BEUDAMED
    FDA Adverse Event Death Summary report: N

    OMNIWIRE PRESSURE GUIDE WIRE

    MDR report key: 20156030 · Received September 6, 2024

    Report

    Report Number
    3008363989-2024-00051
    Event Type
    Death
    Date Received
    September 6, 2024
    Date of Event
    August 27, 2024
    Report Date
    September 25, 2024
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    DQX
    UDI-DI
    00845225003043
    PMA / PMN Number
    K192886
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B5: EVENT DESCRIPTION HAS BEEN UPDATED PER THE PHILIPS CLINICAL ASSESSMENT. THE CODES SELECTED IN THE INITIAL MDR REMAIN THE SAME. SUBMISSION OF THIS REPORT DOES NOT, IN ITSELF, REPRESENT A CONCLUSION BY THE MANUFACTURER AND/OR AUTHORIZED REPRESENTATIVE OR THE NATIONAL COMPETENT AUTHORITY THAT THE CONTENT OF THIS REPORT IS COMPLETE OR ACCURATE, THAT THE MEDICAL DEVICE(S) LISTED FAILED IN ANY MANNER AND/OR THAT THE MEDICAL DEVICE(S) CAUSED OR CONTRIBUTED TO AN ALLEGED DEATH OR DETERIORATION IN THE STATE OF THE HEALTH OF ANY PERSON.

