BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PT GRAPHIX

    MDR report key: 12511037 · Received September 21, 2021

    Report

    Report Number
    2134265-2021-11321
    Event Type
    Injury
    Date Received
    September 21, 2021
    Date of Event
    August 1, 2021
    Report Date
    October 5, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQX
    UDI-DI
    08714729141723
    PMA / PMN Number
    K143587
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    B2. DATE OF EVENT: USED THE FIRST DAY OF THE MONTH OF THE AWARE DATE AS BEST ESTIMATE AS THERE WAS NO INFORMATION PROVIDED. DEVICE EVALUATED BY MFR. : UNIT RETURNED WITH ITS ORIGINAL POUCH BATCH 24578592. THE RETURNED DEVICE MATCHES WITH UPN AND LOT PROVIDED BY THE CUSTOMER. THE RETURNED GUIDEWIRES SPRING TIP WAS BENT/KINK AND UNRAVELED. THE GUIDEWIRE HAD A KINK AT 0.5" SECTION FROM THE PROXIMAL END, AND ALSO AT THE 35" SECTION FROM THE PROXIMAL END. THE DEVICE WAS MEASURED IN THREE SECTIONS (DISTAL - MEDIUM - PROXIMAL) ALL WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE CALCIFIED OBTUSE MARGINAL (OM). A CHOICE GRAPHIX PT INTERMEDIATE GUIDEWIRE WAS USED; HOWEVER, DURING REMOVAL, A PIECE OF THE TIP BROKE OFF IN THE OM. THE PHYSICIAN MADE SEVERAL ATTEMPTS TO SNARE THE FRACTURED PORTION BUT WAS UNABLE TO REACH IT. THE PHYSICIAN DECIDED TO LEAVE THE FRACTURED PORTION IN THE OM AS HERE WAS NO FEAR OF PATIENT HARM. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FULLY RECOVERED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: USED THE FIRST DAY OF THE MONTH OF THE AWARE DATE AS BEST ESTIMATE AS THERE WAS NO INFORMATION PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE CALCIFIED OBTUSE MARGINAL (OM). A CHOICE GRAPHIX PT INTERMEDIATE GUIDEWIRE WAS USED; HOWEVER, DURING REMOVAL, A PIECE OF THE TIP BROKE OFF IN THE OM. THE PHYSICIAN MADE SEVERAL ATTEMPTS TO SNARE THE FRACTURED PORTION BUT WAS UNABLE TO REACH IT. THE PHYSICIAN DECIDED TO LEAVE THE FRACTURED PORTION IN THE OM AS HERE WAS NO FEAR OF PATIENT HARM. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FULLY RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1407974 PT GRAPHIX WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC CORPORATION 2480 0024578592 08714729141723

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R