BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PT²¿

    MDR report key: 7523317 · Received May 17, 2018

    Report

    Report Number
    2134265-2018-04871
    Event Type
    Injury
    Date Received
    May 17, 2018
    Date of Event
    May 9, 2018
    Report Date
    May 11, 2018
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (HEREDIA)
    Product Code
    DQX
    PMA / PMN Number
    K030617
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATED BY MFR: THE DEVICE WAS RETURNED FOR ANLAYSIS. UNIT RETURNED WITH ITS ORIGINAL BOX. THE UNIT RETURNED HAS TIP BENT. THE DEVICE HAS ITS DISTAL TIP KINKED AND HAS ITS DISTAL END PEELED OFF. IT ALSO PRESENTS A KINK ON ITS PROXIMAL SECTION. OUTER DIAMETER OF MIDDLE OF THE DEVICE AND PROXIMAL SECTION ARE WITHIN SPECIFICATIONS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE INVESTIGATION CONCLUSION IS OPERATIONAL CONTEXT AS THE PRODUCT MEETS THE DESIGN & MANUFACTURE SPECIFICATION BUT DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, PERFORMANCE WAS LIMITED. (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE GUIDE WIRE FRACTURED OCCURRED. A 185CM PT, J-TIP GUIDE WIRE WAS ADVANCED TO THE LESION. HOWEVER, IT WAS NOTED THAT THE DISTAL SEGMENT OF THE GUIDE WIRE WAS FRACTURED. TO IMPRISON THE FRACTURED SEGMENT, THE PHYSICIAN THEN IMPLANTED A STENT AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). DEVICE EVALUATED BY MFR.: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GUIDE WIRE FRACTURED OCCURRED. A 185 CM PT²¿, J-TIP GUIDE WIRE WAS ADVANCED TO THE LESION. HOWEVER, IT WAS NOTED THAT THE DISTAL SEGMENT OF THE GUIDE WIRE WAS FRACTURED. TO IMPRISON THE FRACTURED SEGMENT, THE PHYSICIAN THEN IMPLANTED A STENT AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364321 PT²¿ WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) H7493893103J0 19806985

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention