BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PT²?

    MDR report key: 3100405 · Received May 8, 2013

    Report

    Report Number
    2134265-2013-03286
    Event Type
    Injury
    Date Received
    May 8, 2013
    Report Date
    April 10, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    DQX
    PMA / PMN Number
    K030617
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS: UNDETERMINABLE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, A GUIDE WIRE BREAK OCCURRED. THE PATIENT PRESENTED WITH AN ST ELEVATION MYOCARDIAL INFARCTION. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. THE PROCEDURE WAS BEING PERFORMED AS A BRIDGE TO CORONARY ARTERY BYPASS GRAFTING. A 185CM J-TIP PT2 MODERATE SUPPORT GUIDEWIRE CATHETER WAS SELECTED AND ADVANCED TO THE TARGET LESION. THE DISTAL TIP WAS LOOPED. UPON PULLING BACK THE GUIDE WIRE TO UNDO THE LOOP, THE DISTAL 20MM OF THE GUIDE WIRE BROKE. THE DISTAL TIP OF THE GUIDE WIRE WAS NOT RETRIEVED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE A GUIDE WIRE BREAK OCCURRED. THE PATIENT PRESENTED WITH AN ST ELEVATION MYOCARDIAL INFARCTION. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. THE PROCEDURE WAS BEING PERFORMED AS A BRIDGE TO CORONARY ARTERY BYPASS GRAFTING. A 185CM J-TIP PT2 MODERATE SUPPORT GUIDEWIRE CATHETER WAS SELECTED AND ADVANCED TO THE TARGET LESION. THE DISTAL TIP WAS LOOPED. UPON PULLING BACK THE GUIDE WIRE TO UNDO THE LOOP, THE DISTAL 20MM OF THE GUIDE WIRE BROKE. THE DISTAL TIP OF THE GUIDE WIRE WAS NOT RETRIEVED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201657 PT²? WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA (COYOL) H7493893103J0

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention