BEUDAMED
    FDA Adverse Event Death Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE

    MDR report key: 1833442 · Received August 30, 2010

    Report

    Report Number
    2024168-2010-01796
    Event Type
    Death
    Date Received
    August 30, 2010
    Date of Event
    August 6, 2010
    Report Date
    August 12, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES - P.R.
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. A F/U REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    INTERNAL FILE NUMBER - (B)(4). THE REPORTED PATIENT EFFECT OF PERFORATION (VESSEL DAMAGE), AS LISTED M THE HI-TORQUE BALANCE MIDDLE WEIGHT (BMW) UNIVERSAL GUIDE WIRE INSTRUCTIONS FOR USE, IS A KNOWN ADVERSE EVENT ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE AND DESIGN.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT: PERFORATION/DEATH. ONSET OF ADVERSE EVENT: DURING AND POST-PROCEDURE. IT WAS REPORTED THAT ON (B)(6)2010, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) WAS PERFORMED TO TREAT A LESION THAT HAD DIFFUSE DISEASE LOCATED AT THE PROXIMAL TO MID OBTUSE MARGINAL (OM). THE BMW UNIVERSAL GUIDE WIRE WAS PLACED IN THE OM AND THE CASE WAS COMPLETED SUCCESSFULLY. AFTER THE CASE, THE PT WAS FOUND HYPOTENSIVE. THROUGH DIAGNOSING, A PERFORATION WAS OBSERVED IN THE DISTAL OM. THERE WAS A PERICARDIAL TAMPONADE AND A PERICARDIOCENTESIS WAS PERFORMED AS WELL AS USING A COIL, MEDICATIONS, AND AN IABP CATHETER AS SUPPORT. THE PT WAS THEN TRANSFERRED TO THE CRITICAL CARE UNIT FOR MONITORING WHERE A BLOOD TRANSFUSION WAS DONE AS WELL AS ADDITIONAL MEDICATIONS TO MAINTAIN BLOOD PRESSURE. ON (B)(6)2010, THE IABP CATHETER WAS REMOVED. ON (B)(6)2010, THERE WAS A THORACENTESIS AND VARIOUS MEDICATIONS ADMINISTERED TO RAISE THE PT'S BLOOD PRESSURE, AS WELL AS A TRACHEAL INTUBATION AND A PACEMAKER IMPLANTATION. HOWEVER, THE PT'S BLOOD PRESSURE AND HEART RATE COULD NOT BE MAINTAINED AND THE PT EXPIRED FROM HEART FAILURE AND CARCINOGENIC SHOCK. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE DQX ABBOTT VASCULAR-CARDIAC THERAPIES - P.R. NA 0040788

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Death UNK.