BEUDAMED
    FDA Adverse Event Death Summary report: N

    HI-TORQUE WHISPER MS GUIDE WIRE

    MDR report key: 6080823 · Received November 4, 2016

    Report

    Report Number
    2024168-2016-07636
    Event Type
    Death
    Date Received
    November 4, 2016
    Date of Event
    October 11, 2016
    Report Date
    December 7, 2016
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    UDI-DI
    08717648037818
    PMA / PMN Number
    K101116
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTIONS: AGE AT TIME OF EVENT; (B)(4) REMOVED. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. VISUAL AND DIMENSIONAL INSPECTIONS WERE PERFORMED ON THE RETURNED DEVICE. THE SEPARATION WAS CONFIRMED. THE FAILURE TO ADVANCE AND ENTRAPMENT THE DEVICE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO OTHER INCIDENTS FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. THE INVESTIGATION DETERMINED THE REPORTED FAILURE TO ADVANCE, ENTRAPMENT OF THE DEVICE, SEPARATION, FOREIGN BODY IN THE PATIENT, AND SURGICAL PROCEDURE APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE; HOWEVER A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT DEATH, AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION DETERMINED HOSPITALIZATION APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE; HOWEVER, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS OF CARDIAC ARREST AND DEATH, AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PROCEDURE WAS TO TREAT A RESTENOSED GRAFT STENT IN THE OBTUSE MARGINAL ARTERY. THE WHISPER GUIDE WIRE WAS ADVANCED, BUT IT WAS DIFFICULT TO ADVANCE THROUGH THE RE-STENOSIS. THE GUIDE WIRE WAS TO BE RETRACTED FOR RE-POSITIONING BUT BECAME HUNG UP ON THE PROXIMAL END OF THE STENT IMPLANT AND THE DISTAL END OF THE GUIDE WIRE TIP SEPARATED. THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY TO SNARE THE SEPARATED GUIDE WIRE TIP. HOWEVER, THE SEPARATED TIP WAS NOT REMOVED FROM THE PATIENT ANATOMY DURING SURGERY. THE PATIENT DIED THE SAME DAY, 20 MINUTES AFTER SURGERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUS VOLUNTARY EVENT REPORT RECEIVED STATES: DURING CARDIAC CATH/PCI, THE GUIDEWIRE BECAME FIXED WITHIN A PREVIOUSLY PLACED STENT. INTERVENTIONAL RADIOLOGIST GENTLY WITHDREW THE GUIDEWIRE THEN NOTED ON FLUOROSCOPY, THE TIP OF THE GUIDEWIRE HAD SEPARATED AND WAS EMBEDDED AND FIXED IN STENT STRUT. THAT THE PATIENT WAS TRANSFERRED TO A UNIVERSITY SETTING FOR EXTRACTION OF THE GUIDE WIRE TIP AS SOON AS BED BECAME AVAILABLE. SIX DAYS LATER ON THE MORNING OF THE PROCEDURE, THE PATIENT CODED AND EXPIRED. THE ACUTE EVENT DID NOT APPEAR TO BE RELATED TO THE RETAINED GUIDE WIRE TIP; HOWEVER, IT COULD NOT BE CONFIRMED WITH 100% CERTAINTY. AN AUTOPSY WAS NOT PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730757 HI-TORQUE WHISPER MS GUIDE WIRE GUIDE WIRES DQX AV-TEMECULA-CT 6061571 08717648037818

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death