BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIWIRE PRESSURE GUIDE WIRE

    MDR report key: 20349449 · Received October 1, 2024

    Report

    Report Number
    3008363989-2024-00062
    Event Type
    Malfunction
    Date Received
    October 1, 2024
    Date of Event
    September 19, 2024
    Report Date
    November 5, 2024
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    DQX
    UDI-DI
    00845225003043
    PMA / PMN Number
    K192886
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK G: SITE NAME AND ADDRESS CORRECTED FROM VOLCANO CORPORATION LOCATION TO VOLCARICA S.R.L LOCATION. BLOCKS H7, H9 & H10: DO NOT APPLY TO THIS SUBMISSION. (INITIAL MDR LISTED BLOCKS H7, H9 & H9).

    Additional Manufacturer Narrative · 0

    BLOCK B5: THIS IS NO LONGER A REPORTABLE EVENT FOR MEASUREMENT DRIFT AS IT DOES NOT MEET THE FOLLOWING: STEP 1: THE WIRE MUST HAVE BEEN SUCCESSFULLY NORMALIZED BEFORE PROCEEDING TO THE LESION SITE OF INTEREST. STEP 2: THE IFR/FFR MEASUREMENT MUST HAVE ALREADY BEEN SUCCESSFULLY OBTAINED. STEP 3: THE DRIFT MUST OCCUR DURING THE SECOND NORMALIZATION INSIDE THE GUIDE CATHETER AFTER THE MEASUREMENT. BLOCK H6: MEDICAL DEVICE PROBLEM HAS BEEN UPDATED TO IMDRF #A090811 (UNABLE TO OBTAIN READINGS) FROM IMDRF #A090805 (INCORRECT MEASUREMENT). 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-A4: NO INFORMATION AVAILABLE. BLOCKS B6 & B7: NO INFORMATION AVAILABLE. BLOCK C: NOT APPLICABLE FOR THIS DEVICE. BLOCKS D6 & D7: NOT APPLICABLE FOR THIS DEVICE. BLOCKS E1 & G2: COUNTRY IS JAPAN. BLOCKS H3 & H6: THE OMNIWIRE WIRE WAS NOT RETURNED FOR EVALUATION, THUS NO RETURNED PRODUCT INVESTIGATION WAS PERFORMED. BLOCKS H7, H9 & 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

    FURTHER REVIEW DETERMINED THAT THIS IS NOT A MEASUREMENT DRIFT COMPLAINT AND HAS BEEN RECLASSIFIED TO "COULD NOT NORMALIZE". THIS FAILURE OCCURRED PRIOR TO MEASUREMENT; THEREFORE, THE IFR/FFR MEASUREMENTS COULD NOT BE OBTAINED. THIS IS NO LONGER REPORTABLE AS THERE IS NO POTENTIAL FOR INACCURATE MEASUREMENTS WITH RECURRENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A OMNIWIRE PRESSURE GUIDEWIRE WAS USED IN A DIAGNOSTIC CORONARY PROCEDURE. DURING USE, MEASUREMENT DRIFT WAS EXPERIENCED OUTSIDE THE ACCEPTABLE PARAMETERS. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED DUE TO MEASUREMENT DRIFT. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1948447 OMNIWIRE PRESSURE GUIDE WIRE WIRE, GUIDE, CATHETER DQX VOLCANO CORPORATION 89185 0303187780 00845225003043

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown GUIDE CATHETER, MFG AND SIZE UNK| INTRODUCER SHEATH, MFG AND SIZE UNK| PHILIPS: INTRASIGHT MOBILE CONSOLE