    Additional Manufacturer Narrative · 0

    THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER¿S POLICY. BLOCKS A2, A3B-4: DATE OF BIRTH AND GENDER NOT PROVIDED. BLOCK C: NOT APPLICABLE FOR THIS DEVICE. BLOCK D4: SERIAL NUMBER IS UNKNOWN. BLOCKS D6 & D7: NOT APPLICABLE FOR THIS DEVICE. BLOCKS E1 & G2: COUNTRY IS GERMANY. BLOCK H3: THE OMNIWIRE WAS NOT RETURNED FOR EVALUATION, THUS NO RETURNED PRODUCT INVESTIGATION WAS PERFORMED. BLOCK H6: BASED ON THE PHILIPS CLINICAL ASSESSMENT, THE CAUSE OF THE DISSECTION IS LIKELY USE ERROR AS THE REPORT INDICATES THAT THE WIRE WAS PUSHED AGAINST RESISTANCE. THE IFU PRECAUTIONS: IN ORDER TO MINIMIZE PATIENT RISK, EXERCISE CAUTION WHEN USING THE PRESSURE GUIDE WIRE IN A STENTED VESSEL. WHEN ADVANCING OR WITHDRAWING THE PRESSURE GUIDE WIRE IN A STENTED VESSEL, IN THE EVENT THAT THE STENT IS NOT FULLY APPOSED AGAINST THE VESSEL WALL, THE PRESSURE GUIDE WIRE MAY BECOME ENTANGLED IN ONE OR MORE STENT STRUTS. THIS MAY RESULT IN ENTRAPMENT OF THE PRESSURE GUIDE WIRE, DAMAGE TO THE PRESSURE GUIDE WIRE AND/OR STENT DISLOCATION. THE PRESSURE GUIDE WIRE SHOULD NOT BE ADVANCED OR WITHDRAWN IF RESISTANCE IS ENCOUNTERED. THE WIRE SHOULD NEVER BE FORCIBLY ADVANCED INTO OR WITHDRAWN FROM A VESSEL. ANY TIME THAT RESISTANCE IS ENCOUNTERED, THE WIRE SHOULD BE SLOWLY WITHDRAWN UNDER FLUOROSCOPIC GUIDANCE. BLOCKS H7 & H9: DO NOT APPLY TO THIS SUBMISSION. SUBMISSION OF THIS REPORT DOES NOT, IN ITSELF, REPRESENT A CONCLUSION BY THE MANUFACTURER AND/OR AUTHORIZED REPRESENTATIVE OR THE NATIONAL COMPETENT AUTHORITY THAT THE CONTENT OF THIS REPORT IS COMPLETE OR ACCURATE, THAT THE MEDICAL DEVICE(S) LISTED FAILED IN ANY MANNER AND/OR THAT THE MEDICAL DEVICE(S) CAUSED OR CONTRIBUTED TO AN ALLEGED DEATH OR DETERIORATION IN THE STATE OF THE HEALTH OF ANY PERSON.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN OMNIWIRE WAS USED IN A THERAPEUTIC CORONARY PROCEDURE IN A RAMUS AND LCX. AFTER ANGIO, RAMUS AND LCX WERE TREATED WITH A STENT (PROMUS 2.75X16 AND 2.75X20). THEN, THE OMNIWIRE WAS ADVANCED THROUGH A NON-PHILIPS GUIDE CATHETER INTO THE RAMUS FOR CONTROL. RESISTANCE WAS ENCOUNTERED IN THE AREA OF THE PREVIOUSLY PLACED STENT, AND GOT CAUGHT IN THE STENT MESH WITH THE TIP AND COULD NO LONGER BE REMOVED. THE GUIDE CATHETER WAS PULLED FURTHER AND FURTHER INTO THE LEFT MAIN CORONARY ARTERY BY THE TRAPPED WIRE AND CAUSED A DISSECTION OF THE CALCIFIED LAD, RESULTING IN PATIENT DEATH. UNDER ANGIO, THERE WAS NO PHYSICAL DAMAGE OR PROTRUDING PARTS OBSERVED ON THE WIRE. ALL PORTIONS OF THE WIRE APPEAR TO BE ACCOUNTED FOR WHEN IT WAS REMOVED FROM THE PATIENT POST-MORTEM. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED DUE TO ENTRAPMENT, AND THE ATTEMPT TO REMOVE THE WIRE CAUSING AN LAD DISSECTION, RESULTING IN PATIENT'S DEATH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN OMNIWIRE WAS USED IN A THERAPEUTIC CORONARY PROCEDURE IN A SEVERELY CALCIFIED MID LAD. AFTER ANGIO, THE RIVA (RAMUS INTERVENTRICULARIS ANTERIOR) AND RCX WERE TREATED WITH A STENT (PROMUS 2.75X16 AND 2.75X20). THEN, THE OMNIWIRE WAS ADVANCED THROUGH A NON-PHILIPS GUIDE CATHETER INTO THE RIVA FOR CONTROL. RESISTANCE WAS ENCOUNTERED IN THE AREA OF THE PREVIOUSLY PLACED STENT, AND GOT CAUGHT IN THE STENT MESH WITH THE TIP AND COULD NO LONGER BE REMOVED. THE GUIDE CATHETER WAS PULLED FURTHER AND FURTHER INTO THE LEFT MAIN CORONARY ARTERY BY THE ENTANGLED WIRE AND CAUSED A DISSECTION, RESULTING IN PATIENT DEATH. UNDER ANGIO, THERE WAS NO PHYSICAL DAMAGE OR PROTRUDING PARTS OBSERVED ON THE WIRE. ALL PORTIONS OF THE WIRE APPEAR TO BE ACCOUNTED FOR WHEN IT WAS REMOVED FROM THE PATIENT POST-MORTEM. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED DUE TO ENTRAPMENT, AND ATTEMPT TO REMOVE THE WIRE CAUSED A DISSECTION, RESULTING IN PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1912712 OMNIWIRE PRESSURE GUIDE WIRE WIRE, GUIDE, CATHETER DQX VOLCANO CORPORATION 89185 0303194162 00845225003043

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Death BOSTON SCIENTIFIC, PROMUS 2.75X16 STENT.| BOSTON SCIENTIFIC, PROMUS 2.75X20 STENT.| MEDTRONIC, 6F EBU 3.5 GUIDE CATHETER.| PHILIPS, INTRASIGHT MOBILE CONSOLE.| TERUMO INTRODUCER SHEATH, SIZE UNK.