BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PT GRAPHIX?

    MDR report key: 3243496 · Received July 23, 2013

    Report

    Report Number
    2134265-2013-04940
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 26, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    DQX
    PMA / PMN Number
    K965023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: 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 REPORTED THAT POST PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, VESSEL PERFORATION OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA RIGHT FEMORAL ARTERY. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA) WITH REFERENCE VESSEL DIAMETER OF 3.0MM AND LENGTH OF 38MM AND 34MM. A 182CM PT GRAPHIX GUIDE WIRE WAS SELECTED TO ADVANCE TO THE LESION FOLLOWED BY A NON-BSC GUIDE CATHETER AND PREDILATED WITH A NON-BSC BALLOON CATHETER THEN 2 NON-BSC STENTS WERE IMPLANTED TO THE LESION. AFTER PROCEDURE, THE PATIENT LOOKED FINE THEN LATER ON DEVELOPED A HOMEOPERICARD WITH HYPOTENSION AND PAIN IN THE BACK. A PERICARDIOCENTESIS WAS PERFORMED AND DRAINED 350ML OF FRESH BLOOD. THE PATIENT WAS THEN TRANSFERRED TO THE INTENSIVE CARE UNIT IN ANOTHER HOSPITAL AND SEEMS TO BE FINE. THE PHYSICIAN THINKS THAT HE DID A PERFORATION WITH THE WIRE WITHOUT NOTICING, HE SAID THAT HE REVIEWED THE IMAGES BUT CANNOT SEE AT WHAT TIME AND SEES NO PERFORATION. NO FURTHER COMPLICATION WAS REPORTED AND PATIENT'S CONDITION WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343195 PT GRAPHIX? WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA (COYOL) H74914902011

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R