BEUDAMED
    FDA Adverse Event Death Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE

    MDR report key: 2974870 · Received February 22, 2013

    Report

    Report Number
    2024168-2013-01060
    Event Type
    Death
    Date Received
    February 22, 2013
    Date of Event
    January 22, 2013
    Report Date
    February 5, 2016
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K072460
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. IT SHOULD BE NOTED THE HI-TORQUE GUIDE WIRES INSTRUCTIONS FOR USE STATES: IF THE SURFACE OF THE HYDROPHILIC-COATED WIRE BECOMES DRY, WETTING THE SURFACE WITH NORMAL SALINE WILL RENEW THE HYDROPHILIC EFFECT. BE SURE TO THOROUGHLY REWET THE GUIDE WIRE BEFORE REINTRODUCTION INTO AN INTERVENTIONAL DEVICE. BASED ON THE INFORMATION PROVIDED AND WITHOUT THE PRODUCT TO EXAMINE, A DEFINITIVE CAUSE FOR THE REPORTED DIFFICULTIES CANNOT BE DETERMINED; HOWEVER THERE IS NO INDICATION TO SUGGEST A PRODUCT QUALITY DEFICIENCY. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES AND PATIENT EFFECTS. PER THE HI-TORQUE GUIDE WIRES INSTRUCTIONS FOR USE SURGICAL PROCEDURE AND DEATH ARE POTENTIAL PROCEDURAL COMPLICATIONS. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES AND PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL/FINAL MEDWATCH REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: ON (B)(4) 2013, THE GUIDEWIRE SEPARATED IN THE PATIENT. THE PATIENT WENT TO SURGERY (B)(6) 2013 FOR CORONARY ARTERY BYPASS AND GUIDE WIRE REMOVAL. IT WAS NOTED THAT HAD THE WIRE NOT SEPARATED THE PATIENT WOULD NOT HAVE GONE TO SURGERY. DURING SURGERY THE WIRE FRAGMENT WAS CUT AT THE ENTRANCE OF THE CORONARY ARTERY BUT WAS NOT REMOVED FROM THE VESSEL. A FEW DAYS LATER AFTER TWO SURGERIES THE PATIENT DIED FROM SEPTIC SHOCK WHICH WAS CONSIDERED COMPLICATIONS OF THE SURGERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A COMPLEX AND LENGTHY PROCEDURE OF THE RIGHT CORONARY ARTERY (RCA), THE BALANCE MIDDLEWEIGHT UNIVERSAL II (BMWUII) GUIDE WIRE WAS BEING USED AS A BUDDYWIRE IN COMBINATION WITH A HI-TORQUE EXTRA SUPPORT GUIDE WIRE. THE BMWUII BECAME STUCK DURING REMOVAL AND THE GUIDE WIRE SEPARATED. THE PATIENT WAS REFERRED TO SURGERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78838 HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| R