BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE

    MDR report key: 2807645 · Received October 29, 2012

    Report

    Report Number
    2024168-2012-06827
    Event Type
    Injury
    Date Received
    October 29, 2012
    Date of Event
    October 4, 2012
    Report Date
    October 4, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K103101
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THERE WAS NO REPORTED PRODUCT DEFICIENCY AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECT OF VESSEL TRAUMA (PERFORATION), AS LISTED IN THE HI-TORQUE BALANCE MIDDLEWEIGHT (BMW) ELITE GUIDE WIRE INSTRUCTIONS FOR USE (IFU), IS A KNOWN ADVERSE EVENT WITH THE USE OF GUIDE WIRES. 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, DESIGN OR LABELING. THE ADDITIONAL THERAPY/NON-SURGICAL TREATMENT APPEARS TO BE RELATED TO CASE-SPECIFIC OPERATIONAL CONTEXT AS A NON-COMPLIANT BALLOON WAS USED TO FULLY APPOSE THE STENT TO THE VESSEL WALL AND RESTORE FLOW. THE PATIENT WAS ALSO GIVEN MEDICATION AND PUT ON A BALLOON PUMP. THE PERFORATION RESOLVED WITHOUT ANY FURTHER TREATMENT. THE ADDITIONAL BMW ELITE AND XIENCE PRIME REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH REPORTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION AT THE BIFURCATION OF THE LEFT ANTERIOR DESCENDING (LAD) ARTERY AND THE DIAGONAL BRANCH. THE VESSEL WAS HEAVILY TORTUOUS, WITH HEAVY CALCIFICATION. TWO BALANCE MIDDLEWEIGHT (BMW) ELITE GUIDE WIRES (LOT#2061801) WERE ADVANCED, WITH ONE IN THE LAD AND ONE IN THE DIAGONAL. THE LAD LESION WAS PRE-DILATED AND A XIENCE PRIME STENT WAS DEPLOYED, THEN POST-DILATED WITH A NON-COMPLIANT BALLOON. A THIRD BMW ELITE GUIDE WIRE (LOT#2062001) WAS ADVANCED ACROSS THE STENT; HOWEVER, THE GUIDE WIRE CAUSED A PERFORATION IN THE DIAGONAL VESSEL. THE PERFORATION RESOLVED ITSELF WITHIN A FEW MINUTES. THE BMW GUIDE WIRE IN THE DIAGONAL VESSEL WAS ATTEMPTED TO BE REMOVED, BUT WAS JAILED BY THE STENT. FORCE WAS USED, BUT THE GUIDE WIRE COULD NOT BE REMOVED. A MICRO-CATHETER WAS ADVANCED BEHIND THE STENT TO REMOVE THE WIRE, WHICH WAS SUCCESSFUL; HOWEVER, THE DIAGONAL VESSEL BECAME OCCLUDED AND THE STENT WAS NO LONGER FULLY APPOSED TO THE VESSEL WALL. IT WAS NOTED THAT THROMBUS WAS FORMING IN THE LAD. THE SAME NON-COMPLIANT BALLOON WAS USED AGAIN TO FULLY APPOSE THE STENT TO THE VESSEL WALL. THE FLOW WAS RESTORED IN BOTH THE LAD AND DIAGONAL VESSELS. THE PATIENT WAS GIVEN MEDICATION AND PUT ON A BALLOON PUMP. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT 2062001

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GUIDE CATH: FINECROSS