BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATINUM PLUS

    MDR report key: 8703897 · Received June 17, 2019

    Report

    Report Number
    2134265-2019-07004
    Event Type
    Malfunction
    Date Received
    June 17, 2019
    Date of Event
    June 11, 2019
    Report Date
    October 4, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQX
    UDI-DI
    08714729114567
    PMA / PMN Number
    K935997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATED BY MFR.: THE GUIDEWIRE RETURNED WITH THE PROXIMAL SECTION STUCK IN A PCB 2CM DEVICE. MOREOVER, THE DEVICE RETURNED DETACHED IN THREE SECTIONS INCLUDING THE SECTION STUCK ON THE PCB 2CM DEVICE. ADDITIONALLY, THE GUIDEWIRE WAS RETURNED PEELED AT THE DISTAL SECTION AND WITH THE SPRING TIP KINKED. THE OUTER DIAMETER DIMENSIONS WERE FOUND WITHIN SPECIFICATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON BECAME STUCK ON THE GUIDE WIRE. THE TARGET LESION WAS LOCATED IN THE INNOMINATE VEIN. A 3 018/180 PLATINUM PLUS GUIDEWIRE AN A 2CM PERIPHERAL CUTTING BALLOON (PCB) WERE USED IN A PROCEDURE. WHEN THE PHYSICIAN PULLED THE PBC OUT OF THE SHEATH, THE TIP OF THE SHEATH BECAME DAMAGED AND THE BALLOON WAS STUCK. THE PHYSICIAN PULLED EVERYTHING OUT AND MANAGED TO KEEP THE WIRE ACCESS, BUT THE PHYSICIAN HAD TO CUT THE WIRE BECAUSE IT BECAME STUCK WITH THE BALLOON. THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT COMPLICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BALLOON BECAME STUCK ON THE GUIDE WIRE. THE TARGET LESION WAS LOCATED IN THE INNOMINATE VEIN. A 3 018/180 PLATINUM PLUS GUIDEWIRE AN A 2CM PERIPHERAL CUTTING BALLOON (PCB) WERE USED IN A PROCEDURE. WHEN THE PHYSICIAN PULLED THE PBC OUT OF THE SHEATH, THE TIP OF THE SHEATH BECAME DAMAGED AND THE BALLOON WAS STUCK. THE PHYSICIAN PULLED EVERYTHING OUT AND MANAGED TO KEEP THE WIRE ACCESS, BUT THE PHYSICIAN HAD TO CUT THE WIRE BECAUSE IT BECAME STUCK WITH THE BALLOON. THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499101 PLATINUM PLUS WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC CORPORATION 39935 0022593559 08714729114567

    Patients

    Seq Age Sex Outcome Treatment
    1