRAPMENT ON PATIENT'S TISSUE. IMDRF DEVICE CODE A050702 CAPTURES THE REPORTABLE EVENT OF LOOP CUTTING ISSUE.

    Additional Manufacturer Narrative · 0

    BLOCK D4, H4: THE SUSPECT DEVICE LOT NUMBER IS NOT PROVIDED; THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. BLOCK H6: IMDRF DEVICE CODE A150208 CAPTURES THE REPORTABLE EVENT OF LOOP ENTRAPMENT ON PATIENT'S TISSUE. IMDRF DEVICE CODE A050702 CAPTURES THE REPORTABLE EVENT OF LOOP CUTTING ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A 10MM ROUND COLD SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE DEVICE WOULD NOT RETRACT BACK INTO THE CATHETER, THE DEVICE WOULD NOT SNARE THE POLYP, AND THE SNARE WAS STUCK ON THE PATIENT'S TISSUE/POLYP. THE SNARE WAS ALSO BENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A 10MM ROUND COLD SNARE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE DEVICE WOULD NOT RETRACT BACK INTO THE CATHETER, THE DEVICE WOULD NOT SNARE THE POLYP, AND THE SNARE WAS STUCK ON THE PATIENT'S TISSUE/POLYP. THE SNARE WAS ALSO BENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2317960 CAPTIVATOR COLD SINGLE-USE SNARE SNARE, NON-ELECTRICAL FGX BOSTON SCIENTIFIC CORPORATION M00561100 08714729971252

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female