BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PT2 GUIDE WIRE

    MDR report key: 1624259 · Received March 8, 2010

    Report

    Report Number
    2134265-2010-01405
    Event Type
    Injury
    Date Received
    March 8, 2010
    Date of Event
    January 29, 2010
    Report Date
    February 8, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MIAMI
    Product Code
    DQX
    PMA / PMN Number
    K030617
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B) (4). DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B) (4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT ARRIVED ON DOPAMINE AND HEPARIN DRIPS. VASCULAR ACCESS WAS OBTAINED VIA THE LEFT FEMORAL ARTERY. THE PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE WAS INDICATED FOR STEMI. AN UNSPECIFIED TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.3X15MM APEX BALLOON CATHETER WAS INFLATED AT 10 ATMS FOR 12 SECS AND REMOVED. A TEMP PACER WAS INSERTED VIA THE RIGHT FEMORAL VEIN. A NON-BSC THROMBECTOMY CATHETER WAS INSERTED AND MADE 1 PASS FOR 31ML OF FLUID. A TEMP PACER WAS INSERTED IN THE LEFT FEMORAL VEIN. A NON-BSC THOMBECTOMY CATHETER WAS ADVANCED TO THE RIGHT CORONARY ARTERY (RCA) AND MADE 2 PASSES FOR 31ML OF FLUID EACH TIME. A 2.3X15MM PROMUS DRUG ELUTING STENT (DES) WAS DEPLOYED AT 9 ATMS FOR 12 SEC. A 2.75X15MM QUANTUM BALLOON WAS INFLATED TWICE TO 16 ATMS FOR 15 SEC. A NON-BSC THROMBECTOMY CATHETER WAS ADVANCED INTO THE LAD WHERE THIS 2ND LAD PASS COLLECTED 25ML OF FLUID. THE PT2-MS GUIDE WIRE WAS ADVANCED TO THE DIAGONAL (DIAG) ARTERY. A 3X12MM PROMUS DES WAS ADVANCED IN THE DIAG ARTERY BUT REMOVED INTACT. A 3X12MM NON-BSC BALLOON WAS ADVANCED AND REMOVED AS WAS A 3X15MM NON-BSC BALLOON. THE 3X12MM PROMUS DES WAS READVANCED AND REMOVED AS WAS THE 3X15MM NON-BSC BALLOON AND GUIDEWIRES IN THE LAD AND DIAG. A PT2-MS GUIDEWIRE WAS ADVANCED INTO THE DIAG. THE 3X12MM PROMUS DES WAS DEPLOYED IN THE DIAG AT 9 ATMS FOR 25 SEC. A 3.5MM PROMUS DES WAS DEPLOYED IN THE LAD AT 9 ATMS FOR 15 SEC. THE GUIDEWIRE IN THE DIAG WAS EXCHANGED FOR A PT GRAPHIX WIRE. A 2X12MM APEX BALLOON WAS ADVANCED AND INFLATED AT 10 ATMS FOR 10 SEC. A 4X15MM QUANTUM BALLOON WAS ADVANCED INTO THE LAD AND A 3X15MM NON-BSC BALLOON WAS ADVANCED INTO THE DIAG. THE BALLOONS WERE INFLATED SIMULTANEOUSLY AT 10 ATMS FOR 20 SEC. THE PROCEDURE WAS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, A GUIDE WIRE TIP FRACTURE OCCURRED. THE TIP OF THIS PT2 MODERATE SUPPORT GUIDE WIRE CAME OFF DURING THE PROCEDURE. THE PHYSICIAN FELT THE TIP WAS TO FAR INTO THE LESION, THEREFORE NO ATTEMPT WAS MADE TO RETRIEVE THE FRACTURED TIP. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT AND THE PATIENT WAS LISTED AS DOING "FINE" POST-PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PT2 GUIDE WIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - MIAMI H74938931030

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